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	9447106	04/22/2034	DS	DP	U-1745 U-2145 U-2537 U-2666 U-3063 U-3486 U-3860	11/20/2019
001	10570139	04/22/2034			U-1745 U-2145 U-2537 U-2666 U-3063 U-3486 U-3860	06/04/2021
001	10927117	08/15/2037	DS	DP		04/20/2021
001	11142528	04/22/2034		DP	U-1745 U-2145 U-2537 U-2666 U-3063 U-3486 U-3860	11/12/2021
001	11591340	08/15/2037			U-1745 U-2145 U-2537 U-2666 U-3063 U-3486 U-3727 U-3728 U-3729	03/08/2023
001	11701357	06/24/2039			U-3860	04/02/2024
001	11786531	01/19/2043			U-3715 U-3716 U-3717 U-3718 U-3719 U-3720 U-3875	11/02/2023
001	11851437	08/15/2037	DS	DP		01/23/2024
001	11884674	08/15/2037			U-1745 U-2145 U-2537 U-2666 U-3063 U-3486 U-3860	02/28/2024
001	11896596	01/19/2043			U-3715 U-3716 U-3717 U-3718 U-3719 U-3720 U-3875	03/12/2024
001	11911386	01/19/2043			U-3715 U-3716 U-3717 U-3718 U-3719 U-3720 U-3875	02/28/2024