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.

15 records returned

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
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	60MG	6559188	U-827	RX
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	120MG	6559188	U-827	RX
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	60MG	6878749		RX
N021204	NATEGLINIDE	STARLIX	TABLET	ORAL	120MG	6878749		RX
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7410978		DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7759359	U-1071	DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7763635	U-1071	DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7781448	U-1071	DISCN
N022103	TROSPIUM CHLORIDE	SANCTURA XR	CAPSULE, EXTENDED RELEASE	ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	7781449	U-1071	DISCN
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995	U-1306	DISCN	12/11/2012
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995	U-1575	DISCN	12/11/2012
N022291	ELTROMBOPAG OLAMINE	PROMACTA	TABLET	ORAL	EQ 100MG ACID	8052995*PED		DISCN
N205636	ALBUTEROL SULFATE	PROAIR RESPICLICK	POWDER, METERED	INHALATION	EQ 0.09MG BASE/INH	9782550		RX	01/09/2019
N205636	ALBUTEROL SULFATE	PROAIR RESPICLICK	POWDER, METERED	INHALATION	EQ 0.09MG BASE/INH	9782551		RX	01/09/2019
N210361	GLYCOPYRRONIUM TOSYLATE	QBREXZA	CLOTH	TOPICAL	EQ 2.4% BASE	9006462		RX	09/20/2018

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

Last Updated March 22, 2019.