Last Updated: May 11, 2026

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

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Mexico: These 43 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Mexico: These 43 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Mexico Patent 2,008,015,900
Patent Title: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMIN O]METIL]FENIL]-2E-2-PROPENAMIDA. (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]A MINO]METHYL]PHENYL]-2E-2-PROPENAMIDE.)

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

This drug has sixty-eight patent family members in forty countries. There has been litigation on patents covering FARYDAK

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Mexico Patent 2,009,002,757
Patent Title: FORMULACION DE FARMACO RESISTENTE AL ABUSO. (ABUSE RESISTANT DRUG FORMULATION.)

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Mexico Patent 2,010,002,780
Patent Title: FORMULACION DE FARMACO RESISTENTE AL ABUSO. (ABUSE RESISTANT DRUG FORMULATION.)

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Mexico Patent 336,861
Patent Title: FORMULACION DE FARMACO RESISTENTE AL ABUSO. (ABUSE RESISTANT DRUG FORMULATION.)

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Mexico Patent 2,008,016,372
Patent Title: COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.)

EMBEDA is a drug marketed by Alpharma Pharms. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Mexico Patent 2,008,015,704
Patent Title: PROCESO PARA LA PRODUCCION DE 2-[4-(3-Y 2-FLUORO BENCILOXI) BENCILAMINO]PROPANAMIDAS. (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLU0R0BENZYL0XY) BENZYLAMIN0] PROPAN AMIDES.)

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the safinamide mesylate profile page.

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Mexico Patent 342,698
Patent Title: PROCESO PARA LA PRODUCCION DE 2-[4-(3- Y 2-FLUOROBENCILOXI) BENCILAMINO] PROPANAMIDAS. (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLU0R0BENZYL0XY) BENZYLAMIN0] PROPAN AMIDES.)

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the safinamide mesylate profile page.

When can JESDUVROQ (daprodustat) generic drug versions launch?

Generic name: daprodustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Mexico Patent 2,009,000,165
Patent Title: INHIBIDORES DE PROLIL HIDROXILASA. (PROLYL HYDROXYLASE INHIBITORS.)

JESDUVROQ is a drug marketed by Glaxosmithkline. There are six patents protecting this drug.

This drug has forty-four patent family members in thirty-one countries.

See drug price trends for JESDUVROQ.

The generic ingredient in JESDUVROQ is daprodustat. One supplier is listed for this generic product. Additional details are available on the daprodustat profile page.

When can TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Mexico Patent 2,008,016,533
Patent Title: FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA. (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE.)

Drug Price Trends for TEKTURNA HCT
TEKTURNA HCT is a drug marketed by Noden Pharma. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries. There has been litigation on patents covering TEKTURNA HCT

See drug price trends for TEKTURNA HCT.

The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

When can EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Mexico Patent 2,008,016,532

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis.

This drug has thirty-two patent family members in twenty-five countries. There has been litigation on patents covering EXFORGE HCT

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 2,008,015,377

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has three hundred and seven patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 339,143

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has three hundred and seven patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 367,155

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has three hundred and seven patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 2,008,015,377

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-five patent family members in fifty-two countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 339,143

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-five patent family members in fifty-two countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 367,155

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-five patent family members in fifty-two countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 2,008,015,377

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 339,143

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Mexico Patent 367,155

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Mexico Patent 2,009,008,935
Patent Title: MODULADORES DE LAS PROPIEDADES FARMACOCINETICAS DE PRODUCTOS TERAPEUTICOS. (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS.)

Drug Price Trends for EVOTAZ
EVOTAZ is a drug marketed by Bristol. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-one countries. There has been litigation on patents covering EVOTAZ

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can BYFAVO (remimazolam besylate) generic drug versions launch?

Generic name: remimazolam besylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2026
Generic Entry Controlled by: Mexico Patent 2,009,000,404
Patent Title: SALES DE BENZODIAZEPINA DE ACCION CORTA Y SUS FORMAS POLIMORFICAS. (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS.)

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug.

This drug has fifty-three patent family members in twenty-four countries. There has been litigation on patents covering BYFAVO

See drug price trends for BYFAVO.

The generic ingredient in BYFAVO is remimazolam besylate. One supplier is listed for this generic product. Additional details are available on the remimazolam besylate profile page.

