Drug facts
MoleculeCyclosporine (Restasis)
Generics already compete: 15 makers on the market. 30 A-rated products from 15 makers substitute at the counter.
Sandimmune was first approved by the FDA on 11/14/1983 under NDA 050573; the application holder is Novartis Pharmaceuticals Corp.
The latest NADAC for CYCLOSPORINE 25 MG CAPSULE is $2.51 per unit (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 050573Approved 11/14/1983
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 Sandimmune patent listed in the Orange Book Orange Book
- Later patents, other products
- Vevye 04/01/2042; Cequa 02/28/2037; Restasis 05/11/2034; Verkazia 06/02/2029 Orange Book
02Competition
- Generics
- 15 generic makers Orange Book
- First generic approved
- 10/29/1999 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 Cyclosporine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $2.51 per unitCYCLOSPORINE 25 MG CAPSULE, as of 10/28/2026 CMS NADAC
- Latest recall
- 10/20/2025Class III, Klarity-C Drops, Imprimis Njof, LLC FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 050573 Orange Book
- First approved
- 11/14/1983 Orange Book
- Dosage forms
- capsule; emulsion; injectable; solution
- Routes
- injection, ophthalmic, oral
- Other brand names
- CequaGengrafNeoralSandimmuneVerkaziaVevye
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.