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Last Updated: December 15, 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 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 fifty-eight 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 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-one 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.

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

Last updated: July 27, 2025

Introduction

Mexico represents one of Latin America's most significant pharmaceutical markets, characterized by rapid growth, substantial demand for branded and generic drugs, and evolving regulatory frameworks. As a burgeoning hub for pharmaceutical innovation and access, understanding the market dynamics, regulatory landscape, and associated opportunities and risks is crucial for stakeholders seeking strategic entry or expansion within the country. This report explores the current market environment, regulatory complexities, opportunities, and challenges faced by pharmaceutical companies operating in or targeting Mexico’s drug sector.

Market Overview

Market Size and Growth Dynamics

Mexico's pharmaceutical market is valued at approximately USD 7.9 billion as of 2022, with an expected compound annual growth rate (CAGR) of 4-6% through 2025 [1]. This growth is driven by factors such as an aging population, increasing prevalence of chronic diseases, improved healthcare access, and government initiatives promoting local manufacturing.

Brand vs. Generic Drug Market Share

Branded drugs currently dominate Mexico's pharmaceutical sales, accounting for roughly 70-75%, primarily due to established patent protections and strong marketing efforts. However, the generic segment is expanding rapidly, representing approximately 25-30% of the market, fueled by government policies promoting cost-effective treatment options and increased healthcare expenditure efficiency [2].

Market Drivers and Challenges

Key market drivers include:

  • Government efforts to promote affordable medicines through biosimilars and generics.
  • Rising health insurance coverage, expanding patient access.
  • Growing domestic pharmaceutical manufacturing capabilities.

Challenges encompass:

  • Price regulation pressures.
  • Market fragmentation.
  • Limited patent enforcement clarity.

Regulatory Landscape

Regulatory Bodies and Frameworks

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) governs pharmaceutical registration, approval, and surveillance in Mexico. Its regulatory framework aligns with international standards, incorporating comprehensive drug registration processes, pharmacovigilance, and quality controls [3].

Drug Registration and Approval Process

To market a drug in Mexico, companies must submit comprehensive dossiers, including preclinical, clinical, manufacturing, and labeling information. The approval process typically takes between 6 to 12 months, with expedited pathways available for certain essential medicines and generics.

Intellectual Property and Patent Regulations

Mexico's patent system aligns with the World Trade Organization’s TRIPS Agreement. However, challenges persist regarding patent enforcement, leading to patent expirations that open opportunities for generic manufacturers. Recent legal disputes over patent rights and data exclusivity influence market entry timing for branded drugs.

Pricing and Reimbursement Policies

Mexico employs a government-controlled pricing model, with the Secretaría de Salud setting maximum retail prices (MRPs) for many medicines. Reimbursement schemes increasingly favor generics, encouraging substitution at pharmacies, which impacts branded drug positioning.

Biologics and Biosimilars Regulations

Regulatory pathways for biosimilars are emerging, with guidelines that demand demonstration of biosimilarity in quality, efficacy, and safety. The approval of biosimilars offers opportunities for cost reduction but requires significant clinical development investment.

Opportunities in the Market

Expansion of Generics and Biosimilars

Patent expirations provide fertile ground for generic and biosimilar entrants. Strategic partnerships with local manufacturers enhance market access, given Mexico’s policies favoring domestic production [4].

Local Manufacturing Incentives

Government initiatives such as the "National Development Plan" aim to promote local pharmaceutical manufacturing, offering incentives like tax breaks, subsidies, and streamlined registration processes to companies that establish or expand production facilities.

Digital and Innovative Health Solutions

The COVID-19 pandemic accelerated telemedicine and digital health adoption. Companies integrating digital solutions for drug delivery, adherence, and pharmacovigilance can capitalize on this trend.

Public-Private Partnerships (PPPs)

Engaging in PPPs with government agencies allows pharmaceutical firms to participate in national health programs, vaccine initiatives, and disease-specific campaigns, broadening market reach.

Regulatory Navigation and Local Partnerships

Establishing strategic alliances with local regulatory consultants and distributors enhances compliance efficiency, market penetration, and understanding of regional nuances.

Challenges in the Market

Pricing Pressures and Reimbursement Restrictions

Stringent price controls and reimbursement caps limit profit margins, especially for branded medicines. The government’s emphasis on cost containment necessitates innovative pricing strategies and value demonstration.

Intellectual Property Enforcement

Weak patent enforcement may lead to legal disputes, counterfeit risks, and market erosion of patented products. Navigating IP rights requires specialized legal expertise.