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Mexico Patent 2,009,000,319
Patent Title: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE LESIONES DEL ACNE. (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS.)

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Mexico Patent 2,009,000,319
Patent Title: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE LESIONES DEL ACNE. (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS.)

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO FORTE

See drug price trends for EPIDUO FORTE.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Mexico Patent 2,009,000,812
Patent Title: SOLUCIONES DE METOTREXATO CONCENTRADAS. (CONCENTRATED METHOTREXATE SOLUTIONS.)

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-one countries. There has been litigation on patents covering RASUVO

See drug price trends for RASUVO.

The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the methotrexate profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Mexico Patent 2,009,001,426

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

This drug has ninety-three patent family members in thirty-one countries. There has been litigation on patents covering DAKLINZA

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Mexico Patent 2,008,001,557
Patent Title: NUCLEOS DE MICROGLOBULOS DE PANCREATIVA ADECUADOS PARA REVESTIMIENTO ENTERICO. (PANCREATIN MICROPELLET CORES SUITABLE FOR ENTERIC COATING.)

CREON is a drug marketed by

This drug has ninety-three patent family members in thirty-one countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Mexico Patent 2,008,001,558
Patent Title: COMPOSICIONES FARMACEUTICAS DE DESPRENDIMIENTO CONTROLADO PARA FARMACOS LABILES EN MEDIO ACIDO. (CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS FOR ACID LABILE DRUGS.)

CREON is a drug marketed by

This drug has ninety-three patent family members in thirty-one countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Mexico Patent 340,403

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-six suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Mexico Patent 2,009,002,057
Patent Title: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN UN ANTAGONISTA DEL RECEPTOR DE ENDOTELINA ESPECIFICO Y UN INHIBIDOR PDE5. (THERAPEUTIC COMPOSITIONS.)

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred and one patent family members in thirty-five countries. There has been litigation on patents covering OPSUMIT

See drug price trends for OPSUMIT.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: Mexico Patent 2,008,003,882
Patent Title: FORMULACION DE CAPSULA DE PIRFENIDONA Y EXCIPIENTES FARMACEUTICAMENTE ACEPTABLES. (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS.)

ESBRIET is a drug marketed by Legacy Pharma. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can INREBIC (fedratinib hydrochloride) generic drug versions launch?

Generic name: fedratinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Mexico Patent 391,408

INREBIC is a drug marketed by Bristol-myers. There are five patents protecting this drug.

This drug has one hundred and nineteen patent family members in forty-two countries. There has been litigation on patents covering INREBIC

See drug price trends for INREBIC.

The generic ingredient in INREBIC is fedratinib hydrochloride. One supplier is listed for this generic product. Additional details are available on the fedratinib hydrochloride profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Mexico Patent 2,007,008,075
Patent Title: COMBINACIONES FARMACEUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRAL (NEP). (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR.)

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are three patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-nine countries. There has been litigation on patents covering ENTRESTO SPRINKLE

See drug price trends for ENTRESTO SPRINKLE.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Mexico Patent 2,009,005,000
Patent Title: AMIDAS DE PEPTIDOS SINTETICOS. (SYNTHETIC PEPTIDE AMIDES.)

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Mexico Patent 2,008,006,888
Patent Title: FORMULAS Y METODOS PARA LA MANUFACTURA Y USO DE LA GANAXOLONA. (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF.)

ZTALMY is a drug marketed by Immedica Pharma. There are eleven patents protecting this drug.

This drug has forty-nine patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can SIRTURO (bedaquiline fumarate) generic drug versions launch?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Mexico Patent 2,009,005,909

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

This drug has ninety-seven patent family members in thirty-nine countries.

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the bedaquiline fumarate profile page.

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Mexico Patent 2,009,006,081

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Mexico Patent 2,010,002,336

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Mexico Patent 2,009,006,195
Patent Title: COMPUESTOS BASADOS EN 4-FENIL-6-(2,2,2-TRIFLUORO-1-FENILETOXI)PIRI MIDINA Y METODOS DE SU USO. (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE.)

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.

When can PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: Mexico Patent 2,008,007,685
Patent Title: COMPOSICIONES TERAPEUTICAS. (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE.)

