Drug facts
BrandEmpaveli (Pegcetacoplan)
No generic pegcetacoplan is approved; the latest Empaveli patent or exclusivity in the Orange Book runs to 12/14/2038.
Empaveli was first approved by the FDA on 05/14/2021 under NDA 215014; the application holder is Apellis Pharmaceuticals Inc.
Holder Apellis Pharmaceuticals IncApplication NDA 215014Approved 05/14/2021
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.
4,427days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved05/14/2021
Exclusivity ends07/28/2032
Last patent12/14/2038
2022202520282031203420372040
- Latest patent
- 12/14/2038Empaveli Orange Book
- Exclusivity
- 07/28/2032Empaveli 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 Empaveli profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Apellis Pharmaceuticals Inc Orange Book
- Application
- NDA 215014 Orange Book
- First approved
- 05/14/2021 Orange Book
- Dosage forms
- solution
- Routes
- subcutaneous
- Other brand names
- Syfovre
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.