Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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: N211970

Product 001
GOLODIRSEN (VYONDYS 53) SOLUTION 100MG/2ML (50MG/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 9024007 06/28/2025 DS DP
12/18/2019
001 9416361 05/04/2021 DS
12/18/2019
001 9994851 06/28/2025 DS DP
12/18/2019
001 10227590 06/28/2025 DS DP
12/18/2019
001 10266827 06/28/2025
U-2675 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
12/18/2019
001 10421966 06/28/2025 DS DP
12/18/2019
001 10533174 05/04/2021 DP
01/31/2020
001 10968450 06/28/2025 DS DP
06/01/2021
001 10995337 06/28/2025 DP
U-2675 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
06/01/2021
001 RE47691 06/28/2025 DP
12/18/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
12/12/2024
001
ODE-280INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
COMPETITIVE GENERIC THERAPY
12/12/2026

 

 


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