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: N050819

Product 001
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE (ACANYA) GEL 2.5%;EQ 1.2% BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8288434 08/05/2029 DP
U-124 TREATMENT OF ACNE
10/19/2012
001 8663699 06/03/2029
U-124 TREATMENT OF ACNE
03/06/2014
001 8895070 06/03/2029
U-124 TREATMENT OF ACNE
05/19/2015
001 9078870 06/03/2029 DP
10/13/2015
001 10220049 06/03/2029 DP
U-916 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
03/08/2019
001 10624918 06/03/2029
U-916 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
05/11/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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