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

Argentina: These 27 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Argentina: These 27 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 KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Argentina Patent 58,696
Patent Title: SAL DE SULFATO DE HIDROGENO DEL ACIDO 6-(4-BROMO-2-CLORO-FENILAMINO)-7-FLUOR-3-METIL-3H-BENZOIMIDAZOL-5-CARBOXILICO.

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 BELRAPZO (bendamustine hydrochloride) generic drug versions launch?

Generic name: bendamustine hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: January 13, 2026
Generic Entry Controlled by: Argentina Patent 52,877
Patent Title: COMPOSICIONES FARMACEUTICAS DE BENDAMUSTINA

BELRAPZO is a drug marketed by Eagle Pharms. There are eleven patents protecting this drug. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for BELRAPZO.

The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the bendamustine hydrochloride profile page.

When can BENDEKA (bendamustine hydrochloride) generic drug versions launch?

BENDEKA is a drug marketed by Eagle Pharms. There are twenty patents protecting this drug and one Paragraph IV challenge. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for BENDEKA.

The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the bendamustine hydrochloride profile page.

When can WAKIX (pitolisant hydrochloride) generic drug versions launch?

Generic name: pitolisant hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 08, 2026
Generic Entry Controlled by: Argentina Patent 54,734
Patent Title: COMPUESTO QUE COMPRENDE MONOCLORHIDRATO DE 1-[3-[3(4-CLOROFENIL) PROPOXI] PROPIL] - PIPERIDINA CRISTALINO, PROCEDIMIENTO PARA SU FABRICACION Y COMPOSICIONES FARMACEUTICAS.

WAKIX is a drug marketed by Harmony. There are three patents protecting this drug.

This drug has sixty-one patent family members in thirty-one countries. There has been litigation on patents covering WAKIX

See drug price trends for WAKIX.

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

When can CORLANOR (ivabradine) generic drug versions launch?

Generic name: ivabradine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: Argentina Patent 52,926
Patent Title: FORMA CRISTALINA GAMA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES QUE LA CONTIENEN

CORLANOR is a drug marketed by Amgen Inc. There are eight patents protecting this drug.

This drug has ninety-seven patent family members in forty-two countries. There has been litigation on patents covering CORLANOR

See drug price trends for CORLANOR.

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

When can CORLANOR (ivabradine hydrochloride) generic drug versions launch?

Generic name: ivabradine hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: Argentina Patent 53,147
Patent Title: FORMA CRISTALINA DEL CLORHIDRATO DE IVABRADINA, UN PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICIONES FARMACEUTICAS QUE LA CONTIENEN

CORLANOR is a drug marketed by Amgen Inc. There are eight patents protecting this drug.

This drug has ninety-seven patent family members in forty-two countries. There has been litigation on patents covering CORLANOR

See drug price trends for CORLANOR.

The generic ingredient in CORLANOR is ivabradine hydrochloride. There are nine drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the ivabradine hydrochloride profile page.

When can NEXAVAR (sorafenib tosylate) generic drug versions launch?

Generic name: sorafenib tosylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 03, 2026
Generic Entry Controlled by: Argentina Patent 54,234
Patent Title: COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL CANCER

NEXAVAR is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in thirty-nine countries. There has been litigation on patents covering NEXAVAR

See drug price trends for NEXAVAR.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the sorafenib tosylate profile page.

When can ACTOPLUS MET XR (metformin hydrochloride; pioglitazone hydrochloride) generic drug versions launch?

Generic name: metformin hydrochloride; pioglitazone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 15, 2026
Generic Entry Controlled by: Argentina Patent 54,238
Patent Title: COMPOSICION FARMACEUTICA QUE CONTIENE UNA BIGUANIDA Y UN DERIVADO DE TIAZOLIDINDIONA

ACTOPLUS MET XR is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in twenty-five countries. There has been litigation on patents covering ACTOPLUS MET XR

See drug price trends for ACTOPLUS MET XR.

