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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: N022309

Product 001
TESTOSTERONE (ANDROGEL) GEL, METERED 1.62% (20.25MG/1.25GM ACTUATION)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8466136 10/12/2026 DP 06/24/2013
001 8466137 10/12/2026 U-1103 06/24/2013
001 8466138 10/12/2026 U-1103 06/24/2013
001 8486925 10/12/2026 DP 07/19/2013
001 8729057 10/12/2026 DP
001 8741881 10/12/2026 U-1103 06/25/2014
001 8754070 10/12/2026 DP 07/16/2014
001 8759329 10/12/2026 DP 07/09/2014

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


View a list of all patent use codes
View a list of all exclusivity codes

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