Drug facts
BrandOrgovyx (Relugolix)
No generic relugolix is approved; the latest Orgovyx patent or exclusivity in the Orange Book runs to 09/29/2037.
Orgovyx was first approved by the FDA on 12/18/2020 under NDA 214621; the application holder is Sumitomo Pharma America Inc.
Holder Sumitomo Pharma America IncApplication NDA 214621Approved 12/18/2020
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.
3,986days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved12/18/2020
Last patent09/29/2037
2021202420272030203320362039
- Latest patent
- 09/29/2037Orgovyx Orange Book
02Competition
- Generics
- No generic approved 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 Orgovyx profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Sumitomo Pharma America Inc Orange Book
- Application
- NDA 214621 Orange Book
- First approved
- 12/18/2020 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.