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Last Updated: April 13, 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
Rubicon BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075521-005 Mar 16, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075521-003 Apr 5, 2002 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075385-003 Mar 1, 2002 DISCN 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BUSPAR buspirone hydrochloride CAPSULE;ORAL 021190-003 Dec 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-002 Sep 29, 1986 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-001 Sep 29, 1986 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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