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	08/17/2016
001	8268349	08/25/2024		DP		08/17/2016
001	8399015	08/25/2024		DP		08/17/2016
001	8420596	04/10/2031	DS	DP		08/17/2016
001	8466159	09/04/2032			U-1637	08/17/2016
001	8492386	09/04/2032			U-1840	08/17/2016
001	8501238	09/17/2028	DS	DP	U-1636	08/17/2016
001	8642538	09/10/2029	DS	DP	U-1638	08/17/2016
001	8680106	09/04/2032			U-1637	08/17/2016
001	8685984	09/04/2032			U-1840	08/17/2016
001	8686026	06/09/2031		DP		08/17/2016
001	8691938	04/13/2032	DS	DP		08/17/2016
001	9006387	06/10/2030			U-1687	08/17/2016
001	9044480	04/10/2031			U-1638	08/17/2016
001	9139536	11/09/2028			U-1753	08/17/2016
001	9333204	01/02/2035		DP	U-1889	08/17/2016
001	9744170	01/02/2035		DP	U-1889	09/27/2017
001	10105365	01/02/2035		DP	U-1889	11/20/2018
001	10201541	05/17/2032		DP		03/14/2019
001	10201584	05/17/2032			U-1889	03/14/2019

Product No	Exclusivity Code	Exclusivity Expiration