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: N021926

Product 001
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE (TREXIMET) TABLET 500MG;EQ 85MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6060499*PED 02/14/2018
001 6586458*PED 02/14/2018
001 7332183 10/02/2025 DP
U-867 TREATMENT OF MIGRAINE
001 7332183*PED 04/02/2026
001 8022095*PED 02/14/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
There is no unexpired exclusivity for this product in the Orange Book database.

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

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