Elafibranor - Generic Drug Details

What are the generic drug sources for elafibranor and what is the scope of freedom to operate?

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 thirty-nine patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for elafibranor

International Patents:	39
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
Patent Applications:	1,897
What excipients (inactive ingredients) are in elafibranor?	elafibranor excipients list
DailyMed Link:	elafibranor at DailyMed

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.

Recent Clinical Trials for elafibranor

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayo Clinic	PHASE2
Ipsen	PHASE3
Ipsen	Phase 3

See all elafibranor clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for elafibranor

A05AX	Other drugs for bile therapy
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

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	12,295,928
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
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	11,857,523

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
South Korea	102338085
Eurasian Patent Organization	038386	СПОСОБЫ ЛЕЧЕНИЯ ХОЛЕСТАТИЧЕСКИХ ЗАБОЛЕВАНИЙ (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)
China	109152756	胆汁淤积性疾病的治疗方法 (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)
Japan	7010836
Israel	311687	שיטות לטיפול במחלות עימדון מרה (Methods of treatment of cholestatic diseases)

Supplementary Protection Certificates for elafibranor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3435996	C20250032	Finland
3435996	CA 2025 00035	Denmark		PRODUCT NAME: ELAFIBRANOR AND PHARMACEUTICALLY ACCEPTABLE SALTS AND ESTERS THEREOF; REG. NO/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	PA2025535	Lithuania		PRODUCT NAME: ELAFIBRANORAS; REGISTRATION NO/DATE: EU/1/24/1855 20240919

Market Dynamics and Financial Trajectory for Elafibranor

Last updated: July 27, 2025

Introduction

Elafibranor (formerly GFT505) is an innovative dual peroxisome proliferator-activated receptor (PPAR) alpha/delta agonist developed primarily for the treatment of non-alcoholic steatohepatitis (NASH) and related metabolic disorders. As the global burden of NASH escalates, driven by obesity, type 2 diabetes, and metabolic syndrome, pharmaceutical companies are intensifying efforts to bring effective therapies to market. Elafibranor, once a promising candidate, exemplifies the complexities of drug development, regulatory hurdles, and market entry in a competitive landscape. This analysis outlines the key market dynamics shaping elafibranor’s trajectory and examines the financial implications of its development.

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Market Landscape for NASH Therapeutics

NASH remains an area of high unmet medical need, with an estimated 16 million Americans affected [1]. Its progression from simple steatosis to fibrosis, cirrhosis, and hepatocellular carcinoma underscores the urgency for efficacious treatments. The absence of FDA-approved pharmacotherapies reinforces opportunities for innovative agents, including PPAR agonists like elafibranor.

Multiple players are vying in this therapeutics landscape, with intercept Pharmaceuticals' obeticholic acid, Genfit's elafibranor, and emerging biotech candidates leading early-stage development. The market’s dynamics are influenced by factors such as:

• Regulatory environments: Stricter endpoints and surrogate markers have increased hurdles for approval.
• Clinical trial results: Efficacy in reversing fibrosis and improving NASH resolution determines investment and positioning.
• Competitive pipeline: Larger pharmaceutical firms like Gilead Sciences, Novartis, and Pfizer are exploring or developing NASH agents, constraining market share for early entrants.

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Elafibranor’s Clinical Development and Regulatory Status

Elafibranor gained significant attention following positive phase 2b trial results demonstrating improvements in liver inflammation and fibrosis markers [2]. However, the drug faced setbacks, notably a failed phase 3 trial announced in 2020 due to insufficient efficacy in reaching primary endpoints [3].

The regulatory landscape has concurrently evolved, with agencies such as the FDA emphasizing histological improvement and fibrosis regression as primary endpoints. The failure to meet these endpoints delayed or obstructed approval pathways for elafibranor, diminishing its prospects versus competitors with better clinical data.

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Market Dynamics Impacting Elafibranor

1. Regulatory Hurdles
   A key driver influencing elafibranor’s future is the stringent regulatory framework. The need for clear, demonstrable benefits, particularly fibrosis improvement—a surrogate biomarker—is critical. The recent failure in phase 3 trials illustrates how unmet endpoints can jeopardize approval prospects, reducing investor confidence and market competitiveness.

2. Competitive Pressure
   The progress of alternative compounds, particularly resmetirom (MGL-3196) by Madrigal Pharmaceuticals and isherotene (RDX002), places increasing pressure on elafibranor. Market entry of drugs with superior efficacy profiles or better safety margins diminishes elafibranor’s potential market share, especially if further development is halted or delayed.

3. Market Size and Unmet Need
   While the overall NASH market is projected to reach USD 21.5 billion by 2027 [4], the subset of patients suitable for elafibranor is influenced by regulatory approval, market penetration strategies, and physician adoption. Delays or failures in obtaining approval significantly impact the commercial viability.

