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Last Updated: March 28, 2024

Buspirone hydrochloride - Generic Drug Details


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

Buspirone hydrochloride is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Aiping Pharm Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rising, Rubicon, Strides Pharma, Teva, Unichem, and Zydus Pharms, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for buspirone hydrochloride. Thirty-nine suppliers are listed for this compound.

Summary for buspirone hydrochloride
Recent Clinical Trials for buspirone hydrochloride

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

SponsorPhase
Johns Hopkins UniversityPhase 2
University of OxfordPhase 2
Valenta Pharm JSCPhase 3

See all buspirone hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for buspirone hydrochloride

US Patents and Regulatory Information for buspirone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Egis BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075119-003 Jan 23, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075022-003 Feb 28, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078246-003 Feb 27, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202330-003 Aug 25, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008-003 Mar 1, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Egis BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075119-001 Mar 14, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208829-003 May 24, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 buspirone hydrochloride

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