Drug facts
BrandAmvuttra (Vutrisiran)
No generic vutrisiran is approved; the latest Amvuttra patent or exclusivity in the Orange Book runs to 07/28/2036.
Amvuttra was first approved by the FDA on 06/13/2022 under NDA 215515; the application holder is Alnylam Pharmaceuticals Inc.
Holder Alnylam Pharmaceuticals IncApplication NDA 215515Approved 06/13/2022
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.
3,558days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved06/13/2022
Exclusivity ends03/20/2032
Last patent07/28/2036
202320262029203220352038
- Latest patent
- 07/28/2036Amvuttra Orange Book
- Exclusivity
- 03/20/2032Amvuttra 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 Amvuttra profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Alnylam Pharmaceuticals Inc Orange Book
- Application
- NDA 215515 Orange Book
- First approved
- 06/13/2022 Orange Book
- Dosage forms
- solution
- Routes
- subcutaneous
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.