4. Strategic Partnerships and Licensing
   GFI (Genfit), the developer of elafibranor, has explored collaborations for licensing or co-development. The adequacy of such partnerships directly influences development costs, market entry strategy, and financial sustainability.

5. Pricing and Reimbursement
   Given the complex efficacy and safety landscape, pricing strategies for elafibranor would rely on demonstrating significant clinical benefits. Payer skepticism towards high-cost therapies without robust long-term data could impede reimbursement, affecting revenue projections.

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Financial Trajectory and Investment Outlook

The financial trajectory of elafibranor hinges heavily on its clinical success and regulatory approval process. The recent phase 3 failure significantly alters its investment profile, with implications including:

• Increased R&D costs: Further trials or reformulation may be necessary to salvage the development program.
• Decreased valuation: The market generally discounts assets with failed pivotal trials; previous valuations for genfit's pipeline have sharply declined.
• Strategic pivoting: Genfit may seek to repurpose elafibranor for other indications such as cardiovascular or metabolic disorders, diversifying its commercial prospects.

Historically, drug development costs for NASH agents have exceeded USD 1 billion [5], with the probability of approval after phase 2 trials estimated at approximately 10-15%. Given the setbacks, elafibranor’s near-term financial outlook is cautionary.

Potential Revenue Streams

Should elafibranor eventually gain approval, revenue would depend on:

• Market penetration rates
• Pricing strategies aligned with clinical benefits
• Competitive landscape and emergent alternative therapies

The delayed or halted development reduces imminent revenue expectations, shifting the financial outlook to long-term scenarios contingent on potential reformulation or new clinical data.

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Market Entry and Growth Opportunities

Despite setbacks, several pathways could influence elafibranor’s future:

• Regulatory re-engagement: Submission of additional data or real-world evidence might meet regulators' expectations.
• Pipeline diversification: Developing elafibranor for other conditions, such as diabetic dyslipidemia or cardiovascular disease, may offset NASH-specific setbacks.
• Strategic mergers or licensing agreements: Larger pharma or biotech firms may acquire rights, injecting capital and accelerating development.

Investment Considerations

Investors should closely monitor:

• The status of ongoing or planned trials for alternative indications.
• Regulatory feedback and potential pathways for reapplication.
• Industry announcements regarding strategic partnerships or divestments.

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Key Takeaways

• Elafibranor’s promising early clinical results have been overshadowed by recent phase 3 trial failures, impacting its market viability.
• The evolving regulatory landscape emphasizes fibrosis and histological endpoints, increasing demands on drug developers.
• Competitive pressures from other NASH therapies and emerging candidates diminish elafibranor’s market share prospects.
• Financially, the drug faces significant hurdles, including increased R&D costs, reduced valuation, and uncertain reimbursement prospects.
• Future opportunities depend on strategic repositioning, partnership acquisition, or re-engagement with regulators, though these entail considerable uncertainty.

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FAQs

1. What is elafibranor’s primary mechanism of action?
   Elafibranor is a dual PPAR-alpha/delta agonist that modulates lipid metabolism, inflammation, and fibrogenesis, targeting key pathways in NASH pathophysiology [2].

2. Why did elafibranor fail in phase 3 trials?
   The trials did not meet primary endpoints related to NASH resolution and fibrosis improvement, possibly due to insufficient efficacy or issues with trial design and patient selection [3].

3. Can elafibranor be repurposed for other indications?
   Yes, potential exists for exploring elafibranor in metabolic syndrome, cardiovascular diseases, or other inflammatory conditions, depending on ongoing research and regulatory approval considerations.

4. What are the main competitors in the NASH therapeutic space?
   Key competitors include intercept’s obeticholic acid, Madrigal’s resmetirom, and Novartis’ ongoing candidates, all aiming for regulatory approval with robust clinical data.

5. What strategic options remain for genfit regarding elafibranor?
   Genfit may seek licensing or partnership deals, pursue reformulation or additional trials, or pivot toward other metabolic or cardiovascular indications to salvage the asset.

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References

[1] Younossi, Z. et al. (2019). Global epidemiology of nonalcoholic fatty liver disease—Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology, 70(4), 1457-1466.

[2] Fournier, P. et al. (2014). GFT505, a dual agonist of PPARα and δ, improves lipid and glucose parameters in preclinical models. Hepatology, 60(4), 1244-1254.

[3] Genfit (2020). Genfit announces results of Phase 3 trial of elafibranor in NASH. Company Press Release.

[4] Grand View Research (2021). NASH Market Size, Share & Trends Analysis.

[5] DiMasi, J.A., Grabowski, H.G., & Hansen, R.W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20-33.