You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 24, 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

➤ Get the Full List

Argentina: These 12 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Generic Entry Dates in Other Countries

African Regional IP Organization (ARIPO) Australia Austria Brazil Canada Chile China Colombia Costa Rica Croatia Cuba Cyprus Denmark Dominican Republic Ecuador El Salvador Eurasian Patent Organization European Patent Office Finland France Georgia, Republic of Germany Guatemala Honduras Hong Kong Hungary Israel Japan Jordan Lithuania Luxembourg Malaysia Mexico Montenegro Morocco Netherlands New Zealand Nicaragua Norway Panama Peru Philippines Poland Portugal Russian Federation San Marino Saudi Arabia Serbia Singapore Slovenia South Africa South Korea Spain Taiwan Tunisia Turkey Ukraine United Kingdom United States Uruguay World Intellectual Property Organization (WIPO)
Preferred citation:
Friedman, Yali, "Argentina: These 12 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
Media collateral
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 TYKERB (lapatinib ditosylate) generic drug versions launch?

Generic name: lapatinib ditosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 19, 2025
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 22, 2025
Generic Entry Controlled by: Argentina Patent 53,065

Drug Price Trends for XCOPRI
XCOPRI is a drug marketed by Sk Life. There are two patents protecting this drug.

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

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 VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 02, 2025
Generic Entry Controlled by: Argentina Patent 55,198

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 BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2025
Generic Entry Controlled by: Argentina Patent 54,505

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges.

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 APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
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]

Drug Price Trends for APTIOM
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. Two suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

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

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
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 OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Argentina Patent 99,345
Patent Title: INHIBIDORES MACROCÍCLICOS DEL VIRUS DE LA HEPATITIS C, COMPOSICIONES FARMACÉUTICAS QUE LOS COMPRENDEN, USO DE LOS MISMOS Y PROCESO PARA PREPARARLOS

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 LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Argentina Patent 58,175
Patent Title: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-six suppliers are listed for this generic product. Additional details are available on the pregabalin 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 09, 2025
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 twenty-eight patent family members in forty countries. There has been litigation on patents covering ENTRESTO SPRINKLE

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan 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 09, 2025
Generic Entry Controlled by: Argentina Patent 106,613
Patent Title: [HEMI-PENTAHIDRATO DE [3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOXI-CARBONIL-1-BUTIL-CARBAMOIL)-PROPIONATO-(S)-3 -METIL-2 -(PENTANOIL-{2 -(TETRAZOL-5-ILATO)-BIFENIL-4 -ILMETIL}-AMINO)-BUTIRATO] DE TRISODIO

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan 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 09, 2025
Generic Entry Controlled by: Argentina Patent 106,614
Patent Title: COMPUESTOS ORGÁNICOS

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine 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 05, 2025
Generic Entry Controlled by: Argentina Patent 57,964
Patent Title: POLIMORFOS DE UN INHIBIDOR DE C-MET/HGFR

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 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 five patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four countries.

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 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

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 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 111,697
Patent Title: COMPOSICIÓN OFTÁLMICA PARA EL TRATAMIENTO DE LAS ALERGIAS OCULARES

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 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

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

This drug has four hundred and sixty-two 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

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

This drug has four hundred and sixty-two 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.

Market Analysis and Financial Projection

The Argentine pharmaceutical market presents a dynamic interplay between branded and generic drugs, shaped by regulatory frameworks, economic pressures, and shifting demographics. Below is a detailed analysis of the market dynamics, regulatory environment, and opportunities and challenges.

Market Overview

Branded vs. Generic Drug Share

  • Generic drugs account for ~45% of Argentina’s pharmaceutical market, driven by affordability and government promotion of non-proprietary names in prescriptions[7][13].
  • Branded generics dominate due to strong physician and consumer loyalty, with pure generics representing only 10% of sales[16]. Many prescriptions still include both generic and brand names, reinforcing brand preference[16].

Growth Drivers

  1. Aging Population:
    Argentina’s elderly population is projected to rise from 10% (2020) to 15% (2050), driving demand for chronic disease management and cost-effective generics[1].
  2. Patent Expirations:
    Patents expire after 20 years with no extensions, enabling rapid generic entry. Notable examples include drugs for diabetes and hypertension[1][7].
  3. Economic Pressures:
    Inflation (115% in 2023) and austerity policies have reduced overall drug sales by 39% YoY in early 2024, favoring cheaper generics[4][7].

Key Players

  • Domestic firms like Laboratorios Bagó, Elea Laboratories, and Gador S.A. control 71% of local production[10][13].
  • Multinationals such as Novartis and Pfizer rely on partnerships with local labs due to regulatory requirements[15][16].

Regulatory Landscape

Opportunities

  1. ANMAT’s Harmonization Efforts:
    Argentina’s regulatory authority (ANMAT) aligns with WHO/PAHO standards, simplifying approvals for products from "Annex I" countries (e.g., U.S., EU)[9].

