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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: N209637

Product 003
SEMAGLUTIDE (OZEMPIC) SOLUTION 8MG/3ML (2.68MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
003 7762994 05/23/2024 DP 04/29/2022
003 8114833 08/13/2025 DP 04/29/2022
003 8129343 12/05/2031 DS DP U-3355 04/29/2022
003 8536122 03/20/2026 DS DP U-3355 04/29/2022
003 8684969 10/20/2025 DP 04/29/2022
003 8920383 07/17/2026 DP 04/29/2022
003 9108002 01/20/2026 DP 04/29/2022
003 9132239 02/01/2032 DP 04/29/2022
003 9457154 09/29/2027 DP 04/29/2022
003 9616180 01/20/2026 DP 04/29/2022
003 9687611 02/27/2027 DP 04/29/2022
003 9775953 07/17/2026 DP 04/29/2022
003 9861757 01/20/2026 DP 04/29/2022
003 10220155 07/17/2026 DP 04/29/2022
003 10357616 01/20/2026 DP 04/29/2022
003 10376652 01/20/2026 DP 04/29/2022
003 11097063 07/17/2026 DP 04/29/2022
003 11311679 01/20/2026 DP 05/20/2022
003 11446443 10/20/2025 DP 10/07/2022
003 RE46363 08/03/2026 DP 04/29/2022

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
003 D-185 03/28/2025

 

 


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