IQIRVO Drug Patent Profile

Which patents cover Iqirvo, and what generic alternatives are available?

Iqirvo is a drug marketed by Ipsen and is included in one NDA. There are six patents protecting this drug.

This drug has eighty patent family members in twenty-five countries.

The generic ingredient in IQIRVO is elafibranor. One supplier is listed for this compound. Additional details are available on the elafibranor profile page.

DrugPatentWatch^® Generic Entry Outlook for Iqirvo

Iqirvo will be eligible for patent challenges on June 10, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 10, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for IQIRVO

International Patents:	80
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	271
What excipients (inactive ingredients) are in IQIRVO?	IQIRVO excipients list
DailyMed Link:	IQIRVO at DailyMed

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

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

NDA:

218860

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 IQIRVO

IQIRVO is protected by six US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	11,850,223

Expired US Patents for IQIRVO

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 IQIRVO

See the table below for patents covering IQIRVO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2003264698	SUBSTITUTED 1,3-DIPHENYLPROP-2-EN-1-ONE DERIVATIVES AND PREPARATION AND USES THEREOF
China	1688532	Composition based on substituted 1, 3-diphenylprop-2-en-1-one derivatives, preparation and uses thereof
Eurasian Patent Organization	038386	СПОСОБЫ ЛЕЧЕНИЯ ХОЛЕСТАТИЧЕСКИХ ЗАБОЛЕВАНИЙ (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)
Israel	165696	SUBSTITUTED 1,3-DIPHENYLPROP-2-EN-1-ONE DERIVATIVES AND PREPARATION PROCESS AND USES THEREOF IN THE PREPARATION OF A PHARMACEUTICAL COMPOSITION
South Korea	100947907

IQIRVO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: IQIRVO

Introduction to IQIRVO

IQIRVO, also known as elafibranor, is a groundbreaking drug developed by GENFIT for the treatment of Primary Biliary Cholangitis (PBC), a chronic liver disease. The drug has recently gained significant traction following its approvals in the U.S. and anticipated approval in Europe.

Regulatory Approvals and Milestones

• U.S. FDA Approval: IQIRVO received Accelerated Approval from the U.S. FDA on June 10, 2024, marking a significant milestone for both GENFIT and Ipsen, the company with exclusive global rights to the drug except for China, Hong Kong, Taiwan, and Macau[4].
• European Approval: The European Medicines Agency Committee granted a positive opinion in July 2024, with a final decision on marketing authorization anticipated in the second half of 2024. This approval is expected to clear the path for an additional €26.5 million milestone payment upon pricing and reimbursement approval in three European countries[2][3].

Market Share and Competition

• Projected Market Share: According to Citi's analysis, IQIRVO is expected to capture a 45% market share at its peak, indicating strong market potential. The analysis also suggests that IQIRVO and Gilead's seladelpar can coexist and grow the market for PBC treatments[1].
• Competitive Landscape: Despite competition from Gilead's seladelpar, Citi believes that concerns about competition are exaggerated. The market is expected to expand with both drugs contributing to its growth[1].

Financial Performance and Projections

• Revenue and Milestones: GENFIT reported a significant increase in revenue for the first half of 2024, primarily due to a €48.7 million milestone payment invoiced to Ipsen upon the first commercial sale of IQIRVO in the U.S. This payment was received in August 2024[2][3].
• Cash and Cash Equivalents: As of September 30, 2024, GENFIT's cash and cash equivalents totaled €96.0 million, up from €61.6 million as of June 30, 2024. This increase is largely attributed to the milestone payment and other revenue streams[5].

Operating Expenses and Net Profit

• Operating Expenses: GENFIT's operating expenses decreased in the first half of 2024, mainly due to reduced research and development expenses following the FDA approval of IQIRVO. Contracting costs and other expenses also decreased, reflecting the completion of certain activities[2][3].
• Net Profit: The company reported a net profit of €30.3 million for the first half of 2024, a significant improvement from the net loss of €20.9 million in the same period of 2023[2][3].