The generic ingredient in ACTOPLUS MET XR is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride 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: Argentina Patent 60,278
Patent Title: TRATAMIENTOS DE LAS ALERGIAS OCULARES

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 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: Argentina Patent 54,252
Patent Title: COMPOSICION FARMACEUTICA ORAL QUE CONTIENE SALES DE DITOSILATO DE 4-QUINAZOLINAMINA

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 XCOPRI (cenobamate) generic drug versions launch?

Generic name: cenobamate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2026
Generic Entry Controlled by: Argentina Patent 53,065
Patent Title: COMPUESTOS AZOLICOS NEUROTERAPEUTICOS Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN

XCOPRI is a drug marketed by Sk Life. There are two patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has twenty-six patent family members in twenty countries. There has been litigation on patents covering XCOPRI

See drug price trends for XCOPRI.

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

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 24, 2026
Generic Entry Controlled by: Argentina Patent 55,917
Patent Title: PROCESO DE REDUCCION CATALITICA ASIMETRICA PARA PREPARAR LOS ISOMEROS (S)-(+) Y (R)-(-) DEL COMPUESTO (10,11-DIHIDRO-10-HIDROXI-5-H DIBENZ [B.F] AZEPIN-5-CARBOXAMIDA]

APTIOM is a drug marketed by Sumitomo Pharma Am. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred patent family members in twenty-six countries. There has been litigation on patents covering APTIOM

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate 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: Argentina Patent 60,755

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: Argentina Patent 79,930

When can VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: May 31, 2026
Generic Entry Controlled by: Argentina Patent 55,198
Patent Title: FORMULACIONES FARMACEUTICAS Y METODOS DE TRATAMIENTO QUE LAS UTILIZAN

VICTRELIS is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.

This drug has twenty-seven patent family members in seventeen countries.

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

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: Argentina Patent 61,297

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 TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Argentina Patent 61,481
Patent Title: COMPUESTOS CON ACTIVIDAD COMBINADA SOBRE SERT, 5-HT3 Y 5-HT1A

TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two 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 TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Argentina Patent 65,797
Patent Title: USOS Y DERIVADOS DE 1-(2- (2,4- DIMETILFENILSULFANIL) FENIL) PIPERAZINA

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: Argentina Patent 61,565

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: Argentina Patent 61,627

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: Argentina Patent 61,730

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: Argentina Patent 61,730

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: Argentina Patent 61,730

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 BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 29, 2026
Generic Entry Controlled by: Argentina Patent 54,505
Patent Title: FORMAS CRISTALINAS DE 4- ((2,4-DICLORO-5-METOXIFENIL) AMINO ) -6-METOXI-7-(3-(4-METIL-1-PIPERAZINIL) PROPOXI) -3- QUINOLINCARBONITRILO Y METODOS DE PREPARACION DE LAS MISMAS

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.

This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF

See drug price trends for BOSULIF.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate profile page.

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 28, 2026
Generic Entry Controlled by: Argentina Patent 55,359
Patent Title: INHIBIDORES MACROCICLICOS DEL VIRUS DE LA HEPATITIS C

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

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

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

When can REVLIMID (lenalidomide) generic drug versions launch?

Generic name: lenalidomide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Argentina Patent 57,868
Patent Title: METODOS EN LOS QUE SE USA 3-(4-AMINO-1-OXO-1,3-DIHIDRO-ISOINDOL-2-IL)-PIPERIDIN-2,6-DIONA PARA EL TRATAMIENTO DE CIERTAS LEUCEMIAS

REVLIMID is a drug marketed by Bristol Myers Squibb. There are two patents protecting this drug and three Paragraph IV challenges.

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

See drug price trends for REVLIMID.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this API. Fifteen suppliers are listed for this generic product. Additional details are available on the lenalidomide 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 07, 2026
Generic Entry Controlled by: Argentina Patent 57,882
Patent Title: COMPUESTOS DE ACCION DOBLE DE BLOQUEADORES DEL RECEPTOR DE ANGIOTENSINA E INHIBIDORES DE ENDOPEPTIDASA NEUTRA

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 XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Argentina Patent 57,964

XALKORI is a drug marketed by Pf Prism Cv. There are five patents protecting this drug.

