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: N210884

Product 001
SUMATRIPTAN (TOSYMRA) SPRAY 10MG/SPRAY

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8268791 05/09/2026 DP
02/21/2019
001 8440631 05/09/2026 DP
U-1719 ACUTE TREATMENT OF MIGRAINE
02/21/2019
001 9211282 07/19/2031 DP
U-1719 ACUTE TREATMENT OF MIGRAINE
02/21/2019
001 9283280 05/09/2026 DP
02/21/2019
001 9610280 06/16/2030 DP
U-1719 ACUTE TREATMENT OF MIGRAINE
02/21/2019
001 9974770 06/16/2030 DP
U-1719 ACUTE TREATMENT OF MIGRAINE
02/21/2019
001 10603305 06/16/2030 DP
U-1719 ACUTE TREATMENT OF MIGRAINE
03/31/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration

 

 


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