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: N211746

Product 001
MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE (RYALTRIS) SPRAY, METERED 0.025MG/SPRAY;0.665MG/SPRAY

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	9078923	09/04/2034		DP	U-3297		02/11/2022
001	9370483	09/04/2034		DP			02/11/2022
001	9750754	09/04/2034		DP	U-3297		02/11/2022
001	9937189	09/04/2034		DP			02/11/2022
001	10016443	09/04/2034			U-3297		02/11/2022
001	10376526	09/04/2034		DP			02/11/2022
001	10517880	09/04/2034		DP	U-3297		02/11/2022
001	10548907	09/04/2034			U-3297		02/11/2022
001	10561672	09/04/2034		DP			02/11/2022
001	10646500	09/04/2034			U-3297		02/11/2022
001	10758550	09/04/2034			U-3296		02/11/2022
001	10765686	09/04/2034			U-3295		02/11/2022
001	11400101	09/04/2034			U-3297		08/25/2022
001	11679210	09/03/2038		DP			07/20/2023

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration
001	NP	01/13/2025

 

 

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