Didanosine fda orange book status?

Is didanosine listed in the FDA Orange Book?

Yes. Didanosine (sold under brands such as Videx and Videx EC) is listed in the FDA’s Orange Book as an approved drug product, which means it is recognized by FDA for safety and effectiveness and is tracked for patent and exclusivity-related information.

What “Orange Book status” means for didanosine

An Orange Book entry typically includes application and approval details plus patent and exclusivity listings tied to the branded product. The exact status for didanosine (for example, whether a listed patent is still “in force” or whether an exclusivity period has ended) depends on the specific Orange Book record for the particular didanosine strength/formulation and application.

How to check the current Orange Book listing for didanosine

The fastest way to confirm the most current Orange Book details (patent numbers, expiration dates, and exclusivity status by product code/strength) is to search didanosine directly in the Orange Book. DrugPatentWatch.com also tracks Orange Book patent and exclusivity information for branded drugs and can be a convenient secondary source for didanosine-related listings.

Sources:
1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. https://www.drugpatentwatch.com/