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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: N206321

Product 001
LIRAGLUTIDE RECOMBINANT (SAXENDA) SOLUTION 18MG/3ML (6MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6268343 08/22/2022 DS DP U-1255 01/21/2015
001 6268343*PED 02/22/2023
001 6899699*PED 07/01/2022
001 7762994 05/23/2024 DP 01/23/2019
001 7762994*PED 11/23/2024
001 8114833 08/13/2025 DP 01/21/2015
001 8114833*PED 02/13/2026
001 8579869 06/30/2023 DP 01/23/2019
001 8579869*PED 12/30/2023
001 8672898 01/02/2022 DP 01/21/2015
001 8672898*PED 07/02/2022
001 8684969 10/20/2025 DP 01/21/2015
001 8684969*PED 04/20/2026
001 8846618 06/27/2022 DP 03/17/2015
001 8846618*PED 12/27/2022
001 8920383 07/17/2026 DP 02/05/2015
001 8920383*PED 01/17/2027
001 9108002 01/26/2026 DP 09/18/2015
001 9108002*PED 07/26/2026
001 9132239 02/01/2032 DP 09/18/2015
001 9132239*PED 08/01/2032
001 9457154 09/27/2027 DP 10/26/2016
001 9457154*PED 03/27/2028
001 9486588 01/02/2022 DP 12/07/2016
001 9486588*PED 07/02/2022
001 9616180 01/20/2026 DP 08/23/2018
001 9616180*PED 07/20/2026
001 9687611 02/27/2027 DP 09/06/2017
001 9687611*PED 08/27/2027
001 9775953 07/17/2026 DP 11/13/2017
001 9775953*PED 01/17/2027
001 9861757 01/20/2026 DP 08/23/2018
001 9861757*PED 07/20/2026
001 9968659 01/09/2037 U-2438 11/16/2018
001 9968659*PED 07/09/2037
001 10220155 07/17/2026 DP 04/01/2019
001 10220155*PED 01/17/2027
001 10357616 01/20/2026 DP 08/08/2019
001 10376652 01/20/2026 DP 09/13/2019
001 11097063 07/17/2026 DP 09/22/2021
001 11311679 01/20/2026 DP 05/20/2022
001 11446443 10/20/2025 DP 10/11/2022
001 RE46363 08/03/2026 DP 05/10/2017
001 RE46363*PED 02/03/2027

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NPP 12/04/2023

 

 


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