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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: N209210

Product 001
EXENATIDE SYNTHETIC (BYDUREON BCISE) SUSPENSION, EXTENDED RELEASE 2MG/0.85ML (2MG/0.85ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6515117 10/04/2025 DS DP U-2588 08/21/2019
001 6515117*PED 04/04/2026
001 7456254 06/30/2025 DP U-2588 U-2589 U-2590 U-3188 U-3189 U-3190 11/03/2017
001 7456254*PED 12/30/2025
001 7563871 04/15/2024 DP 11/03/2017
001 7563871*PED 10/15/2024
001 7612176 04/13/2025 DP U-2589 U-2590 U-3188 U-3189 U-3190 11/03/2017
001 7612176*PED 10/13/2025
001 8329648 08/18/2026 U-2588 U-2589 U-2590 U-2593 U-2594 U-2595 U-2596 U-3188 U-3189 U-3190 11/03/2017
001 8329648*PED 02/18/2027
001 8361972 03/21/2028 U-2588 08/21/2019
001 8361972*PED 09/21/2028
001 8431685 04/13/2025 DP U-2588 U-2589 U-2590 U-2597 U-3188 U-3189 U-3190 11/03/2017
001 8431685*PED 10/13/2025
001 8461105 04/13/2025 DP U-2588 U-2589 U-2590 U-2597 U-3188 U-3189 U-3190 11/03/2017
001 8461105*PED 10/13/2025
001 8501698 06/20/2027 U-2588 08/21/2019
001 8501698*PED 12/20/2027
001 8895033 10/04/2030 DP U-2589 U-2590 U-2597 U-2601 U-2602 U-3188 U-3189 U-3190 11/03/2017
001 8895033*PED 04/04/2031
001 8906851 08/18/2026 U-2588 U-2589 U-2590 U-2593 U-2597 U-3188 U-3189 U-3190 11/03/2017
001 8906851*PED 02/18/2027
001 9238076 04/15/2024 DP U-2588 U-2589 U-2590 U-2597 U-2599 U-3188 U-3189 U-3190 11/03/2017
001 9238076*PED 10/15/2024
001 9884092 08/18/2026 U-2588 U-2589 U-2590 U-2593 U-2594 U-2595 U-2596 U-2597 U-3188 U-3189 U-3190 03/06/2018
001 9884092*PED 02/18/2027

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NPP 07/22/2024
001 NPP *PED 01/22/2025

 

 


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