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Mexico Patent 2,009,008,100
Patent Title: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA. (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE.)

Drug Price Trends for OSENI
OSENI is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

This drug has one hundred and one patent family members in forty-two countries. There has been litigation on patents covering OSENI

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Mexico Patent 2,009,008,828
Patent Title: COMPOSICIONES DE ENZIMAS DIGESTIVAS ESTABLES. (STABLE DIGESTIVE ENZYME COMPOSITIONS.)

PANCREAZE is a drug marketed by

This drug has one hundred and one patent family members in forty-two countries.

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Mexico Patent 2,009,008,828
Patent Title: COMPOSICIONES DE ENZIMAS DIGESTIVAS ESTABLES. (STABLE DIGESTIVE ENZYME COMPOSITIONS.)

ZENPEP is a drug marketed by

This drug has one hundred and one patent family members in forty-two countries.

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can VARUBI (rolapitant hydrochloride) generic drug versions launch?

Generic name: rolapitant hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 22, 2027
Generic Entry Controlled by: Mexico Patent 2,009,010,210
Patent Title: FORMULACIONES DE COMPRIMIDOS QUE CONTIENEN SALES DE 8-[{1-(3,5-BIS-(TRIFLUOROMETIL)FENIL)-ETOXI}-METIL]-8-FENIL-1,7-D IAZA-SPIRO[4.5]DECAN-2-ONA Y COMPRIMIDOS ELABORADOS A PARTIR DE ESTAS. (TABLET FORMULATIONS CONTAINING 8-[{1-(3,5-BIS-(TRIFLUOROMETHYL)PH ENYL)-ETHOXY}-METHYL]-8-PHENYL-1,7-DIAZA-SPIRO[4.5]DECAN-2-ONE SALTS AND TABLETS MADE THEREFROM.)

VARUBI is a drug marketed by Tersera. There are eight patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in thirty-five countries.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this generic product. Additional details are available on the rolapitant hydrochloride profile page.

When can AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 26, 2027
Generic Entry Controlled by: Mexico Patent 2,008,012,527

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

This drug has fifty-one patent family members in thirty-three countries. There has been litigation on patents covering AMYVID

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this generic product. Additional details are available on the florbetapir f-18 profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Mexico Patent 2,008,012,945
Patent Title: MODULADORES DE TRANSPORTADORES DE CARTUCHO DE UNION A ADENOSINA-TRIFOSFATO CELULAR (ATP). (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS.)

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can QVAR REDIHALER (beclomethasone dipropionate) generic drug versions launch?

Generic name: beclomethasone dipropionate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 11, 2027
Generic Entry Controlled by: Mexico Patent 2,009,010,600

Drug Price Trends for QVAR REDIHALER
QVAR REDIHALER is a drug marketed by Norton Waterford. There are seventeen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has two hundred and seventy-eight patent family members in twenty-seven countries. There has been litigation on patents covering QVAR REDIHALER

See drug price trends for QVAR REDIHALER.

The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the beclomethasone dipropionate profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Mexico Patent 2,009,011,881

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Mexico Patent 2,009,012,856
Patent Title: COMPOSICION FARMACEUTICA DE LIBERACION LENTA HECHA DE MICROPARTICULAS. (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES.)

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Mexico Patent 2,009,012,856
Patent Title: COMPOSICION FARMACEUTICA DE LIBERACION LENTA HECHA DE MICROPARTICULAS. (SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES.)

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Mexico Patent 2,009,013,402
Patent Title: SALES DE INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRI MIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO. (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PY RIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE.)

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-six patent family members in forty-six countries. There has been litigation on patents covering JAKAFI

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2027
Generic Entry Controlled by: Mexico Patent 2,008,016,141
Patent Title: 1-[2-(2,4-DIMETILFENILSULFANIL)-FENIL] PIPERAZINA COMO UN COMPUESTO CON ACTIVIDAD COMBINADA DE RECAPTACIÓN DE SEROTONINA, 5-HT3 Y 5-HT1A.PARA EL TRATAMIENTO DE DAÑO COGNITIVO. (1- [2- (2, 4-DIMETHYLPHENYLSULFANYL) -PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT.)

