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	Patent Use Code	Submission Date
001	7601758	02/10/2029	U-1007
001	7619004	12/03/2028	U-1020
001	7820681	02/17/2029	U-1020
001	7906519	02/17/2029	U-1116
001	7915269	02/17/2029	U-1007
001	7935731	12/03/2028	U-1116	06/24/2011
001	7964647	10/06/2028	U-1007	06/24/2011
001	7964648	10/06/2028	U-1161	06/24/2011
001	7981938	10/06/2028	U-1166	07/22/2011
001	8093296	10/06/2028	U-1007	01/13/2012
001	8093297	10/06/2028	U-1161	01/13/2012
001	8093298	10/06/2028	U-1116	01/13/2012
001	8097655	10/06/2028	U-1020	01/27/2012
001	8415395	10/06/2028	U-1007	05/08/2013
001	8415396	10/06/2028	U-1007	05/08/2013
001	8440721	02/17/2029	U-1007	06/10/2013
001	8440722	02/17/2029	U-1020	06/10/2013

Product No	Exclusivity Code	Exclusivity Expiration