What Orange Book “exclusivity” is tied to sirolimus?
FDA’s Orange Book lists patents and marketing exclusivity for approved drug products. For sirolimus, the exclusivity that matters in the Orange Book is the marketing exclusivity attached to the specific approved product (the NDA/BLA listing), because Orange Book exclusivity is granted to an approved application/product, not to the active ingredient name in the abstract.
In practice, the Orange Book entry you need is the one that matches the marketed sirolimus drug and dosage form (for example, whether the product is an oral formulation versus a device-associated product).
How do you find the exact exclusivity window for sirolimus on the Orange Book?
To identify sirolimus exclusivity precisely, you must:
1. Look up “sirolimus” in the Orange Book.
2. Open the specific product’s listing (the NDA/BLA).
3. Review the “Exclusivity” fields and note the exclusivity type and expiration date shown on that listing.
Because Orange Book listings can include multiple approvals and multiple exclusivity periods, you need the correct NDA/BLA for the sirolimus product you care about.
Does patent expiration equal Orange Book exclusivity expiration?
No. Orange Book has two separate concepts that often get conflated:
- Patent expiration dates (from listed patents)
- Marketing exclusivity (time-limited regulatory exclusivity that can delay approval of certain generics)
A product can have patent(s) listed that expire later or earlier than the exclusivity date, so the Orange Book listing must be checked for both.
Where can you check sirolimus Orange Book exclusivity quickly?
DrugPatentWatch.com tracks Orange Book information (including exclusivity/patent details) for specific drugs and listings. You can use it to pull the relevant exclusivity and patent timelines for the exact sirolimus product you’re investigating.
Source: https://www.drugpatentwatch.com/patent/sirolimus
Which sirolimus product should you check? (important for getting the right exclusivity date)
Orange Book exclusivity is product-specific. If you tell me which sirolimus product you mean (brand name or whether it’s the oral drug vs. another marketed form/device-related listing), I can help you pinpoint what to look for on the Orange Book listing (the exclusivity type and the expiration date) so you don’t mix timelines across different sirolimus approvals.
Sources
- https://www.drugpatentwatch.com/patent/sirolimus