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 Substance	Drug Product	Patent Use Code	Submission Date
001	7851504	06/13/2027	DS	DP
001	8278353	03/16/2025		DP		10/02/2012
001	8299118	03/16/2025			U-1295	11/16/2012
001	8309605	03/16/2025			U-1293 U-1294	11/16/2012
001	8338479	03/16/2025		DP	U-1295	12/26/2012
001	8524777	03/16/2025			U-1235	10/02/2013
001	8586630	03/16/2025			U-1458
001	8772338	03/16/2025		DP	U-1528	07/21/2014
001	8933120	03/16/2025		DP		02/10/2015
001	8933127	03/16/2025		DP		02/10/2015
001	9155716	03/16/2025		DP	U-1528	11/12/2015
001	9241918	03/16/2025		DP	U-1814	02/24/2016

Product No	Exclusivity Code	Exclusivity Expiration