elafibranor - Profile

What are the generic sources for elafibranor and what is the scope of patent protection?

Elafibranor is the generic ingredient in one branded drug marketed by Ipsen and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elafibranor has forty-three patent family members in thirty countries.

Summary for elafibranor

International Patents:	43
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for elafibranor

Constraining patent/regulatory exclusivity:

TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for elafibranor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	11,857,523
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	11,850,223
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	11,331,292
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	11,185,519
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	12,310,935
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	12,295,928
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	12,295,927

Expired US Patents for elafibranor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024	7,632,870
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024	7,943,661

International Patents for elafibranor

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4559481	MÉTHODES DE TRAITEMENT DE MALADIES CHOLESTATIQUES (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)
Croatia	P20250776
Eurasian Patent Organization	038386
Lithuania	3435996
European Patent Office	3435996	MÉTHODES DE TRAITEMENT DE MALADIES CHOLESTATIQUES (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)
Canada	3018132
Mexico	2018011738	METODOS DE TRATAMIENTO DE ENFERMEDADES COLESTATICAS. (METHODS OF TREATMENT OF CHOLESTATIC DISEASES.)

Supplementary Protection Certificates for elafibranor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3435996	PA2025535	Lithuania		PRODUCT NAME: ELAFIBRANORAS; REGISTRATION NO/DATE: EU/1/24/1855 20240919
3435996	50008/2025	Austria		PRODUCT NAME: ELAFIBRANOR UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/24/1855 (MITTEILUNG) 20240923
3435996	CA 2025 00035	Denmark		PRODUCT NAME: ELAFIBRANOR AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF; REG. NO/DATE: EU/1/24/1855 20240923
3435996	LUC50022	Luxembourg		PRODUCT NAME: ELAFIBRANOR ET UN DE SES SELS OU ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1855 20240923
3435996	301342	Netherlands		PRODUCT NAME: ELAFIBRANOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1855 20240923
3435996	2025C/542	Belgium		PRODUCT NAME: ELAFIBRANOR ET UN DE SES SELS OU ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1855 20240923
3435996	122025000050	Germany		PRODUCT NAME: ELAFIBRANOR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1855 20240919

Investment Scenario and Fundamentals Analysis for Elafibranor

Last updated: February 20, 2026

Elafibranor (formerly GFT505) is a drug developed by Genfit targeting metabolic and liver diseases, primarily non-alcoholic steatohepatitis (NASH). Its development life cycle, clinical efficacy, and market landscape influence investment prospects.

Clinical Development and Regulatory Status

Elafibranor is a dual peroxisome proliferator-activated receptor alpha/delta (PPAR α/δ) modulator aimed at NASH, fibrosis, and related metabolic conditions. The drug completed Phase 2 trials with promising results but has yet to secure FDA or EMA approval.

• Phase 2b data (2018): Showed histological improvements in liver fat content and fibrosis scores.
• Regulatory pathway: The company has pursued a special protocol assessment with the FDA, but no formal approval has been granted as of Q1 2023.

Market Landscape

NASH is a high-priority indication with an estimated global market valuation at approximately $6.3 billion in 2022, forecasted to grow at 11.3% through 2030 ([1]). No drugs have received full FDA approval; the pipeline includes several late-stage candidates, such as:

• Intercept Pharma's obeticholic acid (OCA)
• Novo Nordisk's semaglutide
• Genfit's elafibranor

Elafibranor's competitive position hinges on clinical efficacy, safety profile, regulatory status, and its differentiation from existing candidates.

Financial and Investment Fundamentals

• Funding and partnerships: In 2019, Genfit secured €30 million in Series D funding, focusing on late-stage trials. The company also entered licensing agreements with partners in Asia.
• Market capitalization (as of Q1 2023): Approx. €250 million.
• Commercial prospects: Potential approval could unlock a multi-billion-dollar market, contingent on successful Phase 3 outcomes and regulatory approval.

Risks and Considerations

• Clinical efficacy uncertainties: While Phase 2b showed promise, Phase 3 results are pending and critical.
• Regulatory hurdles: NASH drugs face complex approval pathways due to histological endpoints and safety concerns.
• Competitive landscape: Other companies' drugs, particularly semaglutide from Novo Nordisk, exhibit promising efficacy, pressuring elafibranor's potential market share.
• Financial viability: Current revenues derive from partnerships; no commercial sales have commenced.

Investment Outlook

Elafibranor's value depends on successfulPhase 3 trial outcomes, regulatory approval, and eventual commercialization. The unresolved clinical and regulatory uncertainties suggest high risk with potential high reward if development progresses favorably.

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Key Takeaways

• Elafibranor targets NASH with a Phase 2b that demonstrates histological improvements.
• The drug's future hinges on Phase 3 trial success and regulatory approval, which have not yet occurred.
• The broader NASH market presents substantial growth potential, but competition is intensifying.
• Financial metrics indicate a speculative investment, with potential upside if trials succeed and the drug enters the market.
• Risks include clinical setback, regulatory delays, and market competition from established and emerging therapies.

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FAQs

1. What is the current regulatory status of elafibranor?
Elafibranor has completed Phase 2b trials; no full approval has been granted. The company's regulatory submissions and discussions are ongoing, with Phase 3 trials not yet completed.

2. How does elafibranor compare to other NASH drugs in development?
In terms of clinical data, elafibranor has shown fibrosis and steatosis improvements in Phase 2b. Competing drugs like semaglutide demonstrate significant weight loss and liver fat reduction, but elafibranor's PPAR modulation offers a different mechanism.

3. What are major risks for investors considering elafibranor?
Core risks include failure in Phase 3 trials, delays or rejection by regulators, and intense competition. Clinical efficacy and safety concerns remain critical.

4. What is the potential market size for elafibranor if approved?
The global NASH market is projected to reach $11 billion by 2030 ([1]). Elafibranor's addressable market depends on label scope, specifically fibrosis and NASH resolution.

5. What financial indicators suggest the viability of investment?
Genfit's market capitalization (~€250 million) reflects developmental risk. No revenue is generated; valuation is driven by potential approval and commercialization success.

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References

[1] Grandview Research. (2022). Non-Alcoholic Steatohepatitis Market Size, Share & Trends. [2] Genfit. (2023). Corporate Presentation and Clinical Data.