Drug facts
BrandLeqvio (Inclisiran)
No generic inclisiran is approved; the latest Leqvio patent or exclusivity in the Orange Book runs to 08/25/2036.
Leqvio was first approved by the FDA on 12/22/2021 under NDA 214012; the application holder is Novartis Pharmaceuticals Corp.
Holder Novartis Pharmaceuticals CorpApplication NDA 214012Approved 12/22/2021
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.
3,586days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved12/22/2021
Exclusivity ends02/12/2033
Last patent08/25/2036
202220252028203120342037
- Latest patent
- 08/25/2036Leqvio Orange Book
- Exclusivity
- 02/12/2033Leqvio 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 Leqvio profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 214012 Orange Book
- First approved
- 12/22/2021 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.