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	7449464	09/08/2027	DS	DP		09/15/2017
001	7981889	10/11/2024	DS	DP		09/15/2017
001	8071579	08/12/2027			U-2480 U-2482 U-2483 U-2716 U-2819 U-2820 U-2821 U-2822 U-2823 U-2824 U-2832 U-2833 U-3333 U-3631 U-3695	06/18/2020
001	8143241	08/12/2027			U-2480 U-2482 U-2483 U-2716 U-2819 U-2820 U-2821 U-2822 U-2823 U-2824 U-2832 U-2833 U-3333 U-3631 U-3695	09/15/2017
001	8475842	12/31/2029		DP		09/15/2017
001	8859562	08/04/2031			U-2101 U-2103 U-2480 U-2482 U-2483 U-2716 U-2819 U-2820 U-2821 U-2822 U-2823 U-2824 U-2832 U-2833 U-3333 U-3631 U-3695	09/15/2017
001	8912187	03/12/2024			U-2480 U-2482 U-2483 U-2819 U-2820 U-2821 U-2822 U-2823 U-2824 U-3333 U-3695	09/15/2017
001	9169235	03/12/2024			U-2832 U-2833 U-3631	06/18/2020
001	9566276	03/12/2024			U-2716	01/22/2020
001	11633396	10/07/2029		DP		05/19/2023