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• 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: N205552

Product 002
IBRUTINIB (IMBRUVICA) CAPSULE 70MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7514444	12/28/2026	DS	DP			01/19/2018
002	7514444*PED	06/28/2027
002	8008309	11/13/2027	DS	DP			01/19/2018
002	8008309*PED	05/13/2028
002	8476284	12/28/2026			U-1456 U-1650 U-1946		01/19/2018
002	8476284*PED	06/28/2027
002	8497277	12/28/2026			U-1456 U-1491 U-1650 U-1946 U-2241 U-2242 U-3422		01/19/2018
002	8497277*PED	06/28/2027
002	8563563	04/26/2027			U-1491 U-1650 U-1946 U-2219		01/19/2018
002	8563563*PED	10/26/2027
002	8697711	12/28/2026	DS	DP			01/19/2018
002	8697711*PED	06/28/2027
002	8703780	12/28/2026			U-1491		01/19/2018
002	8703780*PED	06/28/2027
002	8735403	12/28/2026	DS	DP			01/19/2018
002	8735403*PED	06/28/2027
002	8754090	06/03/2031			U-1456	Y	01/19/2018
002	8754090*PED	12/03/2031
002	8754091	12/28/2026		DP			01/19/2018
002	8754091*PED	06/28/2027
002	8952015	12/28/2026			U-1456 U-1491 U-1650 U-1946		01/19/2018
002	8952015*PED	06/28/2027
002	8957079	12/28/2026	DS	DP			01/19/2018
002	8957079*PED	06/28/2027
002	8999999	06/03/2031			U-1491 U-1946 U-2228		01/19/2018
002	8999999*PED	12/03/2031
002	9125889	06/03/2031			U-1650		01/19/2018
002	9125889*PED	12/03/2031
002	9181257	12/28/2026	DS				01/19/2018
002	9181257*PED	06/28/2027
002	9296753	10/30/2033	DS				01/19/2018
002	9296753*PED	04/30/2034
002	9540382	08/18/2033			U-1456 U-1491 U-1650 U-1946		01/19/2018
002	9540382*PED	02/18/2034
002	9713617	06/03/2033		DP			01/19/2018
002	9713617*PED	12/03/2033
002	9725455	06/03/2033	DS				01/19/2018
002	9725455*PED	12/03/2033
002	9795604	10/24/2034			U-2969 U-2970 U-3422		01/19/2018
002	9795604*PED	04/24/2035
002	9801881	06/03/2031			U-1491		01/19/2018
002	9801881*PED	12/03/2031
002	9801883	06/03/2031			U-2159		01/19/2018
002	9801883*PED	12/03/2031
002	10004746	06/03/2031			U-1684 U-1946 U-2241 U-2242		07/16/2018
002	10004746*PED	12/03/2031
002	10016435	06/03/2031			U-1650		08/03/2018
002	10016435*PED	12/03/2031
002	10106548	06/03/2033	DS	DP			10/26/2018
002	10106548*PED	12/03/2033
002	10125140	06/03/2033	DS	DP			11/16/2018
002	10125140*PED	12/03/2033
002	10294231	06/03/2033		DP			05/23/2019
002	10294231*PED	12/03/2033
002	10294232	06/03/2033		DP			05/23/2019
002	10294232*PED	12/03/2033
002	10463668	10/24/2034			U-2654		11/20/2019
002	10463668*PED	04/24/2035
002	10478439	06/03/2031			U-1650 U-1684 U-1946 U-2241 U-2242 U-2665 U-3422		12/10/2019
002	10478439*PED	12/03/2031
002	10695350	10/24/2034			U-2846		07/14/2020
002	10695350*PED	04/24/2035
002	10751342	06/03/2031			U-1491 U-1946 U-2943 U-2944		09/10/2020
002	10751342*PED	12/03/2031
002	10961251	06/03/2033		DP			04/16/2021
002	10961251*PED	12/03/2033
002	11672803	06/03/2031			U-1684 U-1946 U-2241 U-2242		07/14/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
002	ODE*	08/02/2024
002	NPP	08/24/2025
002	NPP *PED	02/24/2026
002	ODE-405	08/24/2029
002	ODE-405 *PED	02/24/2030

 

 

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