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	8188104	05/17/2029	DS	DP	U-1636	01/15/2015
001	8268349	08/25/2024		DP		01/15/2015
001	8399015	08/25/2024		DP		01/15/2015
001	8420596	04/10/2031	DS	DP		01/15/2015
001	8466159	09/04/2032			U-1637	01/15/2015
001	8492386	09/04/2032			U-1840	01/15/2015
001	8501238	12/19/2028	DS	DP	U-1636	01/15/2015
001	8642538	09/10/2029	DS	DP	U-1638	01/15/2015
001	8680106	09/04/2032			U-1637	01/15/2015
001	8685984	09/04/2032			U-1840	01/15/2015
001	8686026	06/09/2031		DP		01/15/2015
001	8691938	04/13/2032	DS	DP		01/15/2015
001	9006387	06/10/2030			U-1687	05/06/2015
001	9044480	04/10/2031			U-1638	07/01/2015
001	9139536	11/09/2028			U-1753	10/21/2015
001	9629841	10/18/2033		DP	U-1753	06/16/2017
001	10201542	10/18/2033		DP	U-1753	03/14/2019

Product No	Exclusivity Code	Exclusivity Expiration