Elafibranor - Generic Drug Details

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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

Generic Entry Date for elafibranor^: ⤷ 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 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

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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	Y			⤷ 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 elafibranor

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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 elafibranor

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	038386	СПОСОБЫ ЛЕЧЕНИЯ ХОЛЕСТАТИЧЕСКИХ ЗАБОЛЕВАНИЙ (METHODS OF TREATMENT OF CHOLESTATIC DISEASES)	⤷ Sign Up
Slovenia	1519908		⤷ Sign Up
Japan	4907083		⤷ Sign Up
Brazil	112018069023	métodos de tratamento de doenças colestáticas	⤷ Sign Up
Poland	372809	Podstawione pochodne 1,3-difenyloprop-2-en-1-onu,sposób otrzymywania i zastosowanie podstawionych pochodnych 1,3-difenyloprop-2-enu-1-onu (SUBSTITUTED 1,3-DIPHENYLPROP-2-EN-1-ONE DERIVATIVES AND PREPARATION AND USES THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for elafibranor

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elafibranor

Recent Clinical Trials for elafibranor

Anatomical Therapeutic Chemical (ATC) Classes for elafibranor

Make Better Decisions: Try a trial or see plans & pricing

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