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: N206488

Product 001
ETEPLIRSEN (EXONDYS 51) 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	9018368	06/28/2025	DS	DP			10/17/2016
001	9243245	10/27/2028	DS		U-2097 U-2098		08/24/2017
001	9506058	03/14/2034			U-1918 U-1919		12/01/2016
001	10337003	03/14/2034			U-1918		09/10/2019
001	10364431	03/14/2034			U-1918 U-1919		08/28/2019
001	10781451	06/28/2025	DS	DP			10/19/2020
001	RE47751	06/28/2025			U-1918 U-2664 U-2673 U-2674		12/18/2019
001	RE47769	02/02/2029		DP			12/18/2019
001	RE48468	10/27/2028			U-2097		04/12/2021

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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