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	7700645	12/26/2026	DS	DP		02/26/2015
001	7700645*PED	06/26/2027
001	8148374	09/03/2029	DS	DP	U-1279 U-2939	02/26/2015
001	8518987	02/16/2024	DS	DP		02/26/2015
001	8518987*PED	08/16/2024
001	10039718	10/06/2032		DP		09/05/2018

Product No	Exclusivity Code	Exclusivity Expiration