IQIRVO Drug Patent Profile

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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

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Summary for IQIRVO

International Patents:	80
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	261
What excipients (inactive ingredients) are in IQIRVO?	IQIRVO excipients list
DailyMed Link:	IQIRVO at DailyMed

Drug patent expirations by year for IQIRVO

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

Generic Entry Date for IQIRVO^: ⤷ Sign Up* 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IQIRVO is ⤷ Sign Up.

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.

Patents protecting IQIRVO

Methods of treatment of cholestatic diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN PATIENTS UNABLE TO TOLERATE UDCA

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN PATIENTS UNABLE TO TOLERATE UDCA

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting IQIRVO

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
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for IQIRVO

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024	⤷ Sign Up	⤷ Sign Up
Ipsen	IQIRVO	elafibranor	TABLET;ORAL	218860-001	Jun 10, 2024	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for IQIRVO

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

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Country	Patent Number	Title	Estimated Expiration
China	1668565	Substituted 1, 3-diphenylprop-2-en-1-one derivatives and preparation and uses thereof	⤷ Sign Up
Eurasian Patent Organization	201892202	СПОСОБЫ ЛЕЧЕНИЯ ХОЛЕСТАТИЧЕСКИХ ЗАБОЛЕВАНИЙ	⤷ Sign Up
Germany	60314420		⤷ Sign Up
Japan	4575771		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004005233		⤷ Sign Up
Australia	2003264699	COMPOSITION BASED ON SUBSTITUTED 1,3-DIPHENYLPROP-2-EN-1-ONE DERIVATIVES, PREPARATION AND USES THEREOF	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration