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Last Updated: April 22, 2025

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African Regional IP Organization (ARIPO): These 3 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "African Regional IP Organization (ARIPO): These 3 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 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: African Regional IP Organization (ARIPO) Patent 2,406
Patent Title: Macrocydic inhibitors of hepatitis C virus.

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 ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
Generic Entry Controlled by: African Regional IP Organization (ARIPO) Patent 2,655
Patent Title: 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-four 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-three suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: African Regional IP Organization (ARIPO) Patent 3,071
Patent Title: Ganaxolone formulations and methods for the makingand use thereof

ZTALMY is a drug marketed by Marinus. There are nine patents protecting this drug.

This drug has forty-five patent family members in sixteen countries.

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.

Market Analysis and Financial Projection

The African Regional Intellectual Property Organization (ARIPO) plays a pivotal role in shaping pharmaceutical market dynamics across 19 member states, with significant implications for both branded and generic drug accessibility. Here's an analysis of the regulatory landscape and its market impacts:


Market Assessment

Branded Generics Growth Potential

The global branded generics market is projected to grow at a 5.7% CAGR, reaching $375.95B by 2030[1][6]. In Africa, this growth faces unique barriers:

  • Patent evergreening: ARIPO grants multiple patents for minor drug modifications (e.g., new formulations), blocking generic competition[3][10].
  • Legal conflicts: 12 ARIPO members are Least Developed Countries (LDCs) entitled to waive pharmaceutical patents until 2033 under TRIPS, but ARIPO continues granting patents in these jurisdictions[8][10].

Generic Drug Barriers

  • Excessive patent grants: 25% of ARIPO applications are pharmaceutical, with a 33% approval rate across most member states[14].
  • Lack of safeguards: No formal opposition mechanism exists to challenge frivolous patents[3][8].

Regulatory Challenges

Patent Law Misalignment

  • Conflict with national laws: Uganda’s Industrial Property Act (2014) prohibits pharma patents until 2033, yet ARIPO grants patents that override this[8].
  • Weak examination standards: ARIPO’s lax patentability assessments enable evergreening strategies[3][10].

TRIPS Flexibility Gaps

Issue Impact
No LDC waiver implementation Undermines domestic generic production in 12 LDC member states[8][10]
Limited compulsory licensing Restricts affordable medicine access during health crises[4][7]
Absence of regional opposition Prevents third-party challenges to weak patents[3][5]

Strategic Opportunities

Policy Reforms

  1. Harare Protocol amendments: Align ARIPO practices with TRIPS flexibilities and national health priorities[5][7].
  2. Public health patent guidelines: Introduce rigorous examination criteria to prevent unjustified monopolies[5][10].
  3. Regional opposition mechanisms: Enable pre/post-grant patent challenges[5][8].

Economic Leverage

  • Local manufacturing boost: Implementing LDC waivers could save $1B annually through generic substitution in ARIPO states[11].
  • Cost reduction potential: Generic competition lowers prices by 80-95% compared to originator drugs[6][12].

Case Study: East African Community (EAC)

The EAC’s 2012 Pharmaceutical Manufacturing Plan emphasizes TRIPS flexibilities to:

  • Increase generic production capacity
  • Reduce import dependency (currently >70% of medicines)[7][9] However, ARIPO’s current patent practices contradict these goals by granting 113 pharmaceutical patents in Uganda alone between 2017-2020[11].

Key Insight:

"ARIPO’s patent regime acts as a de facto trade barrier, privileging multinational patent holders over regional health priorities" [7][9].


Path Forward

  1. Legislative harmonization: Make ARIPO patents optional rather than automatic in member states[8][14].
  2. Capacity building: Train examiners in public health-oriented patent assessment[5][13].
  3. Data transparency: Publish pharmaceutical patent databases to inform generic market entry[11][12].

The resolution of ARIPO’s regulatory contradictions could unlock $2.3B in annual savings through expanded generic access across its membership[1][6], while supporting WHO’s goal of 60% local medicine production by 2030[4][7].

References

  1. https://www.grandviewresearch.com/industry-analysis/branded-generics-market
  2. https://www.southcentre.int/wp-content/uploads/2014/11/RP56_The-ARIPO-Protocol-on-Patents_ENRev.pdf
  3. https://healthgap.org/press/almost-100-organisations-demand-reform-of-african-regional-patent-office-aripo-to-improve-access-to-medicines/
  4. https://pubmed.ncbi.nlm.nih.gov/33706726/
  5. https://www.kelinkenya.org/wp-content/uploads/2019/06/CSO_TRIPSFlexibilitiesProposalsForARIPOFinal-with-sign-ons-4-6-19.pdf
  6. https://www.drugpatentwatch.com/blog/branded-generics-what-they-are-and-why-theyre-profitable/
  7. https://infojustice.org/archives/33607
  8. https://www.cehurd.org/regional-pharmaceutical-patents-continue-to-hinder-access-to-medicines-in-uganda/
  9. https://www.southcentre.int/wp-content/uploads/2014/11/RP56_The-ARIPO-Protocol-on-Patents_ENl.pdf
  10. https://healthgap.org/press/over-60-health-organisations-demand-aripo-reform-to-increase-access-to-more-affordable-medicines-in-eastern-southern-africa/
  11. https://makemedicinesaffordable.org/wp-content/uploads/2021/03/DESIGNED-TRIPs-REPORT-2020.pdf
  12. https://www.alliedmarketresearch.com/branded-generics-market-A10537
  13. https://www.lynchllp.com/blog/aripo-intellectual-property-in-africa
  14. https://inventa.com/en/news/article/446/patents-referred-to-medicaments-in-the-context-of-the-aripo-and-its-contracting-states

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