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: N212194

Product 001
GIVOSIRAN SODIUM (GIVLAARI) SOLUTION EQ 189MG BASE/ML (EQ 189MG BASE/ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 8106022 12/12/2029 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 8546143 01/09/2022 DS
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 8828956 12/04/2028 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 9133461 05/14/2033 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 9150605 08/28/2025 DS DP
12/12/2019
001 9631193 03/15/2033
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 9708610 01/01/2024 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 9708615 03/08/2024 DS
12/12/2019
001 10119143 10/03/2034 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 10125364 03/15/2033 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 10131907 08/24/2028 DS DP
U-2672 TREATMENT OF ACUTE HEPATIC PORPHYRIA
12/12/2019
001 10273477 03/08/2024 DS
12/12/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
11/20/2024
001
ODE-273INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP)
COMPETITIVE GENERIC THERAPY
11/20/2026

 

 


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