Drug facts
BrandTagrisso (Osimertinib)
No generic osimertinib is approved; the latest Tagrisso patent or exclusivity in the Orange Book runs to 11/26/2042. 1 staged generic application passed FDA review and waits on patents or exclusivity.
Tagrisso was first approved by the FDA on 11/13/2015 under NDA 208065; the application holder is Astrazeneca Pharmaceuticals LP.
Holder Astrazeneca Pharmaceuticals LPApplication NDA 208065Approved 11/13/2015
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.
5,870days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved11/13/2015
Exclusivity ends12/18/2027
Last patent11/26/2042
20162020202420282032203620402044
- Latest patent
- 11/26/2042Tagrisso Orange Book
- Exclusivity
- 12/18/2027Tagrisso Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 1 passed FDA review, awaiting market entry FDA
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 Tagrisso profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Astrazeneca Pharmaceuticals LP Orange Book
- Application
- NDA 208065 Orange Book
- First approved
- 11/13/2015 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.