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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: N207071

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7700076 09/18/2027 DP 08/26/2015
001 8435498 03/01/2024 U-1727 08/26/2015
001 8722021 10/24/2023 DP 08/26/2015
001 8900554 10/24/2023 DP 08/26/2015
001 9211259 02/28/2029 U-1796 01/14/2016
001 9265725 12/08/2027 DP 03/23/2016
001 10117812 10/18/2027 DP U-1796 11/15/2018
001 10322085 10/24/2023 DP 06/21/2019

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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