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
003	8470361	05/22/2030	DP	U-1425	07/10/2013
003	8658198	12/03/2027	DP	U-1494
003	8940330	09/18/2032	DP		02/05/2015
003	9259421	09/18/2032	DP		03/10/2016
003	9439900	09/18/2032	DP		10/03/2016
003	10946010	09/18/2032	DP		03/30/2021
003	11020387	09/18/2032	DP	U-3131	06/21/2021
003	11020388	09/18/2032	DP	U-3131	06/21/2021
003	11433066	09/18/2032		U-3131	09/20/2022

Product No	Exclusivity Code	Exclusivity Expiration