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.

96 records returned
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Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No. Patent Use Code Mkt. Status
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No. Patent Use Code Mkt. Status
N012827 GLYCOPYRROLATE ROBINUL TABLET ORAL 1MG 7091236 U-877 RX
N012827 GLYCOPYRROLATE ROBINUL FORTE TABLET ORAL 2MG 7091236 U-877 RX
N020533 ROPIVACAINE HYDROCHLORIDE NAROPIN SOLUTION INJECTION 20MG/10ML (2MG/ML) 7828787 RX
N020533 ROPIVACAINE HYDROCHLORIDE NAROPIN SOLUTION INJECTION 20MG/10ML (2MG/ML) 7857802 RX
N020533 ROPIVACAINE HYDROCHLORIDE NAROPIN SOLUTION INJECTION 20MG/10ML (2MG/ML) 8118802 RX
N020533 ROPIVACAINE HYDROCHLORIDE NAROPIN SOLUTION INJECTION 20MG/10ML (2MG/ML) 8162915 RX
N020720 TROGLITAZONE REZULIN TABLET ORAL 200MG 5859037 U-251 DISCN
N020720 TROGLITAZONE REZULIN TABLET ORAL 400MG 5859037 U-251 DISCN
N020720 TROGLITAZONE REZULIN TABLET ORAL 300MG 5859037 U-251 DISCN
N020720 TROGLITAZONE REZULIN TABLET ORAL 200MG 6011049 U-301 DISCN
N020720 TROGLITAZONE REZULIN TABLET ORAL 400MG 6011049 U-301 DISCN
N020720 TROGLITAZONE REZULIN TABLET ORAL 300MG 6011049 U-301 DISCN
N020759 TROVAFLOXACIN MESYLATE TROVAN TABLET ORAL EQ 100MG BASE 6187341 DISCN
N020759 TROVAFLOXACIN MESYLATE TROVAN TABLET ORAL EQ 200MG BASE 6187341 DISCN
N020760 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE INJECTABLE INJECTION EQ 200MG BASE/VIAL 6080756 DISCN
N020760 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE INJECTABLE INJECTION EQ 300MG BASE/VIAL 6080756 DISCN
N020760 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE INJECTABLE INJECTION EQ 200MG BASE/VIAL 6194429 DISCN
N020760 ALATROFLOXACIN MESYLATE TROVAN PRESERVATIVE FREE INJECTABLE INJECTION EQ 300MG BASE/VIAL 6194429 DISCN
N020862 DOXERCALCIFEROL HECTOROL CAPSULE ORAL 2.5MCG 6903083 RX
N020862 DOXERCALCIFEROL HECTOROL CAPSULE ORAL 0.5MCG 6903083 RX
N021107 ALOSETRON HYDROCHLORIDE LOTRONEX TABLET ORAL EQ 1MG BASE 6284770 U-405 RX
N021107 ALOSETRON HYDROCHLORIDE LOTRONEX TABLET ORAL EQ 0.5MG BASE 6284770 U-405 RX
N021372 PALONOSETRON HYDROCHLORIDE ALOXI INJECTABLE INTRAVENOUS EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) 8598219 RX
N021372 PALONOSETRON HYDROCHLORIDE ALOXI INJECTABLE INTRAVENOUS EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) 8598219*PED RX
N021572 DAPTOMYCIN CUBICIN POWDER IV (INFUSION) 250MG/VIAL 6468967 U-282 DISCN
N021572 DAPTOMYCIN CUBICIN POWDER INTRAVENOUS 500MG/VIAL 6468967 U-282 RX
N021572 DAPTOMYCIN CUBICIN POWDER IV (INFUSION) 250MG/VIAL 6852689 U-282 DISCN
N021572 DAPTOMYCIN CUBICIN POWDER INTRAVENOUS 500MG/VIAL 6852689 U-282 RX
N021572 DAPTOMYCIN CUBICIN POWDER IV (INFUSION) 250MG/VIAL 8058238 DISCN
N021572 DAPTOMYCIN CUBICIN POWDER INTRAVENOUS 500MG/VIAL 8058238 RX
N021572 DAPTOMYCIN CUBICIN POWDER INTRAVENOUS 500MG/VIAL 8129342 RX
N021572 DAPTOMYCIN CUBICIN POWDER INTRAVENOUS 500MG/VIAL 9138456 RX
N021720 DONEPEZIL HYDROCHLORIDE ARICEPT ODT TABLET, ORALLY DISINTEGRATING ORAL 5MG 7727548 U-1062 RX
N021720 DONEPEZIL HYDROCHLORIDE ARICEPT ODT TABLET, ORALLY DISINTEGRATING ORAL 10MG 7727548 U-1062 RX
N021720 DONEPEZIL HYDROCHLORIDE ARICEPT ODT TABLET, ORALLY DISINTEGRATING ORAL 5MG 7727552 RX
N021720 DONEPEZIL HYDROCHLORIDE ARICEPT ODT TABLET, ORALLY DISINTEGRATING ORAL 10MG 7727552 RX
N021959 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT TABLET, ORALLY DISINTEGRATING ORAL EQ 10MG BASE 6024981 RX
N021959 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT TABLET, ORALLY DISINTEGRATING ORAL EQ 15MG BASE 6024981 RX
N021959 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT TABLET, ORALLY DISINTEGRATING ORAL EQ 30MG BASE 6024981 RX
