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Last Updated: December 28, 2025

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 28 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Mexico: These 28 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 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 RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Mexico Patent 2,008,010,394
Patent Title: TRATAMIENTOS ANTIVIRALES INTRAVENOSOS. (INTRAVENOUS ANTIVIRAL TREATMENTS.)

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

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

When can XIFAXAN (rifaximin) generic drug versions launch?

Generic name: rifaximin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 27, 2026
Generic Entry Controlled by: Mexico Patent 2,007,010,742
Patent Title: NUEVAS FORMAS POLIMORFAS DE RIFAXIMINA, PROCEDIMIENTOS PARA SU PRODUCCION Y USO DE LA MISMA EN PREPARACIONES MEDICINALES. (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL.)

Drug Price Trends for XIFAXAN
XIFAXAN is a drug marketed by Salix Pharms. There are twenty-two patents protecting this drug and two Paragraph IV challenges. Four tentatively approved generics are ready to enter the market.

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

See drug price trends for XIFAXAN.

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

When can OZEMPIC (semaglutide) generic drug versions launch?

Generic name: semaglutide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2026
Generic Entry Controlled by: Mexico Patent 2,007,011,220
Patent Title: COMPUESTOS DE PEPTIDO 1 TIPO GLUCAGON ACILADOS. (ACYLATED GLP-1 COMPOUNDS.)

Drug Price Trends for OZEMPIC
OZEMPIC is a drug marketed by Novo. There are nineteen patents protecting this drug.

This drug has two hundred and thirty-eight patent family members in thirty-three countries. There has been litigation on patents covering OZEMPIC

See drug price trends for OZEMPIC.

The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this generic product. Additional details are available on the semaglutide profile page.

When can WEGOVY (semaglutide) generic drug versions launch?

Generic name: semaglutide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2026
Generic Entry Controlled by: Mexico Patent 2,007,011,220
Patent Title: COMPUESTOS DE PEPTIDO 1 TIPO GLUCAGON ACILADOS. (ACYLATED GLP-1 COMPOUNDS.)

Drug Price Trends for WEGOVY
WEGOVY is a drug marketed by Novo. There are nine patents protecting this drug.

This drug has one hundred and eighty-two patent family members in thirty-three countries. There has been litigation on patents covering WEGOVY

See drug price trends for WEGOVY.

The generic ingredient in WEGOVY is semaglutide. Two suppliers are listed for this generic product. Additional details are available on the semaglutide 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 30, 2026
Generic Entry Controlled by: Mexico Patent 2,008,012,527
Patent Title: DERIVADOS DE ESTIRILPIRIDINA Y SUS USOS PARA UNION A PLACAS AMILOIDES Y OBTENCION DE IMAGENES DE LAS MISMAS. (STYRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES.)

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 LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Mexico Patent 2,008,012,657
Patent Title: TRATAMIENTOS DE LAS ALERGIAS OCULARES. (OCULAR ALLERGY TREATMENTS.)

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

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 12, 2026
Generic Entry Controlled by: Mexico Patent 2,008,013,140
Patent Title: TRATAMIENTOS ANTIVIRALES INTRAMUSCULARES. (INTRAMUSCULAR ANTIVIRAL TREATMENTS.)

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

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

When can TYKERB (lapatinib ditosylate) generic drug versions launch?

Generic name: lapatinib ditosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 18, 2026
Generic Entry Controlled by: Mexico Patent 2,007,013,089
Patent Title: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)

TYKERB is a drug marketed by Novartis. There is one patent protecting this drug and one Paragraph IV challenge.

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

See drug price trends for TYKERB.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the lapatinib ditosylate profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Mexico Patent 2,008,013,958

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Mexico Patent 358,617

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Mexico Patent 384,206

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin 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

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 VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Mexico Patent 2,009,000,286
Patent Title: INHIBIDORES DE PROLIL HIDROXILASA Y METODOS DE USO. (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE.)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this generic product. Additional details are available on the vadadustat 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 eleven patents protecting this drug.

This drug has three hundred and forty-six 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 367,155

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

This drug has four hundred and fifty-one 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. Five 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 367,155

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

This drug has three hundred and thirteen 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 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 four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in twenty-five 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. Thirteen 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 sixty-eight patent family members in twenty-five 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. Thirteen suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide 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 sixty-eight patent family members in twenty-five 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. Thirteen suppliers are listed for this generic product. 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 sixty-eight patent family members in twenty-five 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. Thirteen suppliers are listed for this generic product. 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 2,009,001,853

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

This drug has one hundred and forty-seven patent family members in forty-four 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-five suppliers are listed for this generic product. Additional details are available on the ticagrelor 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 Genentech Inc. 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 INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: Mexico Patent 2,009,003,305
Patent Title: INHIBIDORES DE CO-TRANSPORTADOR DE GLUCOSA DE SODIO 2 Y METODO PARA SU USO. (PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2.)

Drug Price Trends for INPEFA
INPEFA is a drug marketed by Lexicon Pharms Inc. There are three patents protecting this drug.

