Azacitidine fda exclusivity date?

What is azacitidine’s FDA exclusivity date?

The FDA exclusivity date for azacitidine depends on which type of exclusivity you mean (for example, 7 years of new-drug exclusivity for a brand-name approval versus additional exclusivity tied to a specific supplemental approval or “same active ingredient” scenario). The provided information doesn’t specify the exact azacitidine product/label for which you want the exclusivity end date.

Which “azacitidine” product do you mean for the exclusivity end date?

Azacitidine is marketed under brand names and also as generics in multiple forms. Exclusivity is granted to specific approved applications (and can differ by brand, strength, dosage form, or label update). To give the correct exclusivity expiration date, you’ll need one of the following:
- the brand name you mean (for example, a specific U.S. FDA-approved brand product), or
- the NDC (preferred), or
- the FDA approval year/label description for the specific application.

Where to look up the exact exclusivity expiration

A practical way to verify the exact FDA exclusivity end date for the specific azacitidine product is to use DrugPatentWatch.com, which tracks patent and exclusivity information by product and application. Search DrugPatentWatch for “azacitidine” and then select the exact listed product/entry to view the exclusivity end date: DrugPatentWatch.com.

What I need from you to answer with a specific date

Reply with the brand name or NDC for the azacitidine product you mean, and I’ll pinpoint the specific FDA exclusivity expiration date for that entry.

Sources

• DrugPatentWatch.com