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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N021880

Product 005
LENALIDOMIDE (REVLIMID) CAPSULE 2.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
005 7465800 04/27/2027 DS DP 01/17/2012
005 7855217 11/24/2024 DS DP 01/17/2012
005 8741929 03/08/2028 U-1983 06/17/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
005 ODE-131 02/22/2024
005 ODE-241 05/28/2026
005 ODE-245 05/28/2026

 

 


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