Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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.

Patent and Exclusivity for: N215309

Product 001
RUXOLITINIB PHOSPHATE (OPZELURA) CREAM EQ 1.5% BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	7598257	12/24/2027	DS	DP			10/20/2021
001	7598257*PED	06/24/2028
001	8415362	12/24/2027	DS	DP			10/20/2021
001	8415362*PED	06/24/2028
001	8722693	06/12/2028	DS	DP			10/20/2021
001	8722693*PED	12/12/2028
001	8822481	06/12/2028			U-3229 U-3404		10/20/2021
001	8822481*PED	12/12/2028
001	9079912	12/12/2026			U-3229 U-3404		10/20/2021
001	9079912*PED	06/12/2027
001	9974790	12/12/2026			U-3229 U-3404		10/20/2021
001	9974790*PED	06/12/2027
001	10610530	06/12/2028			U-3229 U-3404		10/20/2021
001	10610530*PED	12/12/2028
001	10639310	12/12/2026			U-3229		10/20/2021
001	10639310*PED	06/12/2027
001	10758543	05/20/2031		DP			10/20/2021
001	10758543*PED	11/20/2031
001	10869870	05/20/2031			U-3229 U-3404		10/20/2021
001	10869870*PED	11/20/2031
001	11219624	05/20/2031		DP	U-3229		02/08/2022
001	11219624*PED	11/20/2031
001	11510923	09/04/2040			U-3505		12/16/2022
001	11571425	05/20/2031		DP			02/28/2023
001	11590136	05/20/2031			U-3229 U-3404		03/28/2023
001	11590137	09/04/2040			U-3505		03/28/2023
001	11590138	06/10/2040			U-3551		03/28/2023
001	11602536	05/05/2041			U-3550		03/28/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NP	09/21/2024
001	NP *PED	03/21/2025
001	I-896	07/18/2025
001	I-896 *PED	01/18/2026

 

 

View a list of all patent use codes
View a list of all exclusivity codes