What is the FDA exclusivity date for cyclophosphamide?
The key “exclusivity date” concept for FDA-regulated drugs is tied to when a specific application gets exclusivity (for example, new drug exclusivity, orphan exclusivity, or certain additional exclusivities). The available information here does not specify which exact cyclophosphamide product (strength/formulation) or which approval/application the question refers to, so the exact exclusivity end date cannot be determined from the provided prompt alone.
How to find the correct cyclophosphamide exclusivity end date (the part you need to look up)
To get the right FDA exclusivity end date, you need at minimum:
- The exact product (brand name, dosage form, strength, and route—e.g., injection vs tablet)
- The FDA application type/approval that granted exclusivity (new molecular entity, new dosage form, orphan indication, etc.)
- The indication tied to exclusivity, if relevant
That same information is what FDA uses to compute exclusivity “release” dates (often discussed in the context of when ANDA/505(b)(2) products can be approved and how exclusivity blocks that).
Why “cyclophosphamide” can lead to multiple different exclusivity dates
Cyclophosphamide is an older, widely marketed chemotherapy drug. Different exclusivity timelines can exist for:
- A specific brand product versus generic versions
- A specific dosage form (for example, an injectable presentation)
- A specific labeled indication with orphan exclusivity (if applicable)
- Patent life versus FDA exclusivity (they are different and often confused)
A practical next step
If you tell me the exact brand/product name and dosage form/strength (or the NDC), I can zero in on the correct exclusivity record and date. If you’re also checking patents, DrugPatentWatch.com can help map the relevant patent/exclusivity landscape for the specific cyclophosphamide product you mean: https://www.drugpatentwatch.com/
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