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
001	7566729	04/22/2029		U-1600	11/14/2014
001	7635707	04/22/2029		U-1609	11/14/2014
001	7696236	12/18/2027		U-1601	11/14/2014
001	7767225	09/22/2026	DP	U-1602	11/14/2014
001	7767700	12/18/2027		U-1601	11/14/2014
001	7816383	01/08/2030		U-1603	11/14/2014
001	7910610	01/08/2030		U-1604	11/14/2014
001	7988994	09/22/2026	DP	U-1602	11/14/2014
001	8013002	01/08/2030		U-1603	11/14/2014
001	8084475	01/08/2030		U-1605	11/14/2014
001	8318780	01/08/2030		U-1606	11/14/2014
001	8383150	05/10/2028	DP	U-2361	11/14/2014
001	8420674	12/18/2027	DP	U-1608	11/14/2014
001	8592462	04/22/2029		U-1609	11/14/2014
001	8609701	04/22/2029		U-1610	11/14/2014
001	8648098	01/08/2030		U-1611	11/14/2014
001	8753679	09/22/2026	DP	U-1602	11/14/2014
001	8754109	01/08/2030		U-1612	11/14/2014
001	8778947	08/30/2033		U-1613	11/14/2014

Product No	Exclusivity Code	Exclusivity Expiration