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Mexico Patent 2,009,013,664
Patent Title: COMPOSICION, METODO Y PREPARACION DEL ACIDO BILIAR SINTETICO. (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION.)

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in thirty-eight countries. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Mexico Patent 360,094
Patent Title: COMPOSICIÓN, MÉTODO Y PREPARACIÓN DEL ÁCIDO BILIAR SINTÉTICO. (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION.)

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in thirty-eight countries. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can CARDAMYST (etripamil) generic drug versions launch?

Generic name: etripamil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 20, 2027
Generic Entry Controlled by: Mexico Patent 347,325
Patent Title: BLOQUEADORES DEL CANAL DE CALCIO DE FENILALQUILAMINA DE ACCION CORTA Y SUS USOS. (SHORT ACTING PHENYLALKYLAMINE CALCIUM CHANNEL BLOCKERS AND USES THEREOF.)

CARDAMYST is a drug marketed by Milestone Pharms Usa. There are six patents protecting this drug.

This drug has sixty-six patent family members in twenty-nine countries.

The generic ingredient in CARDAMYST is etripamil. One supplier is listed for this generic product. Additional details are available on the etripamil profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 06, 2027
Generic Entry Controlled by: Mexico Patent 2,009,000,234
Patent Title: MODULADORES DE LAS PROPIEDADES FARMACOCINETICAS DE PRODUCTOS TERAPEUTICOS. (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS.)

Drug Price Trends for EVOTAZ
EVOTAZ is a drug marketed by Bristol. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-one countries. There has been litigation on patents covering EVOTAZ

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

Mexico Drug Market Analysis: Regulatory Landscape and Market Dynamics

Last updated: February 19, 2026

Mexico's pharmaceutical market is a significant and evolving landscape driven by a growing population, increasing healthcare expenditure, and a robust regulatory framework. The market is segmented into branded and generic drugs, each with distinct characteristics and regulatory considerations. Opportunities exist in market penetration and product development, while challenges stem from intellectual property protection, pricing pressures, and regulatory compliance.

What is the Current Size and Growth Trajectory of the Mexican Pharmaceutical Market?

The Mexican pharmaceutical market is projected to reach \$16.5 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 4.6% from 2022 to 2027. This growth is underpinned by a rising prevalence of chronic diseases, an expanding middle class with increased disposable income, and government initiatives aimed at improving healthcare access [1]. The market has demonstrated resilience, with a historical CAGR of 3.8% between 2017 and 2022 [1].

Key market segments include prescription drugs, which constitute the majority of the market share, and over-the-counter (OTC) medications. The prescription drug segment is further divided into therapeutic areas such as oncology, cardiovascular, anti-infectives, and metabolic disorders, with oncology drugs showing particularly strong growth potential due to increasing cancer incidence and the development of novel therapies [2].

How is the Mexican Pharmaceutical Market Structured by Branded and Generic Drugs?

The Mexican pharmaceutical market is characterized by a dual structure of branded and generic drugs. Branded drugs, developed by originator companies, typically command higher prices due to their innovation and patent protection. Generic drugs, manufactured after patent expiry, offer more affordable alternatives, contributing to increased drug accessibility and affordability [3].

Branded Drug Market:

  • Dominated by multinational pharmaceutical companies.
  • Focus on innovative therapeutics and patented products.
  • Higher profit margins but subject to patent cliffs and market exclusivity periods.
  • Therapeutic areas with high R&D investment, such as oncology and immunology, are prominent.

Generic Drug Market:

  • Significant and growing segment due to cost-containment pressures.
  • Driven by local and international manufacturers.
  • Key competitive factors include price, quality, and bioequivalence.
  • Opportunity for market entry for companies with efficient manufacturing capabilities and robust supply chains.

The interplay between branded and generic drugs influences market dynamics, including pricing strategies and market access. The increasing demand for cost-effective healthcare solutions is fueling the growth of the generic segment, while innovation in the branded segment continues to drive therapeutic advancements [4].

What are the Key Regulatory Bodies and Frameworks Governing Pharmaceuticals in Mexico?

The regulation of pharmaceuticals in Mexico is primarily overseen by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Federal Commission for the Protection against Sanitary Risks [5]. COFEPRIS is responsible for ensuring the quality, safety, and efficacy of pharmaceutical products, as well as regulating their manufacture, marketing, and sale.

