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 Product	Patent Use Code	Submission Date
001	8026284	09/22/2027		U-1399	03/13/2020
001	8026284*PED	03/22/2028
001	9173851	06/17/2034	DP		03/13/2020
001	9173851*PED	12/17/2034
001	9192590	01/26/2027		U-1399	03/13/2020
001	9192590*PED	07/26/2027
001	9198882	01/26/2027		U-1399	03/13/2020
001	9198882*PED	07/26/2027
001	9233077	06/17/2034	DP		03/13/2020
001	9233077*PED	12/17/2034
001	9925156	01/26/2027	DP	U-1399	03/13/2020
001	9925156*PED	07/26/2027
001	9925157	01/26/2027	DP	U-1399	03/13/2020
001	9925157*PED	07/26/2027
001	9925158	01/26/2027	DP	U-1399	03/13/2020
001	9925158*PED	07/26/2027
001	10143665	08/16/2036		U-1399	03/13/2020
001	10143665*PED	02/16/2037
001	10328037	08/16/2036		U-1399	03/13/2020
001	10328037*PED	02/16/2037
001	10548859	08/16/2036		U-1399	03/13/2020
001	10548859*PED	02/16/2037
001	10905662	08/16/2036		U-1399	03/02/2021
001	10905662*PED	02/16/2037

Product No	Exclusivity Code	Exclusivity Expiration
001	ODE*	12/22/2024
001	ODE* *PED	06/22/2025