Drug facts
MoleculeRiociguat (Adempas)
Generics already compete: 1 maker on the market. 5 A-rated products from 1 maker substitute at the counter.
Adempas was first approved by the FDA on 10/08/2013 under NDA 204819; the application holder is Bayer Healthcare Pharmaceuticals Inc.
Holder Bayer Healthcare Pharmaceuticals IncApplication NDA 204819Approved 10/08/2013
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.
2,667days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved10/08/2013
Last patent02/18/2034
20142017202020232026202920322035
- Latest patent
- 02/18/2034Adempas Orange Book
02Competition
- Generics
- 1 generic maker Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
- First generic approved
- 09/01/2022 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 Riociguat profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Bayer Healthcare Pharmaceuticals Inc Orange Book
- Application
- NDA 204819 Orange Book
- First approved
- 10/08/2013 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.