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Last Updated: August 11, 2020

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BUSPIRONE HYDROCHLORIDE Drug Profile

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When do Buspirone Hydrochloride patents expire, and what generic alternatives are available?

Buspirone Hydrochloride is a drug marketed by 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 Pharm Ltd, and Zydus Pharms. and is included in twenty-one NDAs.

The generic ingredient in BUSPIRONE HYDROCHLORIDE is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Buspirone Hydrochloride

A generic version of BUSPIRONE HYDROCHLORIDE was approved as buspirone hydrochloride by IMPAX LABS INC on March 28th, 2001.

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Drug patent expirations by year for BUSPIRONE HYDROCHLORIDE
Recent Clinical Trials for BUSPIRONE HYDROCHLORIDE

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

SponsorPhase
VA Office of Research and DevelopmentPhase 4
University of LouisvilleEarly Phase 1
Ecole Polytechnique Fédérale de LausannePhase 1

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
Unichem Labs Ltd BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 210907-003 Nov 14, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075385-003 Mar 1, 2002 DISCN 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 076008-005 Mar 28, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Rubicon BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075521-003 Apr 5, 2002 DISCN 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

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