Drug facts
MoleculeFluoxetine
Generics already compete: 21 makers on the market. 59 A-rated products from 20 makers substitute at the counter.
Prozac was first approved by the FDA on 12/29/1987 under NDA 018936; the application holder is Eli Lilly and Co. The Orange Book lists NDA 018936 as discontinued.
The latest NADAC for FLUOXETINE HCL 20 MG CAPSULE is $0.03 per unit (as of 10/28/2026).
Holder Eli Lilly and CoApplication NDA 018936Approved 12/29/1987
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 Prozac patent listed in the Orange Book Orange Book
02Competition
- Generics
- 21 generic makers Orange Book
- First generic approved
- 08/02/2001 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 Fluoxetine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitFLUOXETINE HCL 20 MG CAPSULE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 05/27/2025Class II, Fluoxetine Tablets, Torrent Pharma Inc. FDA enforcement
04Product
- Application holder
- Eli Lilly and Co Orange Book
- Application
- NDA 018936 Orange Book
- First approved
- 12/29/1987 Orange Book
- Dosage forms
- capsule; capsule, delayed rel pellets; solution; tablet
- Routes
- oral
- Status
- NDA 018936 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.