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Last Updated: November 2, 2024

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, Aiping Pharm Inc, Amneal Pharms Co, Aurobindo Pharma Ltd, Egis, Epic Pharma Llc, Heritage Pharma, Impax Labs Inc, Inventia Hlthcare, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Oxford Pharms, Rising, Rubicon, Strides Pharma, Teva, Unichem, 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
US Patents:0
Tradenames:2
Applicants:20
NDAs:23
Drug Master File Entries: 16
Finished Product Suppliers / Packagers: 42
Raw Ingredient (Bulk) Api Vendors: 111
Clinical Trials: 75
Patent Applications: 946
What excipients (inactive ingredients) are in buspirone hydrochloride?buspirone hydrochloride excipients list
DailyMed Link:buspirone hydrochloride at DailyMed
Recent Clinical Trials for buspirone hydrochloride

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

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
Anatomical Therapeutic Chemical (ATC) Classes 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
Strides Pharma BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202330-003 Aug 25, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aiping Pharm Inc BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202087-001 Dec 16, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aiping Pharm Inc BUSPIRONE HYDROCHLORIDE buspirone hydrochloride TABLET;ORAL 202087-003 Dec 16, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BUSPAR buspirone hydrochloride CAPSULE;ORAL 021190-004 Dec 20, 2000 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-002 Sep 29, 1986 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BUSPAR buspirone hydrochloride TABLET;ORAL 018731-004 Apr 22, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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