Regulatory Complexity and Delays

The approval process can be protracted due to bureaucratic hurdles, gaps in regulatory clarity, and resource constraints within COFEPRIS. Delays threaten timely market entry and alignment with global timelines.

Market Fragmentation and Competition

The presence of numerous local and international players increases competition, exerting price pressure and necessitating differentiated value propositions.

Regulatory Uncertainty for Biosimilars

Despite emerging guidelines, biosimilar regulations require further standardization. Lack of clear pathways can deter investment in biosimilar development.

Regulatory Opportunities

Policy Reforms Favoring Generics and Biosimilars

Recent government policies aim to accelerate the approval and adoption of cost-effective medicines, offering pathways for expedited registration of generics and biosimilars under certain conditions.

Open Access to Data and Transparency Initiatives

COFEPRIS is progressively increasing transparency around technical requirements and approval statuses, facilitating smoother submission processes.

Incentivization for Local Production

Tax incentives, streamlined licensing, and support for technology transfer foster local manufacturing, aligning with government objectives to reduce import dependency.

Strategic Use of Mutual Recognition Agreements

Mexico’s participation in regional trade agreements can facilitate faster approvals for companies holding registered medicines in partner economies, reducing time-to-market.

Expansion of Digital Regulatory Submissions

Adoption of electronic submission portals improves efficiency, transparency, and traceability, aligning with global e-regulatory trends.

Market Challenges and Strategies

Overcoming Price and Reimbursement Barriers

Engaging with policymakers to demonstrate the clinical and economic value of innovative therapies can influence favorable reimbursement policies. Emphasizing health economics and real-world evidence enhances negotiation power.

Strengthening Patent and IP Strategies

Robust IP portfolios and early patent filings are critical to protect market exclusivity. Collaborating with local legal experts helps navigate patent challenges.

Building Local Relationships and Alliances

Establishing partnerships with domestic regulatory authorities, local manufacturers, and healthcare providers fosters trust, accelerates market access, and mitigates bureaucratic obstacles.

Capacity Building in Regulatory Compliance

Investing in regulatory affairs capabilities ensures ongoing compliance and quicker adaptation to policy changes, reducing approval timelines.

Conclusion

Mexico’s pharmaceutical market presents a compelling landscape for branded and generic drug manufacturers, supported by growing demand, local manufacturing incentives, and evolving regulatory frameworks. While opportunities related to biosimilars, generics, and local partnerships are promising, navigating complex regulations, price controls, and IP challenges requires strategic planning. Companies that proactively align their market entry strategies with Mexico’s regulatory reforms, local policies, and health priorities are better positioned to capitalize on this dynamic environment.

Key Takeaways

  • Mexico’s pharmaceutical market is expanding, with generics and biosimilars gaining prominence due to patent expirations and government policies.
  • Regulatory pathways are improving but still present delays; early engagement with COFEPRIS and local partners enhances success probability.
  • Local manufacturing incentives and partnership opportunities are key drivers for market penetration.
  • Price regulation and reimbursement restrictions necessitate value-based marketing and strategic negotiation.
  • Strengthening patent and IP strategies is essential to safeguard innovations amid enforcement challenges.

FAQs

  1. What are the primary regulatory bodies overseeing drug registration in Mexico?
    The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the main regulatory authority responsible for drug registration, approval, and surveillance [3].

  2. How does Mexico promote the use of generic drugs?
    Mexico encourages generics through policies such as mandatory substitution at pharmacies, price controls, and reimbursement schemes favoring cost-effective therapies, especially in public healthcare programs [2].

  3. What opportunities exist for biosimilars in Mexico?
    As biosimilar regulations develop, they offer opportunities to introduce cost-effective biologic therapies. Companies must comply with emerging guidelines that demand demonstration of biosimilarity and safety [4].

  4. What are the main challenges faced by pharmaceutical companies in Mexico?
    Challenges include price regulation, regulatory delays, weak patent enforcement, market fragmentation, and navigating complex approval processes.

  5. How can companies effectively navigate Mexico’s pharmaceutical regulatory environment?
    Engaging local regulatory consultants, building relationships with authorities, investing in compliance capabilities, and understanding policy updates are crucial for successful market entry and ongoing operations.


References

[1] IQVIA: Mexico Pharmaceutical Market Report, 2022.
[2] IMS Health: Trends and Forecasts in Mexico's Pharmaceutical Sector, 2021.
[3] COFEPRIS: Regulatory Guidelines for Pharmaceuticals, 2022.
[4] WHO: Biosimilar Medicines in Mexico: Regulatory Developments, 2022.

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