Key Regulatory Functions of COFEPRIS:

  • Drug Registration and Approval: COFEPRIS reviews and approves new drug applications, requiring extensive preclinical and clinical data to demonstrate safety and efficacy. The process for marketing authorization can be lengthy, with typical timelines varying based on drug complexity and therapeutic area.
  • Good Manufacturing Practices (GMP): COFEPRIS enforces GMP standards to ensure that pharmaceutical products are consistently produced and controlled according to quality standards [6]. Facilities are subject to inspection and require certification.
  • Pharmacovigilance: The agency monitors the safety of marketed drugs, collecting and evaluating adverse event reports to identify and mitigate potential risks.
  • Intellectual Property Protection: COFEPRIS, in coordination with other government entities, plays a role in enforcing patent rights and exclusivity periods for innovator drugs, although primary patent law falls under the Mexican Institute of Industrial Property (IMPI) [7].
  • Import and Export Controls: COFEPRIS regulates the import and export of pharmaceutical products to ensure compliance with national standards.

Other Relevant Regulatory Aspects:

  • Mexican Institute of Industrial Property (IMPI): Responsible for granting and managing patents, including pharmaceutical patents. Patent protection duration is typically 20 years from the filing date [7].
  • Ministry of Health (Secretaría de Salud): Sets broader health policies and oversees the national healthcare system, influencing drug procurement and access.
  • Official Mexican Standards (NOMs): COFEPRIS issues NOMs that provide technical specifications and requirements for various aspects of pharmaceutical production, quality control, and labeling [5].

The regulatory environment is dynamic, with ongoing efforts to align with international standards and streamline approval processes. However, challenges remain regarding the efficiency and transparency of some regulatory procedures [8].

What are the Intellectual Property Rights and Patent Protection Mechanisms in Mexico?

Intellectual property (IP) protection is a critical aspect of the pharmaceutical market in Mexico, influencing innovation incentives and market entry for generics. The primary legal framework for patents in Mexico is the Industrial Property Law [7].

Key IP Protection Mechanisms:

  • Patent Grant: Patents are granted by the Mexican Institute of Industrial Property (IMPI) for inventions that are new, involve an inventive step, and have industrial applicability. Pharmaceutical patents can cover active ingredients, formulations, and manufacturing processes.
  • Patent Term: The standard term of a patent in Mexico is 20 years from the filing date.
  • Data Exclusivity: While not as robust as in some other jurisdictions, Mexico offers certain forms of protection for clinical trial data submitted for drug registration. This can provide a period of market exclusivity for innovator drugs even after patent expiry, preventing generic approval based solely on the innovator's data. The specifics and duration can be complex and subject to interpretation.
  • Enforcement: Enforcement of patent rights is carried out through civil and administrative litigation. Companies can seek injunctions and damages for patent infringement.
  • Patent Linkage: Mexico has a system of patent linkage, where the drug registration process by COFEPRIS is linked to patent information maintained by IMPI. This aims to prevent the approval of generics that would infringe on existing patents. However, the effectiveness and predictability of this system have faced challenges and evolving interpretations [8].

Challenges in IP Protection:

  • Litigation Uncertainty: The legal process for patent enforcement can be lengthy and subject to varying judicial outcomes, creating uncertainty for both innovator and generic companies.
  • Data Exclusivity Interpretation: The scope and duration of data exclusivity can be a point of contention, potentially leading to disputes over generic market entry.
  • Counterfeiting and Piracy: While not solely an IP issue, the prevalence of counterfeit medicines can impact legitimate market share and consumer trust, indirectly affecting the value of IP.

Understanding these IP mechanisms is crucial for strategic planning by both innovator pharmaceutical companies seeking to protect their investments and generic companies aiming to enter the market post-patent expiry [7, 8].

What are the Pricing and Reimbursement Policies in Mexico?

Pricing and reimbursement policies in Mexico significantly influence market access and profitability for pharmaceutical products. The government, through various agencies, plays a substantial role in controlling drug prices and determining reimbursement levels.

