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	7579449	08/01/2028	DS			08/15/2014
001	7579449*PED	02/01/2029
001	7713938	04/15/2027	DS	DP		08/15/2014
001	7713938*PED	10/15/2027
001	8551957	10/14/2029			U-1651	03/14/2016
001	8551957*PED	04/14/2030
001	9949997	05/17/2034			U-2292 U-3199 U-3325	05/15/2018
001	9949997*PED	11/17/2034
001	9949998	06/11/2034			U-2290	05/15/2018
001	9949998*PED	12/11/2034
001	10258637	04/03/2034			U-2290	04/30/2019
001	10258637*PED	10/03/2034
001	11090323	04/03/2034			U-3191	08/20/2021
001	11090323*PED	10/03/2034
001	11666590	04/03/2034			U-3691	10/03/2023
001	11813275	04/03/2034			U-3759 U-3760	12/13/2023
001	11833166	04/03/2034			U-3776 U-3777	01/03/2024