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
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	10MG	10097388	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	11/05/2018
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	5MG	10097388	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	11/05/2018
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	30MG	10097388	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	11/05/2018
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	15MG	10097388	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	11/05/2018
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	2MG	10097388	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	11/05/2018
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	20MG	10097388	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	11/05/2018
N021361	RIFAXIMIN	XIFAXAN	TABLET	ORAL	200MG	10314828	U-1481 REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE	RX	07/01/2019
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	60MG	6559188	U-827 USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES	DISCN
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	120MG	6559188	U-827 USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES	DISCN
N022161	REGADENOSON	LEXISCAN	SOLUTION	INTRAVENOUS	0.4MG/5ML (0.08MG/ML)	6642210	U-869 METHOD FOR STIMULATING CORONARY VASODILATION FOR PURPOSES OF IMAGING THE HEART	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975	U-533 ERECTILE DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975	U-1184 TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	6821975	U-614 TREATMENT OF SEXUAL DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	6821975	U-533 ERECTILE DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	6821975	U-614 TREATMENT OF SEXUAL DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	20MG	6821975	U-533 ERECTILE DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	20MG	6821975	U-614 TREATMENT OF SEXUAL DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	2.5MG	6821975	U-533 ERECTILE DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	2.5MG	6821975	U-614 TREATMENT OF SEXUAL DYSFUNCTION	RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	6821975		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
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	6821975*PED		RX
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	60MG	6878749		DISCN
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	120MG	6878749		DISCN
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	7182958	U-155 TREATMENT OF ERECTILE DYSFUNCTION	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	7182958	U-1184 TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA	RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	7182958	U-155 TREATMENT OF ERECTILE DYSFUNCTION	RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	7182958		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	5MG	7182958*PED		RX
N021368	TADALAFIL	CIALIS	TABLET	ORAL	10MG	7182958*PED		RX
N022332	TADALAFIL	ADCIRCA	TABLET	ORAL	20MG	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
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
N208751	INSULIN ASPART	FIASP FLEXTOUCH	SOLUTION	SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	7686786		RX	10/25/2017
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
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 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION	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 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION	DISCN
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	7765106	U-1069 A METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING AN EXCLUSIVE COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION	RX
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	7765106*PED		RX
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	7765107	U-1070 A METHOD TO CONTROL ABUSE OF A SENSITIVE DRUG BY CONTROLLING WITH A COMPUTER PROCESSOR THE DISTRIBUTION OF THE SENSITIVE DRUG VIA AN EXCLUSIVITY CENTRAL PHARMACY THAT MAINTAINS A CENTRAL DATABASE	RX
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	7765107*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	7781448	U-1071 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION	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 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION	DISCN
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	7895059	U-1110 METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION	RX
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	7895059*PED		RX
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995	U-1575 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY	DISCN	12/11/2012
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995	U-1306 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY	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 USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS	RX	04/23/2013
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 10MG BASE	8404703	U-1381 USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS	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
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	8457988	U-1110 METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION	RX	07/02/2013
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	8457988*PED		RX
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 5MG BASE	8569325	U-1381 USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS	RX	10/31/2013
N022307	PRASUGREL HYDROCHLORIDE	EFFIENT	TABLET	ORAL	EQ 10MG BASE	8569325	U-1381 USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS	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
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	8589182	U-1110 METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION	RX
N021196	SODIUM OXYBATE	XYREM	SOLUTION	ORAL	500MG/ML	8589182*PED		RX
N022250	DALFAMPRIDINE	AMPYRA	TABLET, EXTENDED RELEASE	ORAL	10MG	8663685	U-1030 IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)	RX	04/02/2014
N204958	CANGRELOR	KENGREAL	POWDER	INTRAVENOUS	50MG/VIAL	8759316	U-1715 P2Y12 PLATELET INHIBITOR FOR USE AS ADJUNCT TO PERCUTANEOUS CORONARY INTERVENTION TO REDUCE RISK OF VARIOUS DISEASES/CONDITIONS IN PATIENTS NOT TREATED WITH A P2Y12 PLATELET INHIBITOR AND NOT GIVEN A GLYCOPROTEIN IIB/IIIA INHIBITOR	RX	07/16/2015
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	250MG	8822438	U-1579 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER	RX	10/01/2014
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	250MG	8822438	U-1580 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAD RECEIVED PRIOR DOCETAXEL CHEMOTHERAPY	RX	10/01/2014
N202379	ABIRATERONE ACETATE	ZYTIGA	TABLET	ORAL	250MG	8822438	U-2235 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER	RX	10/01/2014
N210361	GLYCOPYRRONIUM TOSYLATE	QBREXZA	CLOTH	TOPICAL	EQ 2.4% BASE	9006462		RX	09/20/2018
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
N022348	IBUPROFEN	CALDOLOR	SOLUTION	INTRAVENOUS	800MG/8ML (100MG/ML)	9072661	U-2264 METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION	RX	04/18/2018
N022348	IBUPROFEN	CALDOLOR	SOLUTION	INTRAVENOUS	800MG/8ML (100MG/ML)	9072710	U-2266 METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION	RX	04/19/2018
N022161	REGADENOSON	LEXISCAN	SOLUTION	INTRAVENOUS	0.4MG/5ML (0.08MG/ML)	9085601		RX	08/17/2015
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	10MG	9270503	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	5MG	9270503	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	30MG	9270503	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	15MG	9270503	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	2MG	9270503	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	20MG	9270503	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
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
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	10MG	9787511	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	5MG	9787511	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	30MG	9787511	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	15MG	9787511	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	2MG	9787511	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N207202	ARIPIPRAZOLE	ABILIFY MYCITE KIT	TABLET	ORAL	20MG	9787511	U-2169 METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT	RX	12/12/2017
N022250	DALFAMPRIDINE	AMPYRA	TABLET, EXTENDED RELEASE	ORAL	10MG	9918973	U-1030 IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)	RX	04/17/2018

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Last Updated December 12, 2019.