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 Product	Patent Use Code	Submission Date
003	7566729	04/22/2029		U-2077 U-2078	02/10/2017
003	7635707	04/22/2029		U-2072 U-2073 U-2074 U-2075 U-2076 U-2083	02/10/2017
003	7767700	12/18/2027		U-2080	02/10/2017
003	7816383	01/08/2030		U-2042 U-2050	02/10/2017
003	7910610	01/08/2030		U-2048 U-2049	02/10/2017
003	8013002	01/08/2030		U-2047 U-2082	02/10/2017
003	8084475	01/08/2030		U-2052 U-2054	02/10/2017
003	8318780	01/08/2030		U-2046 U-2081	02/10/2017
003	8383150	05/10/2028	DP	U-2361	02/10/2017
003	8420674	12/18/2027		U-2079	02/10/2017
003	8592462	04/22/2029		U-2055 U-2056 U-2057 U-2058 U-2059 U-2060 U-2061 U-2062 U-2063	02/10/2017
003	8609701	04/22/2029		U-2064 U-2065 U-2066 U-2067 U-2068 U-2069 U-2070	02/10/2017
003	8648098	01/08/2030		U-2051 U-2052	02/10/2017
003	8754109	01/08/2030		U-2053	02/10/2017
003	8778947	08/30/2033		U-2044 U-2045	02/10/2017
003	10188637	03/28/2037	DP		02/25/2019

Product No	Exclusivity Code	Exclusivity Expiration