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.
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: | 10,016,443 | 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: | 10,376,526 | Patent Expiration: | Sep 4, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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