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
003	7495103	05/20/2027	DS	DP		09/26/2022
003	7973038	11/08/2026			U-3424	09/26/2022
003	8324242	08/05/2027			U-3424	09/26/2022
003	8410274	12/28/2026		DP		09/26/2022
003	8507534	09/20/2030	DS	DP		09/26/2022
003	8653103	12/04/2028		DP		09/26/2022
003	8716338	09/20/2030		DP	U-3426	09/26/2022
003	8741933	11/08/2026			U-3424	09/26/2022
003	8754224	12/28/2026	DS	DP		09/26/2022
003	8846718	07/02/2029			U-3427	09/26/2022
003	8993600	12/11/2030		DP		09/26/2022
003	9150552	12/04/2028			U-3427	09/26/2022
003	9192606	09/29/2029		DP	U-3428	09/26/2022
003	9216969	11/08/2026		DP		09/26/2022
003	9670163	12/28/2026		DP	U-3429	09/26/2022
003	9931334	12/28/2026		DP	U-3429	09/26/2022
003	10597384	12/04/2028	DS	DP	U-3430	09/26/2022
003	10646481	08/13/2029		DP		09/26/2022
003	11564916	08/13/2029			U-3526	02/28/2023

Product No	Exclusivity Code	Exclusivity Expiration
003	NS	09/02/2025
003	ODE-408	09/02/2029