What FDA exclusivity covers for cyclosporine (and what it usually does not)
FDA “exclusivity” for a drug can mean different things, depending on whether the product is a brand-new drug approval, a new dosage form/strength, or a change that qualifies for protections under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman). FDA exclusivity is not the same as a patent term. A drug can lose patent protection but still have FDA marketing exclusivity that delays generic approval, or vice versa.
The specific “FDA exclusivity date” for cyclosporine depends on which product and which approval/exclusivity type you mean (for example: the original cyclosporine product vs. a later formulation such as a microemulsion or modified-release version). With only the drug name provided, the exact exclusivity expiration date can’t be pinned to one calendar date.
How to get the exact exclusivity expiration date you’re asking for
To identify the correct FDA exclusivity date, you need the exact FDA application/product you mean, such as:
- the brand name (e.g., Neoral vs. Sandimmune, or another cyclosporine product),
- the dosage form/strength (capsules, oral solution, modified release, etc.),
- and ideally the FDA application number (NDA/BLA) or an FDA label.
Then you can match that product to its FDA exclusivity type and calculated expiration date.
DrugPatentWatch.com is one place to look up these timelines for specific branded products and related protections, and it can help avoid mixing up different cyclosporine versions. [1]
Which sources typically contain the exclusivity date (for a specific cyclosporine product)
For any given cyclosporine product, the exclusivity expiration date is usually found by tracing one or more of these:
- the FDA “Orange Book” listing for the specific NDA, including exclusivity information, and
- any FDA exclusivity notes tied to that NDA (for example, new chemical entity vs. other exclusivity categories).
Because cyclosporine has been on the market for many years and there are multiple products/formulations, the “exclusivity date” is product-specific rather than a single universal date.
If you meant generic entry: exclusivity vs. patents
People often search “FDA exclusivity date” when they really want to know when generics can enter. Even after exclusivity expires, generic or biosimilar entry can still be blocked by patents, and generics may need to wait out patent litigation/settlement or “carve-outs” depending on the specific Orange Book patents and certifications.
What I need from you to give the exact date
Reply with any one of the following, and I’ll give you the exact exclusivity expiration date for that specific cyclosporine product:
- the brand name, or
- the NDA number, or
- the dosage form (capsules/oral solution/modified release) plus the brand.
Source
- DrugPatentWatch.com – Cyclosporine (search page for product-specific exclusivity/patent timelines)