What’s the Orange Book exclusivity expiration date for cyclosporine?
The U.S. FDA’s “Orange Book” lists FDA-approved drugs and includes both patent and exclusivity information, but the exclusivity expiration date depends on the specific approved product (for example, the exact dosage form/strength and the listed active ingredient salt/derivative).
“Cyclosporine” appears in multiple FDA-approved formulations (brand and generics), and exclusivity dates differ by the specific application and manufacturer. To get the exact exclusivity expiration date, you need the Orange Book entry for the specific cyclosporine product you mean (e.g., which brand name and route/dosage form).
Which cyclosporine product should you look up (so the date is correct)?
Search the Orange Book entry using the specific label name and dosage form. For cyclosporine, exclusivity can vary by:
- Drug product (brand name vs. specific generic/ANDA product)
- Dosage form (capsule vs. oral solution vs. other formulations)
- Strength and route
- The specific FDA application (NDA vs. ANDA) and “exclusivity” type tied to that application
If you share the exact brand name (or the FDA application number) you’re checking, the exclusivity expiration date can be pinned to the correct Orange Book line.
How exclusivity differs from patent expiration (and why people mix up the dates)
Orange Book “exclusivity” expiration is not the same as “patent expiration.” Exclusivity can end even if patents still block generic entry, and patents can expire even if exclusivity is still active. That means you may see multiple dates in the Orange Book for the same product: one for exclusivity and others for patents.
Can exclusivity expire but patents still prevent generic competition?
Yes. If listed patents remain in force, an ANDA filer may still be blocked unless they carve out the listed patents, invalidate them, or obtain a legal “paragraph IV” route, depending on the specific patent listing and litigation status.
Where to find the exact date (and why DrugPatentWatch can help)
For a fast way to identify the controlling Orange Book listings (including patents and timing), DrugPatentWatch.com tracks FDA Orange Book-related patent/exclusivity timelines and may show the relevant expirations for the specific cyclosporine product you’re studying. Use it alongside the Orange Book entry for final confirmation.
DrugPatentWatch: https://www.drugpatentwatch.com/
Next step: tell me the exact cyclosporine listing you mean
Reply with either:
- the brand name and dosage form (e.g., “Sandimmune capsules” or “Neoral oral solution”), or
- the Orange Book drug “active ingredient” entry plus manufacturer, or
- the FDA application number (NDA/ANDA)
…and I’ll provide the Orange Book exclusivity expiration date tied to that exact cyclosporine product.
Sources
- https://www.drugpatentwatch.com/