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.

38 records returned

Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No	Patent Expiration Date	Drug Substance Claim	Drug Product Claim	Patent Use Code	Delist Requested	Mkt. Status
Appl No	Active Ingredient	Proprietary Name	Dosage Form	Route	Strength	Patent No	Patent Expiration Date	Drug Substance Claim	Drug Product Claim	Patent Use Code	Delist Requested	Mkt. Status
N021937	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	ATRIPLA	TABLET	ORAL	600MG;200MG;300MG	8598185	Apr 28, 2029		DP			RX
N202324	AXITINIB	INLYTA	TABLET	ORAL	1MG	8791140	Dec 14, 2030	DS				RX
N202324	AXITINIB	INLYTA	TABLET	ORAL	5MG	8791140	Dec 14, 2030	DS				RX
N204820	COLCHICINE	MITIGARE	CAPSULE	ORAL	0.6MG	9675613	Aug 22, 2033			U-1020		RX
N205755	CERITINIB	ZYKADIA	CAPSULE	ORAL	150MG	8188276	Jan 31, 2023	DS	DP			RX
N205755	CERITINIB	ZYKADIA	CAPSULE	ORAL	150MG	8399450	Nov 20, 2027	DS	DP			RX
N205755	CERITINIB	ZYKADIA	CAPSULE	ORAL	150MG	8835430	Jan 31, 2023	DS	DP			RX
N205755	CERITINIB	ZYKADIA	CAPSULE	ORAL	150MG	9018204	Jan 31, 2023	DS	DP			RX
N205755	CERITINIB	ZYKADIA	CAPSULE	ORAL	150MG	9416112	Jan 31, 2023	DS	DP			RX
N206619	DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR	VIEKIRA PAK (COPACKAGED)	TABLET, TABLET	ORAL	EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG	9629841	Oct 18, 2033		DP	U-1753		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	20MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	30MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	40MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	60MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	80MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	100MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	120MG	9669023	Oct 30, 2020		DP			RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	20MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	30MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	40MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	60MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	80MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	100MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	120MG	9675611	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	20MG	9682077	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	30MG	9682077	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	40MG	9682077	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	60MG	9682077	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	80MG	9682077	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	100MG	9682077	Oct 30, 2020			U-1556		RX
N206627	HYDROCODONE BITARTRATE	HYSINGLA	TABLET, EXTENDED RELEASE	ORAL	120MG	9682077	Oct 30, 2020			U-1556		RX
N208026	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	JENTADUETO XR	TABLET, EXTENDED RELEASE	ORAL	2.5MG;1GM	8846695	Jun 4, 2030			U-1503		RX
N208079	BETAMETHASONE DIPROPIONATE	SERNIVO	SPRAY	TOPICAL	EQ 0.05% BASE/SPRAY	9655907	Aug 31, 2030		DP	U-1858		RX
N208090	OXYCODONE	XTAMPZA ER	CAPSULE, EXTENDED RELEASE	ORAL	9MG	9682075	Dec 10, 2030		DP	U-1556		RX
N208090	OXYCODONE	XTAMPZA ER	CAPSULE, EXTENDED RELEASE	ORAL	13.5MG	9682075	Dec 10, 2030		DP	U-1556		RX
N208090	OXYCODONE	XTAMPZA ER	CAPSULE, EXTENDED RELEASE	ORAL	18MG	9682075	Dec 10, 2030		DP	U-1556		RX
N208090	OXYCODONE	XTAMPZA ER	CAPSULE, EXTENDED RELEASE	ORAL	27MG	9682075	Dec 10, 2030		DP	U-1556		RX
N208090	OXYCODONE	XTAMPZA ER	CAPSULE, EXTENDED RELEASE	ORAL	36MG	9682075	Dec 10, 2030		DP	U-1556		RX

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

Last Updated June 23, 2017.