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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: N213312

Product 001

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8911786 02/14/2029 DP U-3259 12/17/2021
001 10206887 04/15/2030 DP 12/17/2021
001 10705070 03/05/2036 DP 12/17/2021
001 10973806 06/29/2036 U-3258 12/17/2021
001 11497737 10/28/2040 DP 11/23/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NP 11/22/2024



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