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	Submission Date
007	8651103	03/26/2028	DP	08/05/2021
007	8651103*PED	09/26/2028
007	8714149	02/25/2032	DP	08/05/2021
007	8714149*PED	08/25/2032
007	8978966	01/13/2032	DP	08/05/2021
007	8978966*PED	07/13/2032
007	9216260	06/28/2031	DP	08/05/2021
007	9216260*PED	12/28/2031
007	9463288	05/19/2025	DP	08/05/2021
007	9463288*PED	11/19/2025
007	9616024	09/01/2024	DP	08/05/2021
007	9616024*PED	03/01/2025
007	9731087	05/18/2031	DP	08/05/2021
007	9731087*PED	11/18/2031
007	10022510	05/18/2031	DP	08/05/2021
007	10022510*PED	11/18/2031
007	10124131	05/18/2031	DP	08/05/2021
007	10124131*PED	11/18/2031
007	10195375	02/14/2031	DP	08/05/2021
007	10195375*PED	08/14/2031
007	10561808	01/01/2032	DP	08/05/2021
007	10561808*PED	07/01/2032
007	10765820	05/19/2025	DP	08/05/2021
007	10765820*PED	11/19/2025

Product No	Exclusivity Code	Exclusivity Expiration
007	NS	07/09/2024
007	NS *PED	01/09/2025