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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: N021753

Product 001
ADAPALENE (DIFFERIN) GEL 0.3%

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7579377 02/23/2025 U-818
001 7737181 08/29/2024 DP
001 7834060 03/12/2023 U-1078 11/19/2010
001 7838558 03/12/2023 DP 11/30/2010
001 7868044 03/12/2023 U-1078 01/12/2011
001 8703820 03/12/2023 U-1078 05/21/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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View a list of all exclusivity codes

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