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Last Updated: January 27, 2023

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, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Fosun Pharma, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rubicon, Strides Pharma, Teva, Unichem, Yiling, 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. Forty-two suppliers are listed for this compound.

Summary for buspirone hydrochloride
Recent Clinical Trials for buspirone hydrochloride

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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
Epic Pharma Llc BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208972-001 Apr 16, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008-001 Jun 28, 2001 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ivax Sub Teva Pharms BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075385-003 Mar 1, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fosun Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075413-002 Mar 19, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075467-004 Feb 28, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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