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	8436190	10/26/2030		DP		06/04/2013
001	8436190*PED	04/26/2031
001	8445524	03/26/2029	DS	DP	U-1402	06/04/2013
001	8445524*PED	09/26/2029
001	8609863	01/12/2026		DP		01/16/2014
001	8609863*PED	07/12/2026
001	8669279	03/26/2029		DP	U-1402	10/30/2014
001	8669279*PED	09/26/2029
001	8791270	01/12/2026		DP	U-1542	07/29/2014
001	8791270*PED	07/12/2026
001	8883836	03/26/2029		DP	U-1402	11/13/2014
001	8883836*PED	09/26/2029
001	8895756	01/12/2026		DP		11/26/2014
001	8895756*PED	07/12/2026
001	9533955	03/26/2029		DP	U-1949 U-1952
001	9533955*PED	09/26/2029

Product No	Exclusivity Code	Exclusivity Expiration