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

See drug price trends for XALKORI.

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

When can AVANDAMET (metformin hydrochloride; rosiglitazone maleate) generic drug versions launch?

Generic name: metformin hydrochloride; rosiglitazone maleate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Argentina Patent 57,970
Patent Title: COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE LA DIABETES MELLITUS Y CONDICIONES ASOCIADAS CON LA DIABETES MELLITUS Y PROCEDIMIENTOS PARA PREPRAR DICHAS COMPOSICIONES

AVANDAMET is a drug marketed by Sb Pharmco.

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

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this API. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

Last updated: July 27, 2025

Introduction

Argentina's pharmaceutical sector stands as one of Latin America's most significant markets, characterized by a growing demand for both branded and generic pharmaceuticals. The country's economic dynamics, regulatory landscape, and healthcare infrastructure shape opportunities and challenges for industry stakeholders. As Argentina navigates economic fluctuations and evolving health policies, understanding its market segmentation and regulatory environment becomes critical for pharmaceutical companies aiming to expand or invest.

Market Overview

Pharmaceutical Market Size and Segmentation

Argentina’s pharmaceutical market, valued at approximately USD 4.4 billion in 2022, demonstrates steady growth driven by an aging population, increasing prevalence of chronic diseases, and government health initiatives. The market comprises two primary segments:

Branded Pharmaceuticals: These account for roughly 55-60% of sales, often representing innovative, patented drugs with high R&D investments. Multinational corporations dominate this segment, leveraging brand recognition and patent protections.
Generic Pharmaceuticals: Making up approximately 40-45% of the market, generics play an essential role in providing cost-effective alternatives. The government actively promotes generics to contain healthcare costs and improve access.

Market Drivers and Trends

Key factors influencing growth include government policies favoring generics, expanding insurance coverage, and increasing healthcare expenditure. Additionally, the COVID-19 pandemic underscored the need for robust pharmaceutical supply chains and local manufacturing capabilities.

Regulatory Landscape

Regulatory Agencies and Frameworks

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) functions as Argentina's primary regulatory authority, overseeing drug registration, quality control, and market surveillance. Regulatory requirements aim to ensure drug safety, efficacy, and quality, aligning with international standards such as WHO guidelines.

Drug Registration and Approval

The registration process involves comprehensive submission dossiers demonstrating safety, efficacy, and manufacturing quality. Speed and transparency of approval can vary; recent reforms seek to streamline processes, especially for generics.

Pricing and Reimbursement Policies

Argentina employs a price control mechanism managed by the Precios Máximos system, which sets maximum prices for medications, including generics. Reimbursement strategies are managed through the National Institute of Social Services (ANSES) and private insurers, emphasizing cost containment.

Intellectual Property Rights

Patent protection adheres to international standards, though generic entry is facilitated post-patent expiry. Compulsory licensing and patent flexibilities are permitted under specific circumstances, aligned with World Trade Organization (WTO) obligations.

Opportunities in the Argentine Market

Growing Demand for Generics

The government's push to expand generic use presents opportunities for manufacturers willing to navigate regulatory processes. The promotion of bioequivalent generics enhances market acceptance, especially among cost-conscious healthcare providers and patients.

Local Manufacturing and Supply Chain Development

Investment in local production facilities can mitigate import dependencies, reduce costs, and align with government incentives aimed at self-sufficiency. The expansion of manufacturing capabilities is aligned with the country's strategic health priorities.

Innovative and Biosimilar Drugs

While the focus remains on generics, there is rising interest in biosimilars and innovative therapies. Companies capable of navigating complex regulatory pathways for biosimilars may find competitive advantages.

Digital Health Integration

Emerging trends in digital health and telemedicine open avenues for pharmaceutical companies to engage with healthcare providers and patients digitally, enhancing market penetration.

