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 nine patents protecting this drug.

This drug has fifty-eight patent family members in thirty-two 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:	58
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	969
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 nine 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
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

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

International Patents for IQIRVO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017242819
Brazil	112018069023
Canada	3018132
China	109152756
China	114796237

Supplementary Protection Certificates for IQIRVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3435996	301342	Netherlands		PRODUCT NAME: ELAFIBRANOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1855 20240923
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	PA2025535	Lithuania		PRODUCT NAME: ELAFIBRANORAS; REGISTRATION NO/DATE: EU/1/24/1855 20240919
3435996	LUC50022	Luxembourg		PRODUCT NAME: ELAFIBRANOR ET UN DE SES SELS OU ESTERS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/24/1855 20240923