Revenue Streams

• Licensing Agreement: GENFIT and Ipsen entered into an exclusive licensing agreement in December 2021. The revenue for the first nine months of 2024 included €48.7 million from the milestone payment, €0.9 million from royalty revenue, and €9.3 million from the partial recognition of deferred income under this agreement[5].
• Transition Services Agreement: Additional revenue was generated from services rendered under the Transition Services Agreement and Part B Transition Services Agreement signed between GENFIT and Ipsen[5].

Peak Sales Projections

• Citi's Forecasts: Citi projects peak sales of IQIRVO to reach €540 million, substantially higher than the consensus estimate of €300 million. This forecast indicates a strong financial trajectory for the drug[1].

Valuation Range

• Scenario Analysis: Citi's scenario analysis suggests a valuation range for Ipsen of €150 to €101, depending on market conditions and performance outcomes. This range reflects the potential impact of IQIRVO's success on Ipsen's overall valuation[1].

CEO's Perspective

• Pascal Prigent, CEO of GENFIT: "The approval of IQIRVO in the United States was a very significant milestone for the entire GENFIT team. We believe IQIRVO can potentially address a significant unmet need for people living with PBC."[2][3]

Future Outlook

• European Commercial Launch: The anticipated final decision on marketing authorization in Europe by the end of 2024 is expected to further boost IQIRVO's market presence and revenue.
• Cash Position: GENFIT's current cash and cash equivalents are expected to fund operating expenses and capital expenditure requirements until at least the start of the fourth quarter of 2025[5].

Key Statistics

• Clinical Efficacy: Recent data presented at the European Association for the Study of the Liver (EASL) indicated that IQIRVO showed sustained efficacy at 78 weeks, with 70% of patients achieving the composite endpoint[1].
• Revenue Growth: Total revenues and other income for GENFIT amounted to €61,199 for the first half of 2024, compared to €15,374 for the same period in 2023[2][3].

Conclusion

The approval and commercial launch of IQIRVO have significantly impacted the market dynamics for PBC treatments. With strong financial projections, a substantial market share, and ongoing regulatory approvals, IQIRVO is poised to dominate the PBC treatment market.

Key Takeaways

• Regulatory Approvals: IQIRVO has received U.S. FDA approval and is awaiting final European approval.
• Market Share: Projected to capture 45% of the PBC treatment market.
• Financial Performance: Significant revenue increase due to milestone payments and royalty income.
• Operating Expenses: Decreased operating expenses following FDA approval.
• Peak Sales Projections: Forecasted peak sales of €540 million.
• Valuation Range: Valuation range for Ipsen between €150 to €101 based on performance outcomes.

Frequently Asked Questions (FAQs)

Q: What is IQIRVO used for? A: IQIRVO (elafibranor) is used for the treatment of Primary Biliary Cholangitis (PBC), a chronic liver disease.

Q: Who developed IQIRVO? A: IQIRVO was developed by GENFIT from its initial discovery through late-stage trials.

Q: What are the key regulatory milestones for IQIRVO? A: IQIRVO received U.S. FDA approval in June 2024 and is awaiting final marketing authorization in Europe, anticipated by the end of 2024.

Q: How much revenue did GENFIT generate from IQIRVO in the first half of 2024? A: GENFIT generated €59.0 million in revenues, including a €48.7 million milestone payment upon the first commercial sale of IQIRVO in the U.S.

Q: What is the projected peak market share for IQIRVO? A: According to Citi's analysis, IQIRVO is expected to capture a 45% market share at its peak.

Cited Sources

1. Investing.com: "Citi maintains 'Buy' on Ipsen stock amid Iqirvo prospects"
2. GENFIT: "GENFIT Reports First Half-Year 2024 Financial Results and Provides Corporate Update"
3. GlobeNewswire: "GENFIT Reports First Half-Year 2024 Financial Results and Provides Corporate Update"
4. PR Newswire: "Ipsen's IQIRVO Approval Has Intensified the Primary Biliary Cholangitis Market Space"
5. BioSpace: "GENFIT Reports Third Quarter 2024 Financial Information"