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	7762994	05/23/2024		DP		03/29/2019
001	7762994*PED	11/23/2024
001	8114833	08/13/2025	DS	DP		03/13/2012
001	8114833*PED	02/13/2026
001	9265893	09/23/2032		DP		03/14/2016
001	9265893*PED	03/23/2033
001	9968659	01/09/2037			U-2313	06/12/2018
001	9968659*PED	07/09/2037

Product No	Exclusivity Code	Exclusivity Expiration