Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Delisted Patents

The following is a list of patents that have been delisted since the most recent Annual Edition of the Orange Book.

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.

The following is a list of patents that have been delisted since the most recent Annual Edition of the Orange Book.

65 records returned

Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No.	Patent Use	Mkt. Status	Submission Date
Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No.	Patent Use	Mkt. Status	Submission Date
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	60MG	6559188	U-827	DISCN
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	120MG	6559188	U-827	DISCN
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	60MG	6878749		DISCN
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	120MG	6878749		DISCN
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975	U-533	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975	U-614	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975	U-1184	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	6821975	U-533	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	6821975	U-614	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	20MG	6821975	U-533	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	20MG	6821975	U-614	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	2.5MG	6821975	U-533	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	2.5MG	6821975	U-614	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975*PED		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	6821975*PED		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	20MG	6821975*PED		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	2.5MG	6821975*PED		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	7182958	U-155	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	7182958	U-1184	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	7182958	U-155	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	7182958*PED		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	7182958*PED		RX
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7410978		DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7759359	U-1071	DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7763635	U-1071	DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7781448	U-1071	DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7781449	U-1071	DISCN
N022161	REGADENOSON	LEXISCAN	SOLUTION	INTRAVENOUS	0.4MG/5ML (0.08MG/ML)	6642210	U-869	RX
N022161	REGADENOSON	LEXISCAN	SOLUTION	INTRAVENOUS	0.4MG/5ML (0.08MG/ML)	9085601		RX	08/17/2015
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	15MG	9060976		RX	06/23/2015
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	20MG	9060976		RX	06/23/2015
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	30MG	9060976		RX	06/23/2015
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	40MG	9060976		RX	06/23/2015
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	60MG	9060976		RX	06/23/2015
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	80MG	9060976		RX	06/23/2015
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995	U-1306	DISCN	12/11/2012
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995	U-1575	DISCN	12/11/2012
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995*PED		DISCN
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 5MG BASE	8404703	U-1381	RX	04/23/2013
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 10MG BASE	8404703	U-1381	RX	04/23/2013
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 5MG BASE	8404703*PED		RX
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 10MG BASE	8404703*PED		RX
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 5MG BASE	8569325	U-1381	RX	10/31/2013
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 10MG BASE	8569325	U-1381	RX	10/31/2013
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 5MG BASE	8569325*PED		RX
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 10MG BASE	8569325*PED		RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	6821975		RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	6821975*PED		RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	7182958		RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	7182958*PED		RX
N022348	IBUPROFEN	CALDOLOR	SOLUTION	INTRAVENOUS	800MG/8ML (100MG/ML)	9072661	U-2264	RX	04/18/2018
N022348	IBUPROFEN	CALDOLOR	SOLUTION	INTRAVENOUS	800MG/8ML (100MG/ML)	9072710	U-2266	RX	04/19/2018
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	250MG	8822438	U-1579	RX	10/01/2014
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	250MG	8822438	U-1580	RX	10/01/2014
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	250MG	8822438	U-2235	RX	10/01/2014
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	500MG	8822438	U-1579	RX	08/02/2017
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	500MG	8822438	U-1580	RX	08/02/2017
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	500MG	8822438	U-2235	RX	08/02/2017
N204958	CANGRELOR	KENGREAL	POWDER	INTRAVENOUS	50MG/VIAL	8759316	U-1715	RX	07/16/2015
N205636	ALBUTEROL SULFATE	PROAIR RESPICLICK	POWDER, METERED	INHALATION	EQ 0.09MG BASE/INH	9782550		RX	01/09/2019
N205636	ALBUTEROL SULFATE	PROAIR RESPICLICK	POWDER, METERED	INHALATION	EQ 0.09MG BASE/INH	9782551		RX	01/09/2019
N208583	INSULIN DEGLUDEC; LIRAGLUTIDE	XULTOPHY 100/3.6	SOLUTION	SUBCUTANEOUS	300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)	7686786		RX	12/09/2016
N208583	INSULIN DEGLUDEC; LIRAGLUTIDE	XULTOPHY 100/3.6	SOLUTION	SUBCUTANEOUS	300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)	7686786*PED		RX
N208751	INSULIN ASPART	FIASP FLEXTOUCH	SOLUTION	SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	7686786		RX	10/25/2017
N210361	GLYCOPYRRONIUM TOSYLATE	QBREXZA	CLOTH	TOPICAL	EQ 2.4% BASE	9006462		RX	09/20/2018

View a list of all patent use codes
View a list of all exclusivity codes

Last Updated September 19, 2019.