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	7253286	10/24/2025	DS	DP		03/10/2015
001	7253286*PED	04/24/2026
001	7612208	09/19/2026	DS	DP		03/10/2015
001	7612208*PED	03/19/2027
001	9006256	07/27/2027			U-1695	05/12/2015
001	9006256*PED	01/27/2028
001	10259791	08/26/2035	DS			05/13/2019
001	10259791*PED	02/26/2036
001	10407393	08/26/2035	DS			10/04/2019
001	10407393*PED	02/26/2036
001	11090386	02/23/2036			U-3519	02/10/2023
001	11090386*PED	08/23/2036
001	11186547	08/26/2035	DS			12/17/2021
001	11186547*PED	02/26/2036