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	7056927	09/10/2024	DS	DP			06/29/2020
001	7419983	07/06/2029	DS	DP			06/29/2020
001	10881659	03/14/2034			U-2842		02/03/2021
001	11045470	03/14/2034			U-2842		07/27/2021
001	11459305	11/07/2028		DP	U-2842		11/02/2022
001	11542239	07/23/2039	DS	DP			02/06/2023
001	11690845	08/27/2040			U-3655		08/02/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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