Drug facts
MoleculeMacitentan (Opsumit)
Generics already compete: 12 makers on the market. 12 A-rated products from 12 makers substitute at the counter.
Opsumit was first approved by the FDA on 10/18/2013 under NDA 204410; the application holder is Actelion Pharmaceuticals US Inc.
Holder Actelion Pharmaceuticals US IncApplication NDA 204410Approved 10/18/2013
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.
1,083days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved10/18/2013
Exclusivity ends08/28/2028
Last patent10/18/2029
201420172020202320262029
- Latest patent
- 10/18/2029Opsumit Orange Book
- Exclusivity
- 08/28/2028Opsumit Orange Book
02Competition
- Generics
- 12 generic makers Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
- First generic approved
- 04/06/2021 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 Macitentan 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 204410 Orange Book
- First approved
- 10/18/2013 Orange Book
- Dosage forms
- 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.