FDA Orange Book · active-ingredient family
Buspirone hydrochloride
Buspirone hydrochloride is approved as 2 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BUSPAR · NDA 021190
2
Brand (NDA)
22
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUSPARRLD×4 | BRISTOL MYERS SQUIBB | NDA 021190 | — | Dec 20, 2000 | |
| BUSPARRLD×4 | BRISTOL MYERS SQUIBB | NDA 018731 | — | Sep 29, 1986 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUSPIRONE HYDROCHLORIDE×7 | EPIC PHARMA LLC | ANDA 208972 | — | May 13, 2026 | |
| BUCAPSOL×4 | EPIC PHARMA LLC | ANDA 218628 | — | Apr 29, 2026 | |
| BUSPIRONE HYDROCHLORIDE×4 | UNICHEM | ANDA 210907 | AB | Nov 14, 2019 | |
| BUSPIRONE HYDROCHLORIDE×5 | INVENTIA HLTHCARE | ANDA 209696 | BX | May 03, 2018 | |
| BUSPIRONE HYDROCHLORIDE×5 | AMNEAL PHARMS CO | ANDA 208829 | — | May 24, 2017 | |
| BUSPIRONE HYDROCHLORIDE×5 | AIPING PHARM INC | ANDA 202087 | AB | Dec 16, 2015 | |
| BUSPIRONE HYDROCHLORIDE×4 | HERITAGE PHARMA | ANDA 204582 | AB | Sep 18, 2015 | |
| BUSPIRONE HYDROCHLORIDE×5 | ACCORD HLTHCARE | ANDA 202557 | AB | Dec 30, 2014 | |
| BUSPIRONE HYDROCHLORIDE×5 | STRIDES PHARMA | ANDA 202330 | AB | Aug 25, 2014 | |
| BUSPIRONE HYDROCHLORIDE×5 | ZYDUS PHARMS | ANDA 078888 | AB | Feb 07, 2014 | |
| BUSPIRONE HYDROCHLORIDE×5 | AUROBINDO PHARMA LTD | ANDA 078246 | AB | Feb 27, 2009 | |
| BUSPIRONE HYDROCHLORIDE | OXFORD PHARMS | ANDA 078302 | AB | Dec 17, 2007 | |
| BUSPIRONE HYDROCHLORIDE×3 | OXFORD PHARMS | ANDA 075388 | AB | May 09, 2002 | |
| BUSPIRONE HYDROCHLORIDE×5 | RUBICON RESEARCH | ANDA 075521 | AB | Apr 05, 2002 | |
| BUSPIRONE HYDROCHLORIDE×5 | RISING | ANDA 075413 | AB | Mar 19, 2002 | |
| BUSPIRONE HYDROCHLORIDE×3 | EGIS | ANDA 075119 | — | Mar 14, 2002 | |
| BUSPIRONE HYDROCHLORIDE×3 | IVAX SUB TEVA PHARMS | ANDA 075385 | — | Mar 01, 2002 | |
| BUSPIRONE HYDROCHLORIDE×5 | MYLAN | ANDA 076008 | AB | Mar 01, 2002 | |
| BUSPIRONE HYDROCHLORIDE×4 | MYLAN | ANDA 075467 | — | Feb 28, 2002 | |
| BUSPIRONE HYDROCHLORIDE×4 | TEVA | ANDA 075022 | AB | Feb 28, 2002 | |
| BUSPIRONE HYDROCHLORIDE×3 | NESHER PHARMS | ANDA 075572 | — | Feb 27, 2002 | |
| BUSPIRONE HYDROCHLORIDE×3 | IMPAX LABS INC | ANDA 074253 | AB | Mar 28, 2001 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Buspirone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
