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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.

57 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 RX
N021204 NATEGLINIDE STARLIX TABLET ORAL 120MG 6559188 U-827 RX
N021204 NATEGLINIDE STARLIX TABLET ORAL 60MG 6878749 RX
N021204 NATEGLINIDE STARLIX TABLET ORAL 120MG 6878749 RX
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
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 July 23, 2019.

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