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Delisted Patents

About This List

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

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.

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

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

Last Updated December 12, 2019.

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