Details for New Drug Application (NDA): 211746
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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
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
Physiological Effect | Decreased Histamine Release |
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: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.025MG/SPRAY;0.665MG/SPRAY | ||||
Approval Date: | Jan 13, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jan 13, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 4, 2034 | Product 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 Up | Patent Expiration: | Sep 4, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? |
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