Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Newly Added Patents

This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.

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.

31 records returned

Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No	Patent Expire Date	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Mkt. Status	Submission Date
Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No	Patent Expire Date	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Mkt. Status	Submission Date
N021829	ROTIGOTINE	NEUPRO	FILM, EXTENDED RELEASE	TRANSDERMAL	2MG/24HR	10350174	12/22/2030		DP			RX	07/18/2019
N021829	ROTIGOTINE	NEUPRO	FILM, EXTENDED RELEASE	TRANSDERMAL	4MG/24HR	10350174	12/22/2030		DP			RX	07/18/2019
N021829	ROTIGOTINE	NEUPRO	FILM, EXTENDED RELEASE	TRANSDERMAL	6MG/24HR	10350174	12/22/2030		DP			RX	07/18/2019
N021829	ROTIGOTINE	NEUPRO	FILM, EXTENDED RELEASE	TRANSDERMAL	1MG/24HR	10350174	12/22/2030		DP			RX	07/18/2019
N021829	ROTIGOTINE	NEUPRO	FILM, EXTENDED RELEASE	TRANSDERMAL	3MG/24HR	10350174	12/22/2030		DP			RX	07/18/2019
N021829	ROTIGOTINE	NEUPRO	FILM, EXTENDED RELEASE	TRANSDERMAL	8MG/24HR	10350174	12/22/2030		DP			RX	07/18/2019
N201688	TOBRAMYCIN	TOBI PODHALER	POWDER	INHALATION	28MG	10207066	11/04/2030		DP	U-909		RX	06/17/2019
N201688	TOBRAMYCIN	TOBI PODHALER	POWDER	INHALATION	28MG	8664187	06/20/2025			U-909		RX	06/17/2019
N201688	TOBRAMYCIN	TOBI PODHALER	POWDER	INHALATION	28MG	8869794	09/12/2028		DP	U-909		RX	06/17/2019
N201688	TOBRAMYCIN	TOBI PODHALER	POWDER	INHALATION	28MG	9421166	12/19/2022		DP	U-909		RX	06/17/2019
N202880	HYDROCODONE BITARTRATE	ZOHYDRO ER	CAPSULE, EXTENDED RELEASE	ORAL	10MG	10322120	07/25/2033		DP			RX	07/17/2019
N202880	HYDROCODONE BITARTRATE	ZOHYDRO ER	CAPSULE, EXTENDED RELEASE	ORAL	15MG	10322120	07/25/2033		DP			RX	07/17/2019
N202880	HYDROCODONE BITARTRATE	ZOHYDRO ER	CAPSULE, EXTENDED RELEASE	ORAL	20MG	10322120	07/25/2033		DP			RX	07/17/2019
N202880	HYDROCODONE BITARTRATE	ZOHYDRO ER	CAPSULE, EXTENDED RELEASE	ORAL	30MG	10322120	07/25/2033		DP			RX	07/17/2019
N202880	HYDROCODONE BITARTRATE	ZOHYDRO ER	CAPSULE, EXTENDED RELEASE	ORAL	40MG	10322120	07/25/2033		DP			RX	07/17/2019
N202880	HYDROCODONE BITARTRATE	ZOHYDRO ER	CAPSULE, EXTENDED RELEASE	ORAL	50MG	10322120	07/25/2033		DP			RX	07/17/2019
N203684	SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES	LUMASON	FOR SUSPENSION	INTRAVENOUS	60.7MG/25MG	10335502	07/06/2038		DP			RX	07/16/2019
N207589	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	ENSTILAR	AEROSOL, FOAM	TOPICAL	0.064%;0.005%	10130640	06/10/2031		DP			RX	12/06/2018
N207589	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	ENSTILAR	AEROSOL, FOAM	TOPICAL	0.064%;0.005%	10130640*PED	12/10/2031					RX
N207589	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	ENSTILAR	AEROSOL, FOAM	TOPICAL	0.064%;0.005%	9119781	06/10/2031		DP	U-1761		RX	11/12/2015
N207589	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	ENSTILAR	AEROSOL, FOAM	TOPICAL	0.064%;0.005%	9119781*PED	12/10/2031					RX
N209091	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	QTERN	TABLET	ORAL	10MG;EQ 5MG BASE	6414126	10/04/2020	DS	DP	U-493		RX	03/22/2017
N209091	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	QTERN	TABLET	ORAL	10MG;EQ 5MG BASE	6515117	10/04/2020	DS	DP	U-493		RX	03/22/2017
N209091	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	QTERN	TABLET	ORAL	10MG;EQ 5MG BASE	RE44186	07/31/2023	DS	DP	U-493		RX	03/22/2017
N209360	ANGIOTENSIN II ACETATE	GIAPREZA	SOLUTION	INTRAVENOUS	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	9572856	11/20/2030			U-2221		RX	01/22/2018
N209360	ANGIOTENSIN II ACETATE	GIAPREZA	SOLUTION	INTRAVENOUS	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	9572856	11/20/2030			U-2221		DISCN	01/22/2018
N209449	NITISINONE	NITYR	TABLET	ORAL	2MG	10328029	01/05/2035		DP	U-1836		RX	07/17/2019
N209449	NITISINONE	NITYR	TABLET	ORAL	5MG	10328029	01/05/2035		DP	U-1836		RX	07/17/2019
N209449	NITISINONE	NITYR	TABLET	ORAL	10MG	10328029	01/05/2035		DP	U-1836		RX	07/17/2019
N209589	CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE	CLENPIQ	SOLUTION	ORAL	12GM/BOT;3.5GM/BOT;10MG/BOT	9827231	06/26/2034		DP	U-2162		RX	12/06/2017
N210598	REVEFENACIN	YUPELRI	SOLUTION	INHALATION	175MCG/3ML	10343995	03/10/2025			U-2440		RX	07/15/2019

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

Last Updated July 19, 2019.