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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: N208623

Product 001
MIGALASTAT HYDROCHLORIDE (GALAFOLD) CAPSULE EQ 123MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8592362 02/12/2029 U-2371 Y 09/05/2018
001 9000011 05/16/2027 U-2371 09/05/2018
001 9095584 02/12/2029 U-2371 09/05/2018
001 9480682 05/16/2027 U-2371 09/05/2018
001 9987263 05/16/2027 U-2371 09/05/2018
001 9999618 04/28/2028 U-2372 U-2373 09/05/2018
001 10076514 03/15/2037 U-2371 10/18/2018
001 10251873 05/30/2038 U-2371 05/07/2019
001 10383864 05/16/2027 U-2371 09/04/2019
001 10406143 05/16/2027 U-2371 09/26/2019
001 10471053 05/30/2038 U-2371 12/06/2019
001 10525045 04/28/2028 U-2371 01/17/2020
001 10792278 05/30/2038 U-2371 10/15/2020
001 10792279 05/30/2038 U-2371 10/15/2020
001 10799491 05/30/2038 U-2371 11/05/2020
001 10806727 05/30/2038 U-2371 11/05/2020
001 10813921 02/12/2029 U-2371 11/18/2020
001 10849889 05/30/2038 U-2371 12/17/2020
001 10849890 05/30/2038 U-2371 12/17/2020
001 10857141 05/30/2038 U-2371 12/17/2020
001 10857142 05/30/2038 U-2371 12/17/2020
001 10874655 05/30/2038 U-2371 01/07/2021
001 10874656 05/30/2038 U-2371 01/07/2021
001 10874657 05/30/2038 U-2371 01/07/2021
001 10925866 04/28/2028 U-2371 03/18/2021
001 11033538 04/28/2028 U-2371 07/12/2021
001 11234972 03/15/2037 U-2371 02/25/2022
001 11241422 05/16/2027 U-2371 02/25/2022
001 11278536 05/30/2038 U-2371 04/07/2022
001 11278537 05/30/2038 U-2371 04/07/2022
001 11278538 05/30/2038 U-2371 04/07/2022
001 11278539 05/30/2038 U-2371 04/07/2022
001 11278540 05/30/2038 U-2371 04/07/2022
001 11304940 05/30/2038 DS 04/19/2022
001 11357761 05/30/2038 U-2371 06/28/2022
001 11357762 05/30/2038 U-2371 06/28/2022
001 11357763 05/30/2038 U-2371 06/28/2022
001 11357764 05/30/2038 DS 06/28/2022
001 11357765 05/30/2038 DS 06/28/2022
001 11357784 02/06/2039 U-2371 06/28/2022
001 11376244 05/30/2038 DS 07/25/2022
001 11389436 05/30/2038 U-2371 07/25/2022
001 11389437 05/30/2038 U-2371 07/25/2022
001 11426396 05/30/2038 DS 09/02/2022
001 11458128 05/30/2038 U-2371 10/13/2022
001 11612593 05/30/2038 DS 04/17/2023
001 11612594 05/30/2038 DS 04/17/2023
001 11622962 03/17/2039 DS 04/17/2023
001 11633387 05/30/2038 DS 05/12/2023
001 11633388 03/25/2039 U-2371 05/12/2023
001 11642334 02/20/2039 U-2371 05/12/2023
001 11666564 05/30/2038 U-2371 06/09/2023
001 11786516 05/30/2038 DS 10/25/2023
001 11813255 05/30/2038 U-2371 12/08/2023
001 11826360 02/16/2039 DS 12/08/2023
001 11833164 01/11/2042 U-2371 12/08/2023
001 11903938 08/17/2038 DS U-2371 03/04/2024
001 RE48608 02/12/2029 U-2371 07/22/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001 ODE-205 08/10/2025

 

 


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