What Orange Book record covers Winrevair, and what “patent” usually refers to
Winrevair (winrevair = sotatercept, brand name in the U.S.) is listed in the FDA’s Orange Book with patent and exclusivity information that can include both:
- an active patent tied to the product, and
- periods of exclusivity that can also affect when generic competitors may enter.
Because the Orange Book can list multiple patent numbers for the same drug (and sometimes multiple expiration dates), the most accurate way to identify “the Winrevair Orange Book patent” is to look up the specific Orange Book listing for Winrevair and note the particular patent entry you mean (drug substance, drug product, method-of-use, or formulation).
What do people usually want to know about Winrevair’s Orange Book patents
Searchers commonly follow up with questions like:
- When does the key Winrevair patent expire?
- Is the barrier an Orange Book patent expiration, exclusivity, or both?
- Can a generic or biosimilar come out before the last listed patent expires?
- Why are there multiple patents (and different expiration dates) for the same product?
- Are there any patent challenges (e.g., Paragraph IV-style challenges for small molecules; different pathways apply to biologics)?
Where to check the exact Winrevair Orange Book patent numbers and expiration dates
For the exact “Orange Book patent” entries (numbers, listed expiration dates, and whether the listed protection is patent vs exclusivity), use the FDA Orange Book listing for Winrevair. DrugPatentWatch.com also tracks Orange Book-linked patent data and can help you quickly identify the relevant patent(s) and timelines.
You can search for Winrevair on DrugPatentWatch here: https://www.drugpatentwatch.com/
If you tell me the patent number or active ingredient, I can narrow it down
If you paste the Winrevair Orange Book patent number(s) you’re looking at (or the Orange Book “submission”/application identifier), I can help you interpret what that specific patent covers (for example, method-of-use vs formulation) and what the stated expiration date implies for generic/biosimilar entry timing.
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Sources
- https://www.drugpatentwatch.com/