    • E-prescribing: Digitization of prescriptions has improved generic accessibility[9].
    • Flexible Bioequivalence standards support local generic production[9].

  2. Pro-Generic Policies:

    • Mandatory use of International Nonproprietary Names (INN) in public sector prescriptions[6].
    • Subsidies for local manufacturing reduce import dependency[7][13].

Challenges

  1. Economic Instability:
    Currency devaluation and inflation have disrupted supply chains, with pharmaceutical imports projected to drop to 6.5% of GDP in 2024[4][12].

  2. Intellectual Property Weaknesses:

    • Limited patent protection and frequent counterfeit drug issues (10% of medicines in the region)[7][15].
    • Regulatory data protection gaps deter innovation-focused multinationals[5][15].

  3. Bureaucratic Delays:

    • Product registrations take 12+ months despite a legally mandated 90-day window[15].
    • Inconsistent regional regulations under AMLAC (Latin American Medicines Agency) prolong market entry[6][7].

Strategic Insights

Market Entry Considerations

  • Foreign companies must partner with local entities to register products[15].
  • Joint ventures and co-marketing agreements are common due to domestic labs’ distribution advantages[16].

Future Trends

  • Local Production Expansion:
    Domestic labs increasingly invest in biosimilars and complex generics to address chronic diseases[13].
  • AMLAC Harmonization:
    Regional regulatory alignment could streamline approvals but requires stronger IP enforcement[6][7].

Key Takeaways

Factor Impact
Aging Population Boosts demand for generics in chronic care (e.g., diabetes, hypertension).
ANMAT’s Annex I Policy Accelerates approvals for U.S./EU-derived drugs.
Inflation & Austerity Favors generics but pressures R&D investment.
Weak IP Protections Limits innovation but supports generic competition.

FAQs

  1. Why are branded generics dominant in Argentina?
    Physicians often include brand names in prescriptions, and consumers associate brands with quality[16].

  2. How does ANMAT streamline generic approvals?
    By accepting bioequivalence data from Annex I countries and prioritizing local manufacturing[9].

  3. What risks do foreign firms face?
    Currency volatility, delayed payments, and mandatory local partnerships[4][15].

  4. How prevalent are counterfeit drugs?
    ~10% of medicines in Argentina are counterfeit, undermining trust in generics[7].

  5. What role does AMLAC play?
    It aims to harmonize regulations across Latin America but remains a work in progress[6][7].

“Argentina’s generic drug market thrives on affordability, but economic headwinds and regulatory complexities demand strategic agility.” – TechSci Research[1][7]

References

  1. https://www.techsciresearch.com/report/argentina-generic-drugs-market/15613.html
  2. https://www.imarcgroup.com/latin-america-generic-drug-market
  3. https://pharmaboardroom.com/legal-reports/the-pharma-legal-handbook-argentina/
  4. https://www.fitchsolutions.com/bmi/pharmaceuticals/argentine-drug-sales-under-pressure-amid-escalating-prices-12-03-2024
  5. https://www.businesswire.com/news/home/20220415005058/en/Argentina-Pharmaceutical-and-Healthcare-Industry-Forecast-and-Analysis-2022-Featuring-Profiles-of-Laboratorios-Bago-GlaxoSmithKline-Merck-Co-Novartis-Pfizer-and-Sanofi---ResearchAndMarkets.com
  6. https://www.drugpatentwatch.com/blog/regulatory-challenges-in-the-latin-american-generic-drug-market/
  7. https://www.marketdataforecast.com/market-reports/latin-america-generic-drugs-market
  8. https://www.grandviewresearch.com/horizon/outlook/pharmaceutical-regulatory-affairs-market/argentina
  9. https://tannerpharma.com/wp-content/uploads/2022/10/LAC-A-Guide-to-the-Key-Pharma-Markets-in-LATAM.pdf
  10. https://www.languageconnections.com/blog/argentinas-pharmaceutical-market-gbi-executive-summary-report/
  11. https://www.freyrsolutions.com/global/regulatory-services-in-argentina
  12. https://www.genengnews.com/insights/small-latin-american-countries-think-big/
  13. https://cilfa.org.ar/wp1/wp-content/uploads/2021/08/Escenario-y-Perspectivas-de-la-Industria-Farmaceutica-Argentina-Ingles-2021.pdf
  14. https://ghmcnetwork.com/wp-content/uploads/2022/03/GHMC_GlobalGuide_MarketAccess_2022.pdf
  15. https://www.indembarg.gov.in/content/Pharmaceutical-Sector-in-Argentina-2024.pdf
  16. https://www.pharmexec.com/view/country-report-argentina

More… ↓

⤷  Try for Free

DrugPatentWatch cited by CNN, NEJM, Nature Journals, and more …

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links

Follow DrugPatentWatch:

  DrugPatentWatch Linkedin Group