Drug facts
BrandVyndamax (Tafamidis)
No generic tafamidis is approved; the latest Vyndamax patent or exclusivity in the Orange Book runs to 08/31/2035.
Vyndamax was first approved by the FDA on 05/03/2019 under NDA 212161; the application holder is Foldrx Pharmaceuticals LLC A Wholly Owned Sub of Pfizer Inc.
Holder Foldrx Pharmaceuticals LLC A Wholly Owned Sub of Pfizer IncApplication NDA 212161Approved 05/03/2019
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.
3,226days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved05/03/2019
Exclusivity ends05/03/2026
Last patent08/31/2035
202020232026202920322035
- Latest patent
- 08/31/2035Vyndamax Orange Book
- Exclusivity
- 05/03/2026Vyndamax 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 Vyndamax profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Foldrx Pharmaceuticals LLC A Wholly Owned Sub of Pfizer Inc Orange Book
- Application
- NDA 212161 Orange Book
- First approved
- 05/03/2019 Orange Book
- Dosage forms
- capsule
- 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.