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: N209115

Product 001
RUCAPARIB CAMSYLATE (RUBRACA) TABLET EQ 200MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7351701	07/23/2024			U-2012 U-2273 U-2830		12/21/2016
001	7531530	07/23/2024			U-2012 U-2273 U-2830		12/21/2016
001	8071579	08/12/2027			U-2012 U-2273 U-2830		12/21/2016
001	8143241	08/12/2027			U-2012 U-2273 U-2830		12/21/2016
001	8754072	02/10/2031	DS	DP			12/21/2016
001	8859562	08/04/2031			U-2012 U-2273 U-2830		12/21/2016
001	9045487	02/10/2031	DS	DP			12/21/2016
001	9861638	02/10/2031			U-2012 U-2273		02/06/2018
001	9987285	08/17/2035		DP			06/28/2018
001	10130636	08/17/2035			U-2012 U-2101 U-2273 U-2830		12/17/2018
001	10278974	02/10/2031		DP			06/04/2019

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-168	04/06/2025

 

 

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