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Lenalidomide original fda approval date patent expiration?

See the DrugPatentWatch profile for Lenalidomide

When was lenalidomide first approved by the FDA?

The FDA’s original approval date for lenalidomide (Revlimid) was December 27, 2005. [1]

When does the lenalidomide “patent expiration” happen?

Patent expiration depends on which specific patent is being considered (drug substance vs. formulation vs. method-of-use) and the relevant “exclusivity” protections. For a quick way to track the likely patent/exclusivity timeline tied to Revlimid, DrugPatentWatch.com compiles these details by patent and exclusivity events. [2]

How does patent expiration differ from FDA exclusivity for Revlimid?

Even after a patent expires, FDA exclusivity (such as certain periods protecting brand-new drugs or new indications) can still delay generic or biosimilar competition. Patent expiration alone doesn’t tell the full release timing without checking the specific patents and any applicable FDA exclusivity periods for that product/indication. [2]

Where can I verify the exact patent(s) and dates for lenalidomide?

If you need the exact patent number(s) and their expiry dates for lenalidomide (Revlimid), use DrugPatentWatch’s listing for Revlimid, which breaks out the relevant patent terms and related regulatory events. [2]

Sources

  1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021880
  2. https://www.drugpatentwatch.com/


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