Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Delisted Patents

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

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.