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-three 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: | 43 |
| 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
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | Phase 2 |
| University of Oxford | Phase 2 |
| Valenta Pharm JSC | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rubicon | BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 075521-001 | Apr 5, 2002 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Epic Pharma Llc | BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 208972-003 | Apr 16, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 075467-004 | Feb 28, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Accord Hlthcare | BUSPIRONE HYDROCHLORIDE | buspirone hydrochloride | TABLET;ORAL | 202557-005 | Dec 30, 2014 | 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 | TABLET;ORAL | 018731-003 | Apr 22, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | BUSPAR | buspirone hydrochloride | TABLET;ORAL | 018731-003 | Apr 22, 1996 | ⤷ 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 | CAPSULE;ORAL | 021190-001 | Dec 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
