Drug facts
MoleculeBuspirone
Generics already compete: 15 makers on the market. 68 A-rated products from 15 makers substitute at the counter.
Buspar was first approved by the FDA on 09/29/1986 under NDA 018731; the application holder is Bristol Myers Squibb Co Pharmaceutical Research Institute. The Orange Book lists NDA 018731 as discontinued.
The latest NADAC for BUSPIRONE HCL 15 MG TABLET is $0.04 per unit (as of 10/28/2026).
Holder Bristol Myers Squibb Co Pharmaceutical Research InstituteApplication NDA 018731Approved 09/29/1986
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Buspar patent listed in the Orange Book Orange Book
02Competition
- Generics
- 15 generic makers Orange Book
- First generic approved
- 03/28/2001 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Buspirone profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.04 per unitBUSPIRONE HCL 15 MG TABLET, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 04/13/2026Class III, Buspirone Hydrochloride, Unichem Pharmaceuticals USA Inc. FDA enforcement
04Product
- Application holder
- Bristol Myers Squibb Co Pharmaceutical Research Institute Orange Book
- Application
- NDA 018731 Orange Book
- First approved
- 09/29/1986 Orange Book
- Dosage forms
- capsule; tablet
- Routes
- oral
- Other brand names
- Bucapsol
- Status
- NDA 018731 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.