Drug facts
MoleculeTreprostinil (Remodulin)
Generics already compete: 4 makers on the market. 16 A-rated products from 4 makers substitute at the counter.
Remodulin was first approved by the FDA on 05/21/2002 under NDA 021272; the application holder is United Therapeutics Corp.
The most recent FDA recall on record is a Class I recall dated 03/04/2024.
Holder United Therapeutics CorpApplication NDA 021272Approved 05/21/2002
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.
880days until the latest Remodulin patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved05/21/2002
Last patent03/29/2029
20032007201120152019202320272031
- Latest patent
- 03/29/2029Remodulin Orange Book
- Later patents, other products
- Tyvaso 02/03/2042; Tyvaso DPI 02/03/2042 Orange Book
02Competition
- Generics
- 4 generic makers Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
- First generic approved
- 11/30/2017 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 Treprostinil profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- Latest recall
- 03/04/2024Class I, Treprostinil Injection, Par Sterile Products LLC FDA enforcement
04Product
- Application holder
- United Therapeutics Corp Orange Book
- Application
- NDA 021272 Orange Book
- First approved
- 05/21/2002 Orange Book
- Dosage forms
- injectable; powder; solution
- Routes
- inhalation, intravenous, subcutaneous
- Other brand names
- TyvasoTyvaso DPI
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.