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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: N210922

Product 001
PATISIRAN SODIUM (ONPATTRO) SOLUTION EQ 10MG BASE/5ML (EQ 2MG BASE/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8058069 04/15/2029 DP 09/06/2018
001 8158601 11/10/2030 DP U-2378 09/06/2018
001 8168775 10/20/2029 DS DP U-2378 09/06/2018
001 8334373 05/27/2025 DS DP 09/06/2018
001 8492359 04/15/2029 DP 09/06/2018
001 8642076 10/03/2027 DP 09/06/2018
001 8741866 10/20/2029 U-2378 09/06/2018
001 8802644 10/21/2030 DP U-2378 09/06/2018
001 8822668 04/15/2029 DP U-2378 09/06/2018
001 9234196 10/20/2029 DP U-2378 09/06/2018
001 9364435 04/15/2029 DP U-2378 09/06/2018
001 9943538 11/04/2023 DP 09/06/2018
001 9943539 11/04/2023 DP 09/06/2018
001 10240152 10/20/2029 DS DP U-2378 09/03/2021
001 11079379 08/27/2035 DS DP U-2378 09/03/2021
001 11141378 04/15/2029 DP 11/09/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 NCE 08/10/2023
001 ODE-197 08/10/2025

 

 


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