N021959 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT TABLET, ORALLY DISINTEGRATING ORAL EQ 10MG BASE 6221392 RX
N021959 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT TABLET, ORALLY DISINTEGRATING ORAL EQ 15MG BASE 6221392 RX
N021959 PREDNISOLONE SODIUM PHOSPHATE ORAPRED ODT TABLET, ORALLY DISINTEGRATING ORAL EQ 30MG BASE 6221392 RX
N022200 EXENATIDE SYNTHETIC BYDUREON FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/VIAL 8216180 RX
N022200 EXENATIDE SYNTHETIC BYDUREON FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/VIAL 8439864 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 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 30MG 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 30MG 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 30MG 7776314 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 7776314 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 7776314 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 8114383 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 10MG 8337888 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 15MG 8337888 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 20MG 8337888 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 30MG 8337888 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 40MG 8337888 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 60MG 8337888 RX
N022272 OXYCODONE HYDROCHLORIDE OXYCONTIN TABLET, EXTENDED RELEASE ORAL 80MG 8337888 RX
N022307 PRASUGREL HYDROCHLORIDE EFFIENT TABLET ORAL EQ 5MG BASE 6693115 U-991 RX
N022307 PRASUGREL HYDROCHLORIDE EFFIENT TABLET ORAL EQ 10MG BASE 6693115 U-991 RX
N022307 PRASUGREL HYDROCHLORIDE EFFIENT TABLET ORAL EQ 5MG BASE 6693115*PED RX
N022307 PRASUGREL HYDROCHLORIDE EFFIENT TABLET ORAL EQ 10MG BASE 6693115*PED RX
N022348 IBUPROFEN CALDOLOR SOLUTION INTRAVENOUS 400MG/4ML (100MG/ML) 9295639 U-1756 DISCN
N022405 VANDETANIB CAPRELSA TABLET ORAL 100MG 7173038 RX
N022405 VANDETANIB CAPRELSA TABLET ORAL 300MG 7173038 RX
N022405 VANDETANIB CAPRELSA TABLET ORAL 100MG 8642608 U-1490 RX
N022405 VANDETANIB CAPRELSA TABLET ORAL 300MG 8642608 U-1490 RX
N022472 INSULIN RECOMBINANT HUMAN AFREZZA POWDER INHALATION 4 UNITS/INH 8227409 U-1538 RX
N022472 INSULIN RECOMBINANT HUMAN AFREZZA POWDER INHALATION 8 UNITS/INH 8227409 U-1538 RX
N050803 CLINDAMYCIN PHOSPHATE; TRETINOIN VELTIN GEL TOPICAL 1.2%;0.025% 9492384 U-1412 RX
N202611 MIRABEGRON MYRBETRIQ TABLET, EXTENDED RELEASE ORAL 25MG 7750029 U-913 RX
N202611 MIRABEGRON MYRBETRIQ TABLET, EXTENDED RELEASE ORAL 50MG 7750029 U-913 RX
N205755 CERITINIB ZYKADIA CAPSULE ORAL 150MG 8039474 RX
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 5MG;10MG 7674799 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 10MG;20MG 7674799 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 20MG;40MG 7674799 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 5MG;10MG 7674800 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 10MG;20MG 7674800 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 20MG;40MG 7674800 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 5MG;10MG 7683072 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 10MG;20MG 7683072 DISCN
N205777 NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE TARGINIQ TABLET, EXTENDED RELEASE ORAL 20MG;40MG 7683072 DISCN
N207923 GLYCOPYRROLATE SEEBRI POWDER INHALATION 15.6MCG/INH 6582678 RX
N207930 GLYCOPYRROLATE ; INDACATEROL MALEATE UTIBRON POWDER INHALATION 15.6MCG/INH;27.5MCG/INH 6582678 RX

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View a list of all exclusivity codes

Last Updated March 28, 2017.

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