Drug facts
MoleculeSelexipag (Uptravi)
Generics already compete: 2 makers on the market. 14 A-rated products from 2 makers substitute at the counter.
Uptravi was first approved by the FDA on 12/21/2015 under NDA 207947; the application holder is Actelion Pharmaceuticals US Inc.
Holder Actelion Pharmaceuticals US IncApplication NDA 207947Approved 12/21/2015
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.
3,866days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved12/21/2015
Exclusivity ends11/23/2029
Last patent06/01/2037
201620202024202820322036
- Latest patent
- 06/01/2037Uptravi Orange Book
- Exclusivity
- 11/23/2029Uptravi Orange Book
02Competition
- Generics
- 2 generic makers Orange Book
- Staged generics
- 2 passed FDA review, awaiting market entry FDA
- First generic approved
- 12/21/2022 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 Selexipag profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Actelion Pharmaceuticals US Inc Orange Book
- Application
- NDA 207947 Orange Book
- First approved
- 12/21/2015 Orange Book
- Dosage forms
- powder; tablet
- Routes
- intravenous, 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.