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

Last Updated: April 28, 2025

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

➤ Get the Full List

Costa Rica: These 8 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

Preferred citation:
Friedman, Yali, "Costa Rica: These 8 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 OMONTYS (peginesatide acetate) generic drug versions launch?

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 03, 2025
Generic Entry Controlled by: Costa Rica Patent 9,570
Patent Title: FORMULACIONES Y USOS DEL PEPTIDO RECEPTOR DE ERITROPOYETINA

OMONTYS is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

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

The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Costa Rica Patent 11,259
Patent Title: BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPUETICAS

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Costa Rica Patent 9,609
Patent Title: FORMULACIONES DE UNA SAL DE BUPROPION DE LIBERACION MODIFICADA

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide 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: Costa Rica Patent 9,596
Patent Title: FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y METODOS PARA SU PREPARACION

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 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: Costa Rica Patent 9,783
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 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: Costa Rica Patent 9,950
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-five suppliers are listed for this generic product. Additional details are available on the pregabalin 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: Costa Rica Patent 10,329
Patent Title: DERIVADOS DE ESTIRILPIRIDINA Y SUS USOS PARA UNION A PLACAS AMILOIDES Y OBTENCION DE IMAGENES DE LAS MISMAS

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.

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: Costa Rica Patent 10,414
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 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: Costa Rica Patent 10,440
Patent Title: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-YL)ETIL]AMINO]METIL]FENIL]2E-2-PROPENAMIDA

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.

Market Analysis and Financial Projection

Costa Rica's pharmaceutical market presents a dynamic landscape for both branded and generic drugs, shaped by evolving regulations, economic growth, and public health priorities. Here’s an analysis of market trends and regulatory dynamics:


Market Overview

Branded Drug Market

  • Growth Drivers: Costa Rica’s $483.8M prescription drug market (2024–2025) benefits from rising chronic disease rates (e.g., diabetes, hypertension) and an aging population[1][7]. Branded drugs retain demand among private healthcare users seeking faster access than public systems provide[5][7].
  • Challenges: Price controls are under discussion, potentially limiting profit margins for patented medicines[7]. Public reliance on the Caja Costarricense de Seguro Social (CCSS) reduces branded drug adoption due to cost sensitivity[1].

Generic Drug Market

  • Expansion: Generics dominate ~34% of Costa Rica’s domestic pharmaceutical market, supported by cost-saving policies and a 2021 decree mandating prescriptions by International Nonproprietary Names (INN)[11]. Regional projections show Latin America’s generic market growing at 6.41% CAGR to $69B by 2033[2][6].
  • Competitive Edge: Local manufacturers export generics to Ecuador (126 registered products in 2022) and benefit from bilateral agreements like COMISCA[8][13].

Regulatory Opportunities

  1. Harmonized Regional Standards
    Adoption of the RTCA 11.03.59:18 streamlines drug approvals across Central America. Costa Rica now accepts mutual registrations, reducing redundancies for multi-country market entry[3][14].
    Example: Panama aligns with RTCA, easing Costa Rican exports[3].

  2. Pro-Generic Policies

    • Mandatory INN prescriptions in private healthcare (Decree 43233-S) boost generic substitution[11].
    • Public-sector reliance on generics (via CCSS) drives ~70% market penetration, mirroring Brazil’s success[1][2].
  3. Manufacturing & Export Growth
    Costa Rica’s pharmaceutical sector leverages:

    • GMP Compliance: High-quality production attracts multinationals like Teva and Sandoz[13].
    • Strategic Location: Proximity to North/South American markets supports export-driven growth[8][13].
  4. AMLAC Harmonization
    The Latin American Medicines Agency aims to unify regulations, simplifying approvals and post-market surveillance for generics[6][14].


Regulatory Challenges

  1. Bureaucratic Delays

    • Drug registrations take 6–12 months due to understaffed agencies and paperwork bottlenecks[14].
    • Post-authorization changes (e.g., manufacturer swaps) require resubmission, risking supply disruptions[10].
  2. Price Controls & Reimbursement
    Public healthcare’s fixed pricing pressures margins, while private insurers prioritize cost-effective generics[5][7]. Ecuador’s import price caps complicate export strategies[8].

  3. Synthetic Drug Oversight
    Lack of frameworks for new psychoactive substances (NPS) and synthetic opioids creates regulatory gaps, increasing diversion risks[9].

  4. Regional Fragmentation
    Despite RTCA, countries like Nicaragua exclude third-party packaging rules, complicating regional compliance[3][14].


Strategic Recommendations

  • Leverage INN Mandates: Generic manufacturers should emphasize bioequivalence testing to meet CCSS procurement criteria[11][13].
  • Adopt AMLAC Early: Align with emerging regional standards to expedite approvals[6].
  • Invest in Local Production: Costa Rica’s manufacturing infrastructure offers cost advantages for generics targeting Latin American markets[8][13].

Key Insight: Costa Rica’s generic sector thrives on policy tailwinds, but slower approvals and pricing pressures demand agile partnerships. Branded drugs face niche demand in private healthcare, requiring targeted patient access programs[1][7].

Citations: [1][2][3][5][6][7][8][9][10][11][13][14]

References

  1. https://www.statista.com/outlook/hmo/pharmacies/prescription-drugs/costa-rica
  2. https://www.marketdataforecast.com/market-reports/latin-america-generic-drugs-market
  3. https://latinalliance.co/en/2022/01/19/nuevo-rtca-de-medicamentos/
  4. https://home.treasury.gov/news/press-releases/jy1911
  5. https://www.coldwellbankersamara.com/article/healthcare-system-in-costa-rica-what-retirees-need-to-know
  6. https://www.drugpatentwatch.com/blog/regulatory-challenges-in-the-latin-american-generic-drug-market/
  7. https://store.fitchsolutions.com/pharmaceuticals-healthcare/costa-rica-pharmaceuticals-report
  8. https://www.procomer.com/news/exporter-new/pharmaceutical-sector-of-costa-rica-has-the-potential-to-expand-exports-to-ecuador/?lang=en
  9. https://www.oas.org/ext/en/main/oas/our-structure/gs/sms/cicad/multilateral-evaluation-mechanism/Publications/moduleId/12676/id/609/lang/1/controller/Item/action/Download
  10. https://ispe.org/pharmaceutical-engineering/may-june-2023/cmc-requirements-new-drug-registration-latin-america
  11. https://gabionline.net/guidelines/decree-signed-in-costa-rica-for-the-use-of-generic-name-in-medicines
  12. https://www.oecd.org/content/dam/oecd/en/topics/policy-sub-issues/structural-reforms/country-tailored-policy-reforms/583170-CHL_OECD_policy_actions_affordable_and_accessible_pharmaceuticals.pdf
  13. https://www.thecentralamericangroup.com/costa-rican-pharmaceutical-manufacturing/
  14. https://trade.ec.europa.eu/access-to-markets/en/country-assets/28%2008%2023%20Technical%20Barriers%20to%20Pharmaceutical%20products%20in%20CA_fv.pdf

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.