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Last Updated: April 19, 2025

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France: These 6 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "France: These 6 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 LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: France Patent 14C0069

Drug Price Trends for LATUDA
LATUDA is a drug marketed by Sunovion Pharms Inc. There are seven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has fifty-eight patent family members in twenty-three countries. There has been litigation on patents covering LATUDA

See drug price trends for LATUDA.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this API. Thirty suppliers are listed for this generic product. Additional details are available on the lurasidone hydrochloride 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: France Patent 16C0018

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: France Patent 21C1000

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 ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: France Patent 24C1004

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.

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: France Patent 21C1051

KOSELUGO is a drug marketed by Astrazeneca. There are six 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 PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: France Patent 2,897,866
Patent Title: FORME CRISTALLINE ALPHA DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (New alpha crystalline form of perindopril arginine salt are angiotensin I converting enzyme inhibitor, useful for the manufacture of drugs to treat cardiovascular diseases)

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine 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: France Patent 13C0034

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.

Market Analysis and Financial Projection

The French pharmaceutical market is undergoing significant transformation, balancing cost containment pressures with innovation demands. Here's a detailed analysis of the branded and generic drug sectors, along with regulatory opportunities and challenges:

Market Overview

  • Generic Drugs:
    Valued at $21.22B in 2022, the market is projected to grow at 6.81% CAGR through 2028[1][2]. Generics account for ~35% of reimbursed drugs by volume[15], driven by:

    • Rising chronic diseases (cardiovascular, diabetes)[2]
    • Government initiatives (e.g., mandatory INN prescriptions)[4][6]
    • Cost savings of €1.2B/year from generics[16]
  • Branded Drugs:
    Face intensifying competition from generics and biosimilars, with price erosion due to:

    • PLFSS 2024 reforms: Stricter price negotiations and safeguards[3][9]
    • Healthcare sovereignty push: "Made in Europe" labeling pressures imports[11][18]

Regulatory Opportunities

For Generics:

  1. Biosimilar Expansion:
    Biosimilars (generic biologics) are the fastest-growing segment, with ranibizumab ophthalmology biosimilars recently approved[3]. ANSM projects biosimilars to drive hospital drug sales growth of 19.3% CAGR through 2029[12].

  2. Orphan Drug Development:
    New policies incentivize generics for rare diseases, addressing 3,000+ untreated conditions[2].

  3. Digital Pharmacy Integration:
    Online pharmacies (projected 15% market share by 2025[5]) enable wider generic distribution.

For Branded Drugs:

  1. Innovation Incentives:
    PLFSS 2024 reduces clawback taxes for novel therapies meeting unmet needs (e.g., hemophilia B gene therapy HEMGENIX)[9].

  2. Niche Therapeutics:
    France’s aging population drives demand for neurology/oncology innovations. Hospital drug sales for patented products grow at 6.3% CAGR[12].

  3. Reshoring Support:
    €500M allocated to reduce API import dependency (currently 80% from Asia)[7][18].


Regulatory Challenges

For Generics:

  1. Market Saturation:
    Price erosion (2.8% CAGR growth vs 6.81% value growth[8]) due to 1,000+ generic groups competing[4].

  2. Substitution Limits:
    Only 22% of drugs are substitutable under the Generics Repertory[16], restricting volume growth.

  3. Quality Concerns:
    15% of EU drug shortages originate in France[9], prompting stricter ANSM oversight[13].

For Branded Drugs:

  1. Pricing Pressures:
    CEPS caps prices using Germany/UK benchmarks, with avg. 30% discount vs U.S. prices[17].

  2. HTA Complexity:
    HAS requires comparative effectiveness data, extending approval timelines by 6-12 months[6][14].

  3. Prescription Monitoring:
    Doctors prescribing above regional averages face penalties (€50M fines levied in 2023)[3][6].


Strategic Comparison

Aspect Generics Branded Drugs
Growth Driver Biosimilars (+19.3% CAGR)[12] Orphan drugs (+36.4% CAGR)[10]
Pricing Pressure 6.81% value CAGR vs 1.3% volume[1] PLFSS 2024 clawback reductions[9]
Regulatory Focus Substitution rate targets (40%[16]) "Made in Europe" labeling[11]

Future Outlook

France’s pharmaceutical spending will reach €53.8B by 2029[12], with three key trends:

  1. Biosimilar Dominance: Projected 22.6% hospital market share by 2029[12].
  2. EU-Localized Production: API reshoring targets 50% capacity by 2030[18].
  3. Digital Integration: 70% of pharmacies to offer teleconsultations by 2027[5].

"Generics overturn the values and rules that structured our healthcare system for 40 years, reflecting its singular evolution." – Cogito, Sciences Po[15]

Pharma companies must balance cost containment (generic substitution quotas) with innovation investments (orphan drug incentives) to thrive under France’s evolving regulatory regime.

References

  1. https://www.techsciresearch.com/report/france-generic-drugs-market/20159.html
  2. https://www.techsciresearch.com/news/14866-france-generic-drugs-market.html
  3. https://www.hoganlovells.com/en/publications/increasing-financial-regulation-of-the-pharmaceutical-sector-by-the-french-government
  4. https://gabi-journal.net/wp-content/uploads/GJ-2015-3-p136-140-Perspective-Rottembourg.pdf
  5. https://www.statista.com/outlook/hmo/pharmacies/france
  6. https://www.pharmtech.com/view/market-access-outlook-france
  7. https://atradius.us/knowledge-and-research/reports/pharmaceuticals-industry-trends-france---2022
  8. https://www.researchandmarkets.com/reports/5650961/france-generics-market-summary-competitive
  9. https://trinitylifesciences.com/blog/rise-with-the-waves-france-accelerating-pricing-and-market-access-two-policies-shaping-pharmas-future/
  10. https://smart-pharma.com/wp-content/uploads/2019/08/French-Pharma-Market-2020-2025-Excerpts-FV.pdf
  11. https://www.politico.eu/article/france-made-in-europe-labels-drugs/
  12. https://smart-pharma.com/wp-content/uploads/2025/01/French-Pharma-Market-2024-2029-Excerpts.pdf
  13. https://omcmedical.com/france-drug-product-registration/
  14. https://pmc.ncbi.nlm.nih.gov/articles/PMC4865760/
  15. https://www.sciencespo.fr/research/cogito/home/how-generic-drugs-have-changed-our-healthcare-system/?lang=en
  16. https://www.pharmexec.com/view/country-reports-france-french-pharma-revolution
  17. https://openyls.law.yale.edu/bitstream/handle/20.500.13051/18129/Kesselheim%20et%20al,%20Why%20France%20Spends%20Less%20Than%20the%20United%20States%20on%20Drugs-%20A%20Comparative%20Study%20of%20Drug%20Pricing%20and%20Pricing%20Regulation.pdf?sequence=1&isAllowed=y
  18. https://www.fitchsolutions.com/bmi/pharmaceuticals/drugmakers-will-face-regulatory-scrutiny-and-economic-pressures-amid-pharmaceutical-reshoring-france-11-11-2024

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