Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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.

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
N208564	ESTRADIOL	IMVEXXY	INSERT	VAGINAL	0.01MG	10537581	11/21/2032		DP	U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY		RX	02/13/2020
N208564	ESTRADIOL	IMVEXXY	INSERT	VAGINAL	0.01MG	10537581	11/21/2032		DP	U-2316 TREATMENT OF DYSPAREUNIA		RX	02/13/2020
N208564	ESTRADIOL	IMVEXXY	INSERT	VAGINAL	0.004MG	10537581	11/21/2032		DP	U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY		RX	02/13/2020
N208564	ESTRADIOL	IMVEXXY	INSERT	VAGINAL	0.004MG	10537581	11/21/2032		DP	U-2316 TREATMENT OF DYSPAREUNIA		RX	02/13/2020
N208573	VENETOCLAX	VENCLEXTA	TABLET	ORAL	50MG	8722657	01/29/2032	DS				RX	02/13/2020
N208573	VENETOCLAX	VENCLEXTA	TABLET	ORAL	100MG	8722657	01/29/2032	DS				RX	02/13/2020
N208573	VENETOCLAX	VENCLEXTA	TABLET	ORAL	10MG	8722657	01/29/2032	DS				RX	02/13/2020

Last Updated February 18, 2020.