Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Additional Information about Patents

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.

Product No	Patent No	Patent Expiration	Drug Product	Patent Use Code	Submission Date
001	8217078	07/10/2029		U-1477	02/25/2014
001	8252838	04/21/2028	DP	U-1489	02/25/2014
001	8546450	08/09/2030		U-1435 U-1436	02/25/2014
001	8563613	10/17/2027	DP	U-1488	02/25/2014
001	8618164	07/10/2029		U-1477	02/25/2014
001	8741956	07/10/2029		U-1435	06/05/2014
001	8871809	10/17/2027		U-1614	11/18/2014
001	9066913	10/17/2027	DP	U-1488	06/30/2015
001	9101591	10/17/2027	DP	U-1488	08/11/2015
001	9132110	10/17/2027		U-1488	09/16/2015
001	9168304	10/17/2027	DP		10/27/2015
001	9168305	10/17/2027		U-1488	10/27/2015
001	9220784	10/17/2027		U-1488	01/28/2016
001	9339551	10/17/2027		U-1488	06/16/2016
001	9339552	10/17/2027	DP	U-1488	06/16/2016
001	9370501	07/10/2029		U-1614	07/19/2016
001	9375412	07/10/2029		U-1614	07/26/2016
001	9415029	07/10/2029		U-1614	09/13/2016
001	9539335	10/17/2027		U-1614	02/06/2016

Product No	Exclusivity Code	Exclusivity Expiration