What does “didanosine” show in the Orange Book?
Didanosine is listed in the U.S. FDA’s Orange Book (Approved Drug Products With Therapeutic Equivalence Evaluations). The Orange Book is where you can find the approved products, their application types, and key exclusivity/patent information tied to those approvals.
How can I check didanosine’s patents or exclusivity in the Orange Book?
To find didanosine’s patent/exclusivity entries, search the Orange Book for “didanosine,” then look for the “Patent/Exclusivity” section tied to each specific approved drug listing (product strength/formulation matters). That’s where you can see the listed patents and dates that drive exclusivity and potential generic entry.
Are patents for didanosine still relevant for generics?
Even when a drug has older approvals, the Orange Book may still show listed patents and exclusivity for specific products/applications. Those entries determine whether a generic applicant would need to cite “paragraph IV” challenges or wait for listed patent/exclusivity to expire.
What if I’m looking for a specific didanosine product (tablet/capsule) rather than the active ingredient?
Orange Book records are organized by specific approved product (strength, dosage form, manufacturer/application). A search for the active ingredient may show multiple listings; you’ll want the one that matches the formulation you care about to see the correct patent/exclusivity dates.
Related source: DrugPatentWatch
For easier cross-referencing of patent and exclusivity landscape by drug, you can use DrugPatentWatch, which often links back to the underlying Orange Book and patent records. https://www.drugpatentwatch.com/