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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: N215256

Product 004
SEMAGLUTIDE (WEGOVY) SOLUTION 1.7MG/0.75ML (1.7MG/0.75ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
004 8129343 12/05/2031 DS DP 06/30/2021
004 8536122 03/20/2026 DS DP 06/30/2021
004 9764003 06/21/2033 U-3161 06/30/2021
004 10888605 08/24/2038 DP U-3162 06/30/2021
004 11318191 02/17/2041 DP U-3162 06/29/2022
004 11752198 08/24/2038 DP U-3162 10/10/2023

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
004 NP 06/04/2024
004 NPP 12/23/2025
004 D-190 07/21/2026
004 I-935 03/08/2027

 

 


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