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.

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
N203565	FERRIC CARBOXYMALTOSE	INJECTAFER	SOLUTION	INTRAVENOUS	750MG IRON/15ML (50MG IRON/ML)	10519252		RX	01/17/2020
N203565	FERRIC CARBOXYMALTOSE	INJECTAFER	SOLUTION	INTRAVENOUS	500MG IRON/10ML (50MG IRON/ML)	10519252		RX	02/02/2021
N208798	FLUTICASONE PROPIONATE	ARMONAIR RESPICLICK	POWDER	INHALATION	0.232MG/INH	10918816		DISCN	03/18/2021
N208798	FLUTICASONE PROPIONATE	ARMONAIR RESPICLICK	POWDER	INHALATION	0.055MG/INH	10918816		DISCN	03/18/2021
N208798	FLUTICASONE PROPIONATE	ARMONAIR RESPICLICK	POWDER	INHALATION	0.113MG/INH	10918816		DISCN	03/18/2021
N208798	FLUTICASONE PROPIONATE	ARMONAIR RESPICLICK	POWDER	INHALATION	0.232MG/INH	10918816*PED		DISCN
N208798	FLUTICASONE PROPIONATE	ARMONAIR RESPICLICK	POWDER	INHALATION	0.055MG/INH	10918816*PED		DISCN
N208798	FLUTICASONE PROPIONATE	ARMONAIR RESPICLICK	POWDER	INHALATION	0.113MG/INH	10918816*PED		DISCN
N021903	IBUPROFEN LYSINE	NEOPROFEN	INJECTABLE	INTRAVENOUS	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	6344479	U-794 CLOSURE OF A CLINICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN USUAL MEDICAL MANAGEMENT IS INEFFECTIVE	RX
N021398	BRIMONIDINE TARTRATE; TIMOLOL MALEATE	COMBIGAN	SOLUTION/DROPS	OPHTHALMIC	0.2%;EQ 0.5% BASE	7323463		RX
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	7582621	U-2016 TREATMENT FOR ONYCHOMYCOSIS THAT IS TINEA UNGUIUM	RX	07/21/2014
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	7582621*PED		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	10MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	15MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	20MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	30MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	40MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	60MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	80MG	7674799		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	10MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	15MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	20MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	30MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	40MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	60MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	80MG	7674800		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	10MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	15MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	20MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	30MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	40MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	60MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	80MG	7683072		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	10MG	7776314		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	15MG	7776314		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	20MG	7776314		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	30MG	7776314		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	40MG	7776314		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	60MG	7776314		RX
N022272	OXYCODONE HYDROCHLORIDE	OXYCONTIN	TABLET, EXTENDED RELEASE	ORAL	80MG	7776314		RX
N211150	PITOLISANT HYDROCHLORIDE	WAKIX	TABLET	ORAL	EQ 4.45MG BASE	7910605	U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY	RX	09/11/2019
N211150	PITOLISANT HYDROCHLORIDE	WAKIX	TABLET	ORAL	EQ 4.45MG BASE	7910605	U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY	RX	09/11/2019
N211150	PITOLISANT HYDROCHLORIDE	WAKIX	TABLET	ORAL	EQ 17.8MG BASE	7910605	U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY	RX	09/11/2019
N211150	PITOLISANT HYDROCHLORIDE	WAKIX	TABLET	ORAL	EQ 17.8MG BASE	7910605	U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY	RX	09/11/2019
N021775	ALVIMOPAN	ENTEREG	CAPSULE	ORAL	12MG	8112290	U-1443 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS	RX	03/01/2012
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8168209		RX	04/23/2013
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8168209		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8168209		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8168209		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8168209*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8168209*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8168209*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8168209*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8173708	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX	04/23/2013
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8173708	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8173708	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8173708	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8173708*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8173708*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8173708*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8173708*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8283379	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX	04/23/2013
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8283379	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8283379	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8283379	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8283379*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8283379*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8283379*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8283379*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8329752		RX	04/23/2013
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8329752		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8329752		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8329752		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8329752*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8329752*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8329752*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8329752*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8362085	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX	04/22/2013
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8362085	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8362085	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8362085	U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	7MG	8362085*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	14MG	8362085*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	21MG	8362085*PED		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8362085*PED		RX
N206488	ETEPLIRSEN	EXONDYS 51	SOLUTION	INTRAVENOUS	100MG/2ML (50MG/ML)	8486907	U-1904 (I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING	RX	10/17/2016
N206488	ETEPLIRSEN	EXONDYS 51	SOLUTION	INTRAVENOUS	500MG/10ML (50MG/ML)	8486907	U-1904 (I)TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY; (II)RESTORING/INCREASING FUNCTIONAL DYSTROPHIN PROTEIN; OR (III) INDUCING SKIPPING; EACH OF (I)-(III) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING	RX	10/17/2016
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8598233		RX
N022525	MEMANTINE HYDROCHLORIDE	NAMENDA XR	CAPSULE, EXTENDED RELEASE	ORAL	28MG	8598233*PED		RX
N021775	ALVIMOPAN	ENTEREG	CAPSULE	ORAL	12MG	8645160	U-1485 TREATING A SUBJECT UNDERGOING ABDOMINAL SURGERY BY ADMINISTERING ALVIMOPAN TO ACCELERATE THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS	RX
N202736	IVERMECTIN	SKLICE	LOTION	TOPICAL	0.5%	8791153		OTC	08/27/2014
N202736	IVERMECTIN	SKLICE	LOTION	TOPICAL	0.5%	8927595	U-1782 FOR HEAD LICE INFESTATIONS	OTC	12/17/2015
N213973	RIPRETINIB	QINLOCK	TABLET	ORAL	50MG	8940756	U-2829 TREATMENT OF GASTROINTESTINAL STROMAL TUMORS	RX	06/11/2020
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9549938	U-1951 TREATMENT OF ONYCHOMYCOSIS OF A TOENAIL	RX	02/06/2017
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9549938*PED		RX
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9566289		RX	02/21/2017
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9566289*PED		RX
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9566290	U-1970 TREATMENT OF ONYCHOMYCHOSIS OF A TOENAIL CAUSED BY TRICHOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES	RX	02/21/2017
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9566290*PED		RX
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9572823	U-1970 TREATMENT OF ONYCHOMYCHOSIS OF A TOENAIL CAUSED BY TRICHOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES	RX	03/17/2017
N204427	TAVABOROLE	KERYDIN	SOLUTION	TOPICAL	5%	9572823*PED		RX

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

Last Updated November 26, 2021.