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

See drug price trends for INPEFA.

The generic ingredient in INPEFA is sotagliflozin. One supplier is listed for this generic product. Additional details are available on the sotagliflozin 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 four patents protecting this drug.

This drug has one hundred and forty-five patent family members in forty-three 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-two 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 2,009,004,999
Patent Title: AMIDAS DE PEPTIDOS SINTETICOS Y DIMEROS DE LAS MISMAS. (SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF.)

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 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 Marinus. There are eleven patents protecting this drug.

This drug has forty-eight 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
Patent Title: SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETI L]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL. (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMIN O)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEE THANOL.)

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 KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Mexico Patent 2,008,008,298
Patent Title: SAL DE SULFATO DE HIDROGENO NOVEDOSA. (NOVEL HYDROGEN SULFATE SALT.)

KOSELUGO is a drug marketed by Astrazeneca. There are eight patents protecting this drug.

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

See drug price trends for KOSELUGO.

The generic ingredient in KOSELUGO is selumetinib sulfate. One supplier is listed for this generic product. Additional details are available on the selumetinib sulfate 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 AMELUZ (aminolevulinic acid hydrochloride) generic drug versions launch?

Generic name: aminolevulinic acid hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 22, 2026
Generic Entry Controlled by: Mexico Patent 2,009,006,088
Patent Title: NANOEMULSION. (NANOEMULSION.)

AMELUZ is a drug marketed by Biofrontera. There are three patents protecting this drug.

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

See drug price trends for AMELUZ.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the aminolevulinic acid hydrochloride profile page.

Last updated: December 24, 2025

xico Branded and Generic Drug Markets: Assessment, Regulatory Opportunities, and Challenges


Summary

Mexico’s pharmaceutical landscape is one of Latin America's most dynamic, characterized by rapid growth in its branded and generic drug segments. The market's evolution driven by an increasing burden of chronic illnesses, expanding healthcare coverage, and government reforms presents notable opportunities. However, regulatory complexities, price control policies, and intellectual property constraints pose challenges for pharmaceutical companies seeking to expand or innovate in this space. This analysis offers an in-depth assessment of Mexico’s pharmaceutical markets, emphasizing regulatory frameworks, market trends, competitive landscape, and strategic considerations for stakeholders.


Market Overview: Size and Growth Dynamics

Parameter Details Source
Total pharmaceutical market (2022) Approx. USD 10.2 billion (Mexican peso approx. MXN 200 billion) IMS Health (IQVIA), 2022
CAGR (2018-2022) ~4.5% annual growth IMS Health, 2022
Branded drugs market share ~70% of the total market Mexican FDA (COFEPRIS), 2022
Generic drugs market share ~30% of the total market IQVIA, 2022
Key growth segments Oncology, cardiology, diabetes, vaccines, antibiotics IMS Health, 2022

Key Drivers of Market Growth

  • Increasing chronic disease prevalence: Diabetes (12-14 million patients), hypertension, cancer rates rising annually.
  • Universal healthcare expansion: “INSABI” reforms expanding coverage to underserved populations.
  • Government procurement policies: Centralized purchasing via IFED, and tender processes fostering price competition.

Competitive Landscape

Players Market Share Strategies Notes
Pfizer, Novartis, Roche Top 10 players Product differentiation, R&D, partnerships Dominant in branded sector
Local companies (e.g., Liomont, Calox) Rising Cost-effective generics, local manufacturing Growing market share

Regulatory Environment: Key Frameworks and Processes

The Role of COFEPRIS

Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is responsible for drug registration, licensing, and regulatory oversight. Its framework aligns with international standards, with ongoing updates to streamline processes.

Drug Approval and Registration Processes

  • New chemical entities (NCEs): Submission of comprehensive dossiers including pre-clinical, clinical, manufacturing, and quality data. Approval times typically range from 6-12 months depending on complexity.
  • Generics: Simplified registration process; bioequivalence evidence sufficient. Priority given to registered reference products.
  • Market authorization fees: Ranged from USD 15,000-30,000, depending on product class and complexity (COFEPRIS, 2022).

Intellectual Property and Patent Policies

  • Patent duration: 20 years from filing. However, patent linkage and secondary patents are less rigorously enforced, opening opportunities for generic entry.
  • Compulsory licensing: Allowed in cases of public health necessity, especially during pandemics or crisis.

Price Controls and Reimbursement Policies

  • Price setting: The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) collaborates with Secretaría de Salud to regulate prices, especially for essential medicines.
  • Public tenders: Indigenous procurement agencies (e.g., IMSS, ISSSTE) conduct competitive tenders, favoring lower-cost generics.

