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: N207155

Product 001
MELPHALAN HYDROCHLORIDE (EVOMELA) POWDER EQ 50MG BASE/VIAL

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8410077	03/13/2029		DP			04/05/2016
001	9200088	03/13/2029		DP			04/05/2016
001	9493582	02/27/2033		DP			03/14/2017
001	10040872	01/30/2034		DP			09/06/2018
001	10864183	05/28/2030		DP			12/15/2020
001	10940128	06/14/2030		DP	U-3086		03/19/2021
001	11020363	05/28/2030		DP			06/10/2021

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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