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Last Updated: December 15, 2024

GEPIRONE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for gepirone hydrochloride and what is the scope of freedom to operate?

Gepirone hydrochloride is the generic ingredient in one branded drug marketed by Fabre Kramer and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Gepirone hydrochloride has three patent family members in three countries.

There is one drug master file entry for gepirone hydrochloride. One supplier is listed for this compound.

Summary for GEPIRONE HYDROCHLORIDE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GEPIRONE HYDROCHLORIDE
Generic Entry Date for GEPIRONE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
TABLET, EXTENDED RELEASE;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 GEPIRONE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Duke UniversityPhase 3
Forest LaboratoriesPhase 3
National Institute on Drug Abuse (NIDA)Phase 2

See all GEPIRONE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GEPIRONE HYDROCHLORIDE

US Patents and Regulatory Information for GEPIRONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164-004 Sep 22, 2023 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164-004 Sep 22, 2023 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164-003 Sep 22, 2023 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GEPIRONE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
European Patent Office 1694332 TRAITEMENT DE TROUBLES SEXUELS (TREATMENT OF SEXUAL DISORDERS) ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2005053697 ⤷  Subscribe
Argentina 048128 UN TRATAMIENTO DE LA DIFUNCION SEXUAL ⤷  Subscribe
>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.