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
003	8426586	10/10/2029	DS			08/01/2013
003	8426586*PED	04/10/2030
003	8545884	12/19/2029		DP		10/28/2013
003	8545884*PED	06/19/2030
003	9539258	11/09/2026			U-1950	02/02/2017
003	9539258*PED	05/09/2027
003	10004743	07/05/2030		DP		08/02/2018
003	10004743*PED	01/05/2031
003	RE43431	01/13/2026	DS			08/01/2013
003	RE43431*PED	07/13/2026