Drug facts
MoleculeSertraline (Zoloft)
Generics already compete: 18 makers on the market. 50 A-rated products from 18 makers substitute at the counter.
Zoloft was first approved by the FDA on 12/30/1991 under NDA 019839; the application holder is Viatris Specialty LLC.
The latest NADAC for SERTRALINE HCL 50 MG TABLET is $0.03 per unit (as of 10/28/2026).
Holder Viatris Specialty LLCApplication NDA 019839Approved 12/30/1991
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 Zoloft patent listed in the Orange Book Orange Book
02Competition
- Generics
- 18 generic makers Orange Book
- First generic approved
- 06/30/2006 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 Sertraline profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitSERTRALINE HCL 50 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 11/05/2025Class II, Sertraline Hydrochloride, Lupin Pharmaceuticals Inc. FDA enforcement
04Product
- Application holder
- Viatris Specialty LLC Orange Book
- Application
- NDA 019839 Orange Book
- First approved
- 12/30/1991 Orange Book
- Dosage forms
- capsule; concentrate; tablet
- Routes
- oral
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.