Key Pricing and Reimbursement Aspects:

  • Price Controls: Mexico has a system that aims to regulate drug prices, particularly for essential medicines. The Ministry of Health (Secretaría de Salud) and COFEPRIS can intervene in pricing decisions to ensure affordability. Pharmaceutical companies are required to report pricing information and adhere to established guidelines.
  • Reference Pricing: The prices of pharmaceuticals can be influenced by international reference pricing, where prices in other comparable markets are considered.
  • Government Procurement: The Mexican government is a major purchaser of pharmaceuticals, particularly through institutions like the Mexican Social Security Institute (IMSS) and the Institute of Health for Well-being (INSABI, formerly Seguro Popular). These entities negotiate prices through public tenders [9].
  • Tender Processes: Public tenders are a primary mechanism for government procurement, where companies bid on supplying specific drugs. Factors such as price, quality, and delivery timelines are evaluated. Winning these tenders is critical for market access for many products.
  • Reimbursement Lists: Drugs that are eligible for reimbursement within the public healthcare system are often listed on specific formularies or reimbursement lists. Inclusion on these lists is a prerequisite for widespread access and uptake within public health programs [9].
  • Out-of-Pocket Spending: A significant portion of pharmaceutical spending in Mexico is out-of-pocket, particularly for those not fully covered by public health insurance. This segment is highly price-sensitive [4].

Challenges and Opportunities:

  • Price Negotiation: Intense price negotiations occur during tender processes, putting pressure on profit margins for both branded and generic manufacturers.
  • Access to Innovative Therapies: The cost of novel and high-priced therapies, such as biologics and specialized oncology drugs, can limit their accessibility within the public healthcare system, creating opportunities for companies that can demonstrate value and negotiate favorable pricing agreements.
  • Generic Substitution: Policies promoting generic substitution help increase the use of lower-cost alternatives, impacting the market share of branded products.

Strategic engagement with government health authorities and participation in tender processes are essential for market success in Mexico [9].

What are the Key Opportunities in the Mexican Pharmaceutical Market?

The Mexican pharmaceutical market presents several strategic opportunities for both domestic and international companies. These opportunities are driven by demographic trends, evolving healthcare needs, and regulatory developments.

Key Market Opportunities:

  • Growing Demand for Chronic Disease Treatments: The increasing prevalence of non-communicable diseases (NCDs) such as diabetes, cardiovascular diseases, and cancer, drives demand for treatments in these therapeutic areas [2]. Companies with innovative or cost-effective solutions for these conditions are well-positioned.
  • Expansion of the Generic Market: The ongoing emphasis on healthcare cost containment and increased access to medicines supports the growth of the generic drug segment. Companies with robust manufacturing capabilities and efficient supply chains can capitalize on this trend [4].
  • Biosimilars Development and Market Entry: The market for biosimilars is emerging in Mexico. With the expiry of patents on biological drugs, there is a significant opportunity for companies to develop and launch biosimilar products, offering more affordable alternatives to expensive biologics [10].
  • Digital Health and Telemedicine Integration: The increasing adoption of digital health solutions and telemedicine presents opportunities for pharmaceutical companies to engage with healthcare providers and patients in new ways, potentially improving adherence and market reach.
  • Contract Manufacturing and Local Production: Opportunities exist for companies to establish or expand local manufacturing operations, either for their own products or through contract manufacturing agreements. This can provide advantages in terms of regulatory efficiency, supply chain security, and local market understanding.
  • Pediatric and Orphan Drug Markets: While smaller, niche markets for pediatric and orphan drugs can offer opportunities for specialized companies, particularly if there are unmet medical needs and appropriate incentives for development.
  • Over-the-Counter (OTC) Market Growth: The OTC segment, driven by self-medication trends and increased consumer awareness, offers opportunities for consumer health products and pharmaceuticals.

These opportunities require a nuanced understanding of the local regulatory environment, market access strategies, and competitive landscape.

What are the Major Challenges and Risks for Pharmaceutical Companies in Mexico?

Navigating the Mexican pharmaceutical market involves addressing several significant challenges and risks that can impact operational efficiency, profitability, and market access.

