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: N214200

Product 001
TRILACICLIB DIHYDROCHLORIDE (COSELA) POWDER EQ 300MG BASE/VIAL

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8598186	10/25/2031	DS	DP			03/10/2021
001	8598197	10/25/2031	DS	DP			03/10/2021
001	9487530	03/14/2034			U-3079 U-3080		03/10/2021
001	9957276	10/25/2031	DS				03/10/2021
001	10085992	03/14/2034			U-3081		03/10/2021
001	10189849	10/25/2031	DS				03/10/2021
001	10189850	10/25/2031		DP			03/10/2021
001	10927120	10/25/2031		DP			03/10/2021
001	10966984	03/14/2034			U-3079 U-3080		05/06/2021
001	11040042	03/14/2034		DP			07/21/2021
001	11529352	07/23/2039			U-3504		01/12/2023
001	11717523	03/14/2034			U-3678 U-3679		08/30/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE	02/12/2026

 

 

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