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	7893074	04/25/2026	DS	DP		05/13/2014
001	7964592	04/29/2028	DS	DP		05/13/2014
001	8039479	06/29/2030	DS	DP		05/13/2014
001	8377921	11/20/2027			U-1179	05/23/2014
001	8399450	11/20/2027	DS	DP		06/15/2017
001	8703787	02/02/2032			U-1179	05/23/2014
001	9309229	01/18/2032	DS	DP		04/22/2016

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-145	05/26/2024