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Last Updated: October 26, 2021

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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, 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-six 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
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
Epic Pharma Llc BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 208972-005 Apr 16, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Unichem BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 210907-004 Nov 14, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078888-002 Feb 7, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aurobindo Pharma Ltd BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 078246-005 Feb 21, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Strides Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202330-003 Aug 25, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Colorcon
Medtronic
Harvard Business School
Boehringer Ingelheim

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