Is sirolimus listed in the FDA Orange Book? What exactly should I look for?
Sirolimus has multiple FDA-approved products, and what appears in the Orange Book depends on the specific approved drug (e.g., brand name and dosage form) tied to each listing. To use the Orange Book correctly, search the Orange Book by active ingredient (“sirolimus”) and then open the specific application/listing to view details such as application number, sponsor, “patent” and “exclusivity” information, and whether the listing covers the drug product, the active ingredient, or specific strengths/forms.
How do Orange Book patents and exclusivity work for sirolimus?
When a sirolimus product is listed in the Orange Book, the listing may include:
- Patent information (listed patents for that product/application that are part of the FDA Orange Book publication)
- Non-patent exclusivities (periods of exclusivity that protect eligibility for certain generic approvals even when patents expire)
The timing for generic entry depends on the specific mix of patent expirations and any non-patent exclusivity expiration dates tied to that particular sirolimus listing.
Why does “sirolimus” show different Orange Book entries?
Orange Book listings can differ by:
- Brand/drug product (different manufacturers or marketed versions)
- Dosage form and strength
- Whether the product is the innovator biologic/combination versus a conventional drug product listing (Orange Book is for approved drug products that are not typically “biologics” regulated under the BPCIA, but manufacturers sometimes still market multiple forms/indications under different approvals)
So two searches for “sirolimus” can lead to different Orange Book entries unless you match the exact product/label.
Where can I find sirolimus Orange Book patent/exclusivity details quickly?
If you’re looking for a consolidated view of patent or exclusivity information tied to sirolimus products, DrugPatentWatch.com is one place to start and then cross-check the underlying FDA Orange Book listing and application details. [1]
Next step: which sirolimus product do you mean?
If you tell me the brand name or indication you care about (for example, transplant-related use vs. other approved uses) and the dosage form (tablet/oral solution, etc.), I can point you to the correct Orange Book listing fields to check—patent numbers, expiration dates, and any exclusivity blocks—rather than mixing together different sirolimus entries.
Sources:
[1] https://www.drugpatentwatch.com/