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Last Updated: November 30, 2020

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Buspirone hydrochloride - Generic Drug Details

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What are the generic 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 nineteen drug master file entries for buspirone hydrochloride. Forty-four suppliers are listed for this compound.

Recent Clinical Trials for buspirone hydrochloride

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SponsorPhase
Spaulding Rehabilitation HospitalPhase 2
Online PsychoTherapy ClinicN/A
Queen's UniversityN/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
Strides Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202330-002 Aug 25, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 204582-002 Sep 18, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Oxford Pharms BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 075388-002 May 9, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208829-003 May 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208829-001 May 24, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Yiling BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202087-004 Dec 16, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 210907-003 Nov 14, 2019 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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