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: N213388

Product 001
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM (ORIAHNN (COPACKAGED)) CAPSULE EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 6872728 01/25/2021 DS DP
06/29/2020
001 7056927 09/10/2024 DS DP
06/29/2020
001 7179815 03/07/2021
U-2842 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
06/29/2020
001 7419983 07/06/2024 DS DP
06/29/2020
001 7462625 01/25/2021 DS DP
U-2842 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
06/29/2020
001 10881659 03/14/2034
U-2842 MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
02/03/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
NPNEW PRODUCT
COMPETITIVE GENERIC THERAPY
05/29/2023
001
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
07/23/2023

 

 


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