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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 211746


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NDA 211746 describes RYALTRIS, which is a drug marketed by Glenmark Speclt and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the RYALTRIS profile page.

The generic ingredient in RYALTRIS is mometasone furoate; olopatadine hydrochloride. There are thirty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mometasone furoate; olopatadine hydrochloride profile page.
Summary for 211746
Tradename:RYALTRIS
Applicant:Glenmark Speclt
Ingredient:mometasone furoate; olopatadine hydrochloride
Patents:15
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211746
Generic Entry Date for 211746*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
SPRAY, METERED;NASAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 211746
Suppliers and Packaging for NDA: 211746
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RYALTRIS mometasone furoate; olopatadine hydrochloride SPRAY, METERED;NASAL 211746 NDA HIKMA SPECIALTY USA INC. 59467-700 59467-700-27 12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY
RYALTRIS mometasone furoate; olopatadine hydrochloride SPRAY, METERED;NASAL 211746 NDA HIKMA SPECIALTY USA INC. 59467-700 59467-700-84 12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.025MG/SPRAY;0.665MG/SPRAY
Approval Date:Jan 13, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 13, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Sep 4, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE
Patent:⤷  Sign UpPatent Expiration:Sep 4, 2034Product Flag?YSubstance Flag?Delist Request?

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