Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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.

75 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
N020181 SOYBEAN OIL LIPOSYN III 30% INJECTABLE INJECTION 30% 9717852 DISCN 07/11/2018
N021272 TREPROSTINIL REMODULIN INJECTABLE IV (INFUSION), SUBCUTANEOUS 1MG/ML 8497393 RX 08/20/2013
N021272 TREPROSTINIL REMODULIN INJECTABLE IV (INFUSION), SUBCUTANEOUS 2.5MG/ML 8497393 RX 08/20/2013
N021272 TREPROSTINIL REMODULIN INJECTABLE IV (INFUSION), SUBCUTANEOUS 5MG/ML 8497393 RX 08/20/2013
N021272 TREPROSTINIL REMODULIN INJECTABLE IV (INFUSION), SUBCUTANEOUS 10MG/ML 8497393 RX 08/20/2013
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366 DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366 DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366 DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366 DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366 DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366*PED DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366*PED DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366*PED DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366*PED DISCN
N021410 METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE AVANDAMET TABLET ORAL 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7358366*PED DISCN
N021588 IMATINIB MESYLATE GLEEVEC TABLET ORAL EQ 100MG BASE 7544799 RX
N021588 IMATINIB MESYLATE GLEEVEC TABLET ORAL EQ 400MG BASE 7544799 RX
N021588 IMATINIB MESYLATE GLEEVEC TABLET ORAL EQ 100MG BASE 7544799*PED RX
N021588 IMATINIB MESYLATE GLEEVEC TABLET ORAL EQ 400MG BASE 7544799*PED RX
N021748 METFORMIN HYDROCHLORIDE GLUMETZA TABLET, EXTENDED RELEASE ORAL 1GM 6488962 RX
N022251 LAMOTRIGINE LAMICTAL ODT TABLET, ORALLY DISINTEGRATING ORAL 50MG 7919115 RX
N022251 LAMOTRIGINE LAMICTAL ODT TABLET, ORALLY DISINTEGRATING ORAL 100MG 7919115 RX
N022251 LAMOTRIGINE LAMICTAL ODT TABLET, ORALLY DISINTEGRATING ORAL 50MG 8840925 U-1596 RX 10/22/2014
N022251 LAMOTRIGINE LAMICTAL ODT TABLET, ORALLY DISINTEGRATING ORAL 100MG 8840925 U-1596 RX 10/22/2014
N022251 LAMOTRIGINE LAMICTAL ODT TABLET, ORALLY DISINTEGRATING ORAL 50MG 9339504 U-1596 RX 06/09/2016
N022251 LAMOTRIGINE LAMICTAL ODT TABLET, ORALLY DISINTEGRATING ORAL 100MG 9339504 U-1596 RX 06/09/2016
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7674799 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7674800 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7683072 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 7776314 RX
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 5MG BASE 9662335 RX 06/29/2017
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 10MG BASE 9662335 RX 06/29/2017
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 15MG BASE 9662335 RX 06/29/2017
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 20MG BASE 9662335 RX 06/29/2017
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 25MG BASE 9662335 RX 06/29/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 6479065 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 6479065 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 6495164 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 6495164 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 6667061 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 6667061 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 6824822 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 6824822 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 6872700 U-654 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 6872700 U-654 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 6956026 U-687 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 6956026 U-687 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 7223440 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 7223440 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 7563871 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 7563871 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 7612176 U-1223 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 7612176 U-1223 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 7741269 U-1224 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 7741269 U-1224 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 8216180 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 8216180 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 8439864 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 8439864 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 8690837 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 8690837 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 8758292 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 8758292 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 8827963 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 8827963 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 8998876 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 8998876 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 5MG 9320853 RX 11/15/2017
N202293 DAPAGLIFLOZIN FARXIGA TABLET ORAL 10MG 9320853 RX 11/15/2017
N203496 TREPROSTINIL DIOLAMINE ORENITRAM TABLET, EXTENDED RELEASE ORAL EQ 0.125MG BASE 8497393 RX 01/09/2014
N203496 TREPROSTINIL DIOLAMINE ORENITRAM TABLET, EXTENDED RELEASE ORAL EQ 5MG BASE 8497393 RX 02/09/2017
N207533 ARIPIPRAZOLE LAUROXIL ARISTADA SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 441MG/1.6ML (275.63MG/ML) 9526726 RX 01/19/2017
N208610 DELAFLOXACIN MEGLUMINE BAXDELA TABLET ORAL EQ 450MG BASE 8497378 RX 07/18/2017
N208611 DELAFLOXACIN MEGLUMINE BAXDELA POWDER INTRAVENOUS EQ 300MG BASE/VIAL 8497378 RX 07/18/2017
N209936 COPANLISIB DIHYDROCHLORIDE ALIQOPA POWDER INTRAVENOUS 60MG/VIAL 8466283 U-2124 RX 10/10/2017

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View a list of all exclusivity codes

Last Updated January 18, 2019.

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