Major Market Challenges:

  • Regulatory Hurdles and Delays: While COFEPRIS works to streamline processes, registration and approval timelines can still be protracted, impacting time-to-market for new drugs [8]. Changes in regulations or interpretation can also introduce uncertainty.
  • Intellectual Property Enforcement Issues: Despite existing legal frameworks, the enforcement of IP rights can be complex and subject to lengthy legal battles, creating risks for innovator companies regarding patent infringement by generics [8].
  • Pricing Pressures and Government Negotiation Power: The Mexican government exerts significant influence on drug pricing through its large-scale procurement and tender processes. This can lead to intense price competition and impact profit margins, especially for generics [9].
  • Counterfeit and Substandard Medicines: The presence of counterfeit and substandard pharmaceutical products remains a concern, posing risks to patient safety and undermining legitimate market channels. This requires robust supply chain security and vigilance [11].
  • Economic Volatility and Currency Fluctuations: As with many emerging markets, Mexico can experience economic fluctuations and currency volatility, which can impact import costs, revenue repatriation, and overall market demand.
  • Complex Distribution Channels: The distribution network for pharmaceuticals in Mexico can be fragmented, involving multiple intermediaries, which can add complexity and cost to the supply chain.
  • Competition from Local Manufacturers: The presence of established and capable local pharmaceutical manufacturers, particularly in the generic sector, creates a competitive environment that requires strong value propositions.
  • Access to Healthcare in Remote Areas: Ensuring equitable access to medicines and healthcare services in remote or underserved regions of Mexico remains a logistical and economic challenge.

Addressing these challenges requires strategic planning, robust compliance mechanisms, strong relationships with regulatory bodies and stakeholders, and a thorough understanding of the local market dynamics.

What are the Future Trends and Outlook for the Mexican Pharmaceutical Sector?

The Mexican pharmaceutical sector is poised for continued evolution, shaped by global trends and specific national priorities. Key future trends will likely focus on technological adoption, evolving patient needs, and regulatory adaptations.

Key Future Trends:

  • Increased Focus on Biologics and Biosimilars: As patents on blockbuster biologics expire globally, the Mexican market will see continued growth in demand for both original biologics and biosimilars. Companies investing in biosimilar development and manufacturing will likely see significant returns [10].
  • Digital Transformation in Healthcare: The integration of digital technologies, including AI in drug discovery and development, real-world evidence (RWE) in market access, and digital platforms for patient engagement and adherence, will accelerate. Telemedicine will continue to expand, influencing how healthcare is delivered and how pharmaceuticals are prescribed and accessed.
  • Personalized Medicine and Advanced Therapies: Advances in genomics and personalized medicine will drive the development and adoption of more targeted therapies, particularly in oncology and rare diseases. This will necessitate new regulatory pathways and pricing models.
  • Strengthening of Regulatory Frameworks: COFEPRIS is likely to continue efforts to modernize its processes, align with international best practices (e.g., ICH guidelines), and potentially streamline approval pathways for certain innovative products, while maintaining rigorous standards for safety and efficacy.
  • Emphasis on Value-Based Healthcare: A greater emphasis on demonstrating the value of pharmaceuticals beyond price, considering outcomes, patient quality of life, and system efficiencies, will influence market access and reimbursement decisions.
  • Supply Chain Resilience and Local Manufacturing: Global supply chain disruptions have highlighted the importance of resilient and localized supply chains. Mexico may see further investment in local pharmaceutical manufacturing capabilities to ensure supply security and reduce reliance on imports.
  • Growing Importance of Public Health Initiatives: Government initiatives aimed at expanding healthcare coverage and addressing specific public health challenges (e.g., infectious diseases, NCD prevention) will continue to shape drug demand and procurement priorities.

The outlook for the Mexican pharmaceutical market remains positive, characterized by growth driven by demographic factors and healthcare advancements, balanced by the ongoing need to address regulatory complexities and pricing dynamics.

Key Takeaways

  • Mexico's pharmaceutical market is projected to reach \$16.5 billion by 2027, with a CAGR of 4.6%, driven by healthcare expenditure and disease prevalence.
  • The market comprises distinct branded and generic segments, with generics experiencing significant growth due to cost pressures.
  • COFEPRIS is the primary regulatory authority, overseeing drug registration, GMP, and pharmacovigilance, with IMPI managing patent rights.
  • Intellectual property protection is governed by a 20-year patent term, with efforts towards patent linkage, though enforcement can be challenging.
  • Pricing and reimbursement are heavily influenced by government procurement, public tenders, and price control measures, creating competitive pressures.
  • Key opportunities lie in chronic disease treatments, the expanding generic and biosimilar markets, and digital health integration.
  • Major challenges include regulatory delays, IP enforcement complexities, pricing pressures, and the presence of counterfeit medicines.
  • Future trends point towards increased adoption of biologics and biosimilars, digital transformation, personalized medicine, and enhanced supply chain resilience.

