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	8648037	01/19/2032	DS	DP	U-3238	07/08/2021
001	8648037*PED	07/19/2032
001	8937150	05/18/2032	DS	DP		07/08/2021
001	8937150*PED	11/18/2032
001	9321807	06/05/2035	DS	DP		07/08/2021
001	9321807*PED	12/05/2035
001	9586978	11/06/2030			U-3238	07/08/2021
001	9586978*PED	05/06/2031
001	10028937	06/10/2030			U-3238	07/08/2021
001	10028937*PED	12/10/2030
001	10039754	06/10/2030			U-3238	07/08/2021
001	10039754*PED	12/10/2030
001	10286029	03/14/2034			U-3238	07/08/2021
001	10286029*PED	09/14/2034
001	RE48923	05/08/2035	DS			03/08/2022
001	RE48923*PED	11/08/2035

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE-372	06/10/2028
001	ODE-372 *PED	12/10/2028