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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: N210491

Product 001
IVACAFTOR; IVACAFTOR, TEZACAFTOR (SYMDEKO (COPACKAGED)) TABLET 150MG;150MG, 100MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 7495103 05/20/2027 DS DP 03/09/2018
001 7645789 05/01/2027 DS DP 03/09/2018
001 7776905 06/03/2027 DS DP 03/09/2018
001 8324242 08/05/2027 U-2246 03/09/2018
001 8354427 07/06/2026 U-3021 01/14/2021
001 8410274 12/28/2026 DP 03/09/2018
001 8415387 11/12/2027 U-2246 03/09/2018
001 8598181 05/01/2027 U-2246 03/09/2018
001 8623905 05/01/2027 DS DP 03/09/2018
001 8629162 06/24/2025 U-2247 03/09/2018
001 8754224 12/28/2026 DS DP 03/09/2018
001 9012496 07/15/2033 U-2248 03/09/2018
001 9670163 12/28/2026 DP U-2246 03/09/2018
001 9931334 12/28/2026 DP U-2275 U-2575 05/01/2018
001 9974781 04/09/2027 DP U-2318 U-2574 06/20/2018
001 10022352 04/09/2027 DP U-2343 U-2573 08/08/2018
001 10058546 07/15/2033 U-2399 U-2572 U-3022 U-3023 09/21/2018
001 10081621 03/25/2031 DP U-2420 U-2571 U-3024 U-3025 10/25/2018
001 10206877 04/14/2035 DP U-2498 U-2570 U-3026 U-3027 03/20/2019
001 10239867 04/09/2027 DS DP U-2512 U-2569 04/19/2019
001 10646481 08/13/2029 DP 06/08/2020
001 11564916 08/13/2029 U-3527 02/28/2023
001 11578062 03/25/2031 DP U-3545 03/16/2023
001 11639347 04/09/2027 DS DP U-2569 05/22/2023

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 ODE-173 02/12/2025
001 ODE-247 06/21/2026
001 ODE-335 12/21/2027

 

 


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