Details for New Drug Application (NDA): 215092
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The generic ingredient in OMLONTI is omidenepag isopropyl. One supplier is listed for this compound. Additional details are available on the omidenepag isopropyl profile page.
Summary for 215092
Tradename: | OMLONTI |
Applicant: | Visiox Pharma |
Ingredient: | omidenepag isopropyl |
Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215092
Generic Entry Date for 215092*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;OPHTHALMIC |
*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: 215092
Mechanism of Action | Prostaglandin E2 Receptor Agonists |
Suppliers and Packaging for NDA: 215092
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMLONTI | omidenepag isopropyl | SOLUTION;OPHTHALMIC | 215092 | NDA | Santen Incorporated | 65086-002 | 65086-002-01 | 1 BOTTLE, PLASTIC in 1 CARTON (65086-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC |
OMLONTI | omidenepag isopropyl | SOLUTION;OPHTHALMIC | 215092 | NDA | Santen Incorporated | 65086-002 | 65086-002-05 | 1 BOTTLE, PLASTIC in 1 CARTON (65086