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Last Updated: October 19, 2020

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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 Labs Ltd, Yiling, and Zydus Pharms, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for buspirone hydrochloride. Forty-three suppliers are listed for this compound.

Recent Clinical Trials for buspirone hydrochloride

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SponsorPhase
Spaulding Rehabilitation HospitalPhase 2
Queen's UniversityN/A
Online PsychoTherapy ClinicN/A

See all buspirone hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for buspirone hydrochloride
Paragraph IV (Patent) Challenges for BUSPIRONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BUSPAR TABLET;ORAL buspirone hydrochloride 018731

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
Amneal Pharms Co BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208829-002 May 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075467-001 Feb 28, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078888-004 Feb 7, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 074253-002 Mar 28, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 076008-004 Mar 1, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202330-003 Aug 25, 2014 AB RX No No   Start Trial   Start Trial   Start 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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