Opportunities in Mexico’s Pharmaceutical Market

Growth Opportunities in Branded and Generic Segments

Opportunity Area Details Strategic Actions
Expansion of Generics Market Government policies favor generics to curb escalating public pharma costs Investment in local manufacturing, bioequivalence studies, and branding
Biopharmaceutical Innovation Growing demand for biosimilars and advanced therapies R&D investment, strategic licensing, partnership frameworks
Digital Transformation & Data Analytics Increasing use of AI and real-world evidence for regulatory and market insights Develop data-driven submission dossiers and post-market surveillance

Regulatory Advantages for Foreign Companies

  • Streamlined registration pathways for multinational companies with existing safety and efficacy data.
  • Participation in public tenders offering stable demand with competitive pricing pressures.
  • Potential for fast-tracking through mutual recognition agreements with U.S. and Europe.

Challenges Facing the Market

Regulatory Hurdles and Bureaucratic Delays

Issue Impact Mitigation Strategies
Lengthy registration times Delays market entry, increases costs Early engagement with COFEPRIS, local partnerships
Lack of harmonization with international standards Compliance complexity for global entities Alignment with ICH guidelines, local consultant engagement
Intellectual property constraints Limited patent enforcement, risk of patent cliffs Patent landscape analysis, licensing negotiations

Price Regulations and Market Access Barriers

Area Challenge Impact
Price caps on essential medicines Limits profit margins for innovative drugs Focus on cost-efficiency, value-based pricing strategies
Tendering process for public procurement Price sensitivity, aggressive bidding Differentiate through quality, biosimilars, and differentiated offerings

Supply Chain and Market Entry Barriers

  • Localization mandates: Encouraging local manufacturing but increasing compliance costs.
  • Distribution network complexities: Geographically diverse markets require robust logistics.
  • Regulatory data gaps: Especially in newer therapeutic areas, requiring strategic clinical development.

Comparative Analysis: Mexico vs. Other Latin American Markets

Parameter Mexico Brazil Argentina Chile
Market Size (USD billions) ~$10.2 (2022) ~$8.4 ~$3.5 ~$1.8
Regulatory Stringency Moderate Stringent Moderate Moderate
Price Regulation Extensive, government-controlled Price caps, reimbursement controls Price controls Price regulation
Patent Environment Less enforced, secondary patents common Strong patent enforcement Moderate enforcement Moderate enforcement

Implication: Mexico’s market offers unique combinations of growth opportunities with comparatively easier regulatory pathways but demands strategic navigation of price controls and local policies.


Key Regulatory Opportunities and Challenges

Opportunities Challenges
Rapid registration for generics and biosimilars Navigating bureaucratic delays and evolving standards
Government willingness to adopt innovative and high-value medicines Price controls restricting profit margins
Expansion of local manufacturing facilitated by government incentives Ensuring compliance with diverse regional and local regulations

Key Takeaways

  • Market Potential: The Mexican pharmaceutical market is poised for steady growth, driven by demographics and healthcare reforms, with a significant shift toward generics and biosimilars.
  • Regulatory Environment: While COFEPRIS offers accessible pathways for registration, complexities persist, requiring strategic planning and local expertise.
  • Competitive Edge: Multinational firms leveraging established pipelines and entering public tenders can capitalize on stability, but must adapt to price and local content policies.
  • Challenges: Regulatory delays, price regulation, and supply chain complexities demand proactive risk management and partnership strategies.
  • Strategic Focus: Investing in local manufacturing, aligning with government health priorities, and embracing digital tools for regulatory and market insights will position companies favorably.

FAQs

1. How long does the drug registration process typically take in Mexico?
The registration process for new drugs generally ranges from 6 to 12 months, contingent upon product complexity and dossier completeness [1]. Streamlining through early engagement with COFEPRIS and local partners can reduce timelines.

2. What are the key patent considerations for pharmaceutical companies in Mexico?
Mexico grants 20-year patents from filing but enforces secondary patents less rigorously. Patent linkage is limited, opening opportunities for generics, but firms must monitor patent landscapes closely to mitigate infringement risks [2].

3. Can foreign pharmaceutical companies participate effectively in Mexico’s public tenders?
Yes, multinational firms regularly participate in public procurement, especially when offering proven products at competitive prices. Strategies include local manufacturing, biosimilar development, and leveraging existing regulatory approvals in other jurisdictions.

4. What role does price regulation play in shaping Mexico’s pharmaceutical market?
The government actively sets price caps on essential medicines, affecting profit margins and investment strategies. Companies often respond with cost-efficiency measures or focus on higher-value therapeutic products to offset margins.

5. How does Mexico compare with other Latin American markets regarding regulatory challenges?
Compared to Brazil's stringent regulations and Argentina's price controls, Mexico offers a relatively more predictable and faster regulatory process for registered medicines, making it an attractive entry point for firms targeting Latin America [3].


References

[1] COFEPRIS. (2022). Pharmaceutical Registration Processes.
[2] World Intellectual Property Organization (WIPO). (2022). Patent Landscape in Mexico.
[3] IQVIA. (2022). Latin American Pharmaceutical Market Report.


In conclusion, Mexico’s pharmaceutical industry presents promising opportunities amid regulatory complexities. Success hinges on strategic alignment with government policies, investment in local manufacturing, and agility in navigating evolving regulations. Entities that master these dynamics will secure a competitive advantage in this vibrant market.

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