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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Elafibranor has eighty patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for elafibranor

International Patents:	80
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
Patent Applications:	567
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
Ipsen	Phase 3
Ipsen	Phase 2
Ipsen	Phase 1

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			Y
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
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			Y	Y
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

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
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024

International Patents for elafibranor

Country	Patent Number	Title	Estimated Expiration
China	109152756	胆汁淤积性疾病的治疗方法 (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)
Spain	2287529
Portugal	1525177
Israel	261935	שיטות לטיפול במחלות עימדון מרה (Methods of treatment of cholestatic diseases)
Norway	20045301
Poland	207362
Norway	329700

Elafibranor Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Elafibranor

Introduction to Elafibranor

Elafibranor, a drug candidate developed by GENFIT, is poised to make a significant impact in the treatment of Primary Biliary Cholangitis (PBC) and other liver diseases. Here, we delve into the market dynamics and financial trajectory of this promising therapeutic agent.

Primary Biliary Cholangitis (PBC) Market Overview

PBC is a chronic, cholestatic, autoimmune liver disease characterized by high unmet medical needs despite the availability of current therapies. The market for PBC treatments is substantial, with estimates suggesting it will reach $1.5 billion annually by 2035[1][4].

Market Opportunity for Elafibranor

Elafibranor is being positioned as a second-line treatment for patients with PBC who cannot benefit from first-line therapies. Market research conducted by IQVIA indicates that elafibranor could achieve peak sales of $515 million in 2035, capturing a significant share of the PBC market[1][4].

Patient Population and Market Penetration

It is estimated that up to 90,000 patients could be treated with elafibranor by 2030 if it receives regulatory approval. The research model, based on conservative assumptions, predicts market penetration of approximately 32% in the United States and 22% in the European Union by 2035[1][4].

Differentiated Profile of Elafibranor

Elafibranor is distinguished by its strong safety, efficacy, and improvement in pruritus (itching), a common symptom in PBC patients. This differentiated profile is supported by robust research involving 28 Key Opinion Leaders (KOLs), 240 healthcare professionals, and 15 US and EU payors[1][4].

Regulatory and Commercial Pathway

The regulatory pathway for PBC treatments is well-defined, and payors and KOLs have a clear understanding of the disease. This clarity is expected to facilitate the approval and adoption of elafibranor. GENFIT has partnered with Ipsen for the commercial launch of elafibranor, which includes milestone payments and royalty revenues[2][4].

Financial Projections and Milestones

GENFIT anticipates significant financial milestones related to elafibranor. These include a €48.7 million milestone payment from Ipsen in June 2024 and an additional €0.9 million in royalty revenue from US sales of elafibranor. These revenues are expected to support GENFIT's operating expenses and capital expenditure requirements until the fourth quarter of 2025[2].

Revenue and Net Loss

As of 2023, GENFIT reported a revenue of €15.2 million, up from €12.5 million in 2022. Despite increasing revenues, the company incurred a net loss of €39.0 million in 2023, reflecting ongoing research and development expenses. The R&D expenses have been steadily increasing, from €20.1 million in 2021 to €30.0 million in 2023[5].

Strategic Goals and Expansion

GENFIT's strategic goals include advancing the clinical development of elafibranor for treating Non-Alcoholic Steatohepatitis (NASH), expanding partnerships to enhance research capabilities, leveraging biomarker discovery for improved diagnostics and treatment, and growing its global market presence in liver disease therapeutics[5].

Biomarker Discovery and Diagnostic Improvements

Biomarker discovery is a critical component of GENFIT's strategy, aimed at improving diagnostics and treatment outcomes for liver diseases. This approach could further differentiate elafibranor and enhance its market position by providing more precise and effective treatment options[5].

Global Market Presence

GENFIT is focused on expanding its global market presence, particularly in the liver disease therapeutics sector. With elafibranor poised for regulatory approval and commercial launch, the company is well-positioned to capitalize on the growing demand for effective liver disease treatments[5].

Key Takeaways

• Market Size: The PBC market is estimated to reach $1.5 billion annually by 2035.
• Peak Sales: Elafibranor could achieve $515 million in peak sales as a second-line treatment.
• Patient Population: Up to 90,000 patients could be treated with elafibranor by 2030.
• Differentiated Profile: Elafibranor offers strong safety, efficacy, and improvement in pruritus.
• Financial Projections: Significant milestone payments and royalty revenues are anticipated.
• Strategic Goals: GENFIT is focused on advancing clinical development, expanding partnerships, and growing global market presence.

FAQs

Q: What is the estimated market size for PBC treatments by 2035?

A: The PBC market is estimated to reach $1.5 billion annually by 2035[1][4].

Q: How much could elafibranor achieve in peak sales as a second-line treatment for PBC?

A: Elafibranor could achieve $515 million in peak sales as a second-line treatment for PBC[1][4].

Q: What is the estimated patient population that could be treated with elafibranor by 2030?

A: Up to 90,000 patients could be treated with elafibranor by 2030 if it receives regulatory approval[1][4].

Q: What are the key differentiators of elafibranor in the treatment of PBC?

A: Elafibranor is distinguished by its strong safety, efficacy, and improvement in pruritus[1][4].

Q: What financial milestones is GENFIT anticipating related to elafibranor?

A: GENFIT anticipates a €48.7 million milestone payment from Ipsen in June 2024 and additional royalty revenues[2].

Sources

1. GENFIT: new market research data highlight potential of elafibranor in PBC[1].
2. Corporate presentation - Investor Relations | GENFIT[2].
3. Audited consolidated financial statements - GENFIT[3].
4. PRESS RELEASE: GENFIT: new market research data highlight potential of elafibranor in PBC[4].
5. Genfit S.A. (GNFT): history, ownership, mission, how it works[5].