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.

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
N020800 EPINEPHRINE ADRENACLICK INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS EQ 0.15MG/DELIVERY 10166344
RX 11/15/2019
N020800 EPINEPHRINE ADRENACLICK INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS EQ 0.3MG/DELIVERY 10166344
RX 11/15/2019
N204629 EMPAGLIFLOZIN JARDIANCE TABLET ORAL 25MG 10406172
U-1652 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
RX 09/30/2019
N204629 EMPAGLIFLOZIN JARDIANCE TABLET ORAL 10MG 10406172
U-1652 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
RX 09/30/2019
N206073 EMPAGLIFLOZIN; LINAGLIPTIN GLYXAMBI TABLET ORAL 25MG;5MG 10406172
U-1652 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
RX 09/30/2019
N206073 EMPAGLIFLOZIN; LINAGLIPTIN GLYXAMBI TABLET ORAL 10MG;5MG 10406172
U-1652 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
RX 09/30/2019
N022200 EXENATIDE SYNTHETIC BYDUREON PEN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG 7851502
RX 11/15/2017
N022200 EXENATIDE SYNTHETIC BYDUREON PEN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG 7919598
RX 11/15/2017
N022200 EXENATIDE SYNTHETIC BYDUREON PEN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG 8221786
RX 11/15/2017
N020622 GLATIRAMER ACETATE COPAXONE INJECTABLE SUBCUTANEOUS 40MG/ML 8232250
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
RX 02/26/2014
N020622 GLATIRAMER ACETATE COPAXONE INJECTABLE SUBCUTANEOUS 40MG/ML 8399413
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
RX 02/26/2014
N022200 EXENATIDE SYNTHETIC BYDUREON PEN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG 8685934
U-1522 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
RX 11/15/2017
N022200 EXENATIDE SYNTHETIC BYDUREON PEN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG 8716251
RX 11/15/2017
N020622 GLATIRAMER ACETATE COPAXONE INJECTABLE SUBCUTANEOUS 40MG/ML 8969302
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
RX 03/03/2015
N020622 GLATIRAMER ACETATE COPAXONE INJECTABLE SUBCUTANEOUS 40MG/ML 9155776
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
RX 10/13/2015
N020622 GLATIRAMER ACETATE COPAXONE INJECTABLE SUBCUTANEOUS 40MG/ML 9402874
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
RX 08/02/2016

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

Last Updated February 18, 2020.

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