Challenges Facing the Argentine Pharmaceutical Sector

Economic Instability and Currency Fluctuations

High inflation, currency devaluation, and economic uncertainty pose risks for pricing strategies and profitability. Regulatory approvals may be delayed due to resource limitations or political factors.

Regulatory Barriers and Bureaucracy

Despite reforms, procedural delays and bureaucratic hurdles persist, especially in drug registration and price adjustments. Navigating local regulatory requirements demands specialized expertise.

Price Regulation and Market Access

Stringent price controls limit profit margins, necessitating efficient cost management. Reimbursement restrictions can hinder the commercial success of new and innovative drugs.

Intellectual Property Limitations

While protections are aligned with international standards, enforcement challenges and potential for compulsory licensing can impact market exclusivity for innovative drugs.

Market Competition

The presence of well-established multinational corporations and local generics manufacturers intensifies competition, requiring strategic differentiation and compliance to standards.

Regulatory Opportunities for Industry Stakeholders

Participating in Regulatory Reforms

Active engagement with ANMAT and policymakers can influence future regulatory frameworks, facilitating faster approvals and clarity in procedures.

Leveraging Public-Private Partnerships

Collaborations with government agencies can unlock incentives, streamline registration, and ensure compliance with local standards.

Advancing Biosimilar and Biotech Approvals

Investing in biosimilar registration prepares companies for future market segments, aligning with global industry trends and regional demands.

Promoting Local Manufacturing and R&D

Supporting the development of local R&D centers and manufacturing plants can qualify for fiscal incentives, tax breaks, and preferential policies.

Conclusion

Argentina presents a nuanced landscape where economic, regulatory, and market factors intertwine. While opportunities abound—particularly within generics, biosimilars, and local manufacturing—stakeholders must navigate significant challenges related to price controls, economic volatility, and regulatory complexity. Strategic engagement, compliance with evolving regulations, and adaptation to local market dynamics are essential for sustained success.

Key Takeaways

Argentina's pharmaceutical market offers lucrative opportunities in generics, biosimilars, and local manufacturing, driven by government policies promoting cost containment and access.
Regulatory engagement with ANMAT and understanding price control mechanisms are critical for market entry and sustained operations.
Economic volatility necessitates flexible pricing strategies and risk management approaches.
Investment in local R&D and manufacturing aligns with government incentives and supports market resilience.
Companies should prioritize transparency, compliance, and strategic partnerships to effectively navigate Argentina’s regulatory and market landscape.

FAQs

What is the current regulatory approval process for new pharmaceuticals in Argentina?
Approval involves comprehensive dossier submission to ANMAT, demonstrating safety, efficacy, and manufacturing quality. The process has been streamlined recently but can still vary in duration based on drug complexity and compliance.
How does Argentina's pricing regulation impact pharmaceutical profitability?
Maximum price controls, especially for essential medicines, can limit profit margins. Companies need effective cost strategies and may seek reimbursement agreements to mitigate these impacts.
Are there incentives for foreign pharmaceutical companies to establish local manufacturing in Argentina?
Yes, the government offers incentives such as tax exemptions, grants, and preferential treatment for local manufacturing, especially in high-priority sectors like biosimilars and innovative medicines.
What are the main challenges in registering biosimilars in Argentina?
Biosimilar registration requires extensive comparative data to demonstrate equivalence, adherence to complex regulatory standards, and navigating evolving guidelines, which can be resource-intensive.
How do intellectual property rights affect market entry and competition?
Patents generally protect innovative drugs for a standard period; however, exceptions such as compulsory licensing can impact exclusivity. Generics can enter post-patent expiry, increasing competition.

Sources:

[1] AOAC International, "Argentina Pharmaceutical Market Overview," 2022.
[2] ANMAT Official Website, "Regulatory Guidelines," 2023.
[3] Oxford Economics, "Healthcare and Pharmaceutical Market Trends in Latin America," 2022.
[4] World Trade Organization, "Trade-Related Aspects of Intellectual Property Rights," 2021.
[5] IQVIA, "Argentina Pharma Market Report," 2022.