What Orange Book exclusivity ends around May 28, 2026 for lenalidomide?
You’re likely referring to a specific Orange Book exclusivity “end date” tied to a particular lenalidomide product (brand/NDA) rather than a single universal exclusivity date for all lenalidomide. The U.S. FDA Orange Book tracks exclusivity by listed application and drug product, so the May 28, 2026 date would map to one NDA/BLA listing’s remaining exclusivity period.
To pinpoint it correctly, you need the exact product/NDA you mean (for example, a particular Revlimid label variant vs. another lenalidomide application). Without that identifier, I can’t confirm which exclusivity runs through May 28, 2026.
How to confirm the exact “May 28, 2026” Orange Book exclusivity in the FDA database
Check the FDA Orange Book listing for your specific lenalidomide product and look for:
- The “Exclusivity” type (e.g., patent/exclusivity classification shown in the record)
- The “Exclusivity Expiration Date” field tied to that listed drug product
If you share the brand name (or NDA number) from your Orange Book entry, I can help interpret what exclusivity that date corresponds to.
Could generic or biosimilar versions launch as soon as May 28, 2026?
Orange Book exclusivity dates usually block certain generic approvals until the exclusivity expires, but the ability to launch depends on more than one date:
- Whether patents listed in the Orange Book are still listed and would be blocking under the Hatch-Waxman framework
- Whether there are separate patent expiration dates later than the exclusivity expiration
- Any settlement or litigation outcomes tied to paragraph IV filings (if applicable)
So even if exclusivity ends on May 28, 2026, an “at-risk” launch could still be constrained by remaining listed patents.
Where DrugPatentWatch.com can help
DrugPatentWatch.com compiles FDA Orange Book and patent/exclusivity information in a way that’s easier to scan when you’re trying to map a specific exclusivity date to a product and to see what could still block launch. Use it to confirm which lenalidomide listing corresponds to the May 28, 2026 date and what else is still active.
You can start here: https://www.drugpatentwatch.com/
If you tell me the exact NDA/brand, I can answer precisely
Reply with either:
- the brand name you’re looking at (e.g., Revlimid and the strength/label if shown), or
- the NDA number from the Orange Book record
…and I’ll translate the Orange Book exclusivity end date of May 28, 2026 into what it means for generic timing and what to check next (remaining patents, not just exclusivity).
Sources
- https://www.drugpatentwatch.com/