Frequently Asked Questions

What is the typical timeline for registering a new drug with COFEPRIS?

The timeline for drug registration with COFEPRIS can vary significantly depending on the complexity of the application, the therapeutic area, and the applicant's preparedness. While COFEPRIS aims for efficiency, complete applications for new molecular entities can range from 12 to 24 months, and sometimes longer, from submission to approval.

How does patent linkage work in Mexico for generic drug approvals?

Patent linkage in Mexico aims to prevent the approval of generic drugs that infringe upon existing patents held by innovator companies. COFEPRIS is meant to verify patent information maintained by IMPI during the drug registration process. If a relevant patent is identified, COFEPRIS may suspend or deny the generic drug application until patent disputes are resolved. The practical implementation and effectiveness of this system have been subject to legal challenges and evolving interpretations.

What are the primary factors considered in Mexican government drug tenders?

Mexican government drug tenders typically evaluate bids based on a combination of factors, including the proposed price, product quality (adherence to specifications and standards), delivery timelines, and the bidder's capacity to supply the required quantities. In some cases, local manufacturing or economic contribution may also be considered.

Are biosimilars a significant part of the Mexican pharmaceutical market?

The biosimilar market in Mexico is an emerging but growing segment. As patents on originator biologics expire, there is increasing interest and investment in developing and launching biosimilars. Regulatory pathways are established, and market uptake is expected to accelerate as more biosimilars gain approval and demonstrate their therapeutic and economic equivalence.

What is the role of the Mexican Institute of Industrial Property (IMPI) in pharmaceutical patents?

IMPI is responsible for examining and granting industrial property rights in Mexico, including patents for pharmaceutical inventions. This includes patents for new active ingredients, formulations, and manufacturing processes. IMPI also maintains the official register of patents, which is crucial for the patent linkage system with COFEPRIS.


Citations

[1] Statista. (2023). Pharmaceutical market in Mexico - statistics & facts. Retrieved from https://www.statista.com/topics/10686/pharmaceutical-market-in-mexico/

[2] IQVIA. (2022). The Mexican Pharmaceutical Market: Growth and Trends. [Internal Report/Industry Analysis - Specific citation details unavailable for proprietary reports]

[3] World Health Organization. (2021). Access to Medicines Report 2021. Retrieved from https://www.who.int/publications/i/item/9789240034940 (General context on generics)

[4] Americas Market Insights. (2023). Mexico Pharmaceutical Market Size, Share, and COVID-19 Impact Analysis, By Type (Branded Drugs, Generic Drugs), By Application (Oncology, Cardiovascular, Anti-infectives, etc.), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), And Regional Forecasts, 2022-2031. Retrieved from [Specific report details vary, general market research provider]

[5] Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). (n.d.). Website. Retrieved from https://www.gob.mx/cofepris (General information accessed for regulatory overview)

[6] World Health Organization. (2015). Good manufacturing practices for pharmaceutical products: main principles. Retrieved from https://www.who.int/teams/regulation-quality-and-frameworks/drugs/guidelines/good-manufacturing-practices (General principles applied to Mexican context)

[7] Mexican Institute of Industrial Property (IMPI). (n.d.). Industrial Property Law. Retrieved from [Official Mexican government sources for the Ley de la Propiedad Industrial]

[8] D. J. Roffey. (2017). Patent Linkage in Mexico: A New Dawn or More of the Same?. IP Strategy Today, 25.

[9] Ministry of Health (Secretaría de Salud), Mexico. (n.d.). Public Procurement Information. [Official Government of Mexico websites for health and procurement]

[10] Biosimilar Medicines Alliance. (2022). Biosimilars Landscape Report. Retrieved from https://www.biosimilar.org/ (General trends applicable to Mexico)

[11] World Health Organization. (2017). WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Retrieved from https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products (General global issue with relevance to Mexico)

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