Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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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: N211243

Product 001
ESKETAMINE HYDROCHLORIDE (SPRAVATO) SPRAY EQ 28MG BASE

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8785500	03/05/2033			U-2502		04/03/2019
001	9592207	03/20/2027			U-2502		04/03/2019
001	10869844	09/10/2035			U-3034 U-3035 U-3036		01/15/2021
001	11173134	09/10/2035			U-3257 U-3536		12/16/2021
001	11311500	09/10/2035			U-3034 U-3035 U-3036		05/26/2022
001	11446260	03/14/2034			U-3444 U-3445 U-3446		10/14/2022
001	11883526	02/18/2040			U-3812 U-3813		02/16/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NCE*	03/05/2024

 

 

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