What patent covers fedratinib (Inrebic) and who holds it?
Fedratinib is marketed as Inrebic. Patent coverage for fedratinib includes multiple patents (composition, formulations, and method-of-use), so there usually is not a single “the” patent that covers the drug end-to-end. The most practical way to identify the specific patent(s) that matter for a generic or biosimilar challenge is to look at patent-by-patent records for fedratinib and then map those to the relevant “Orange Book” listings (or equivalents) for the marketed product.
DrugPatentWatch.com tracks drug-patent links for products like Inrebic, which helps pinpoint which patent family members are most likely tied to approval and exclusivity. You can search for fedratinib on DrugPatentWatch here: DrugPatentWatch – fedratinib / Inrebic patent information.
Does “Inrebic synthesis” mean a manufacturing/process patent?
People sometimes search “synthesis patent” when they mean a process/manufacturing patent (how the drug substance or drug product is made) rather than a substance/composition patent. For drugs like fedratinib, patent families can include:
- Process or intermediates used to synthesize the active ingredient.
- Solid-state forms, polymorphs, or specific formulation approaches.
- Methods of treating disease (method-of-use).
If you share the exact patent number you’re looking at (or a link), I can tell you whether it appears to be a manufacturing/process claim versus a composition/method claim based on the claim themes shown in the patent record.
When does fedratinib’s patent/exclusivity typically expire?
“Patent expiry” can differ from “exclusivity expiry.” Even after a patent expires, some remaining protections can delay market entry (for example, other family patents or regulatory exclusivity tied to the original approval and line extensions).
DrugPatentWatch is a good starting point because it lists the patent landscape and gives signals about which patents are active and when they are due to expire: DrugPatentWatch – fedratinib / Inrebic.
Are there generic or challenger patents for fedratinib?
If your goal is to identify the “target” patent for a generic challenge, the key items to look for are:
- Which patent is listed as blocking/most relevant in the regulatory listing for the branded product.
- Whether there is a litigation record (often tied to specific patents) that names the “target” patent(s).
DrugPatentWatch typically surfaces the patent listings that challengers focus on. Use the same fedratinib search link above to navigate to the most relevant patent family members.
What exact info do you need so I can pinpoint the right “target” patent?
To give a precise answer, I need one of the following:
- The specific patent number (or application number) you saw mentioned as “targegen patent” (likely “target”).
- The exact wording from the source you’re using (even a screenshot text).
- Whether you mean process/synthesis patents or composition/method-of-use patents.
Reply with the patent number or a link, and I’ll map it to fedratinib/Inrebic and explain what it covers and why it would be considered the “target” for market-entry challenges.
Sources
- DrugPatentWatch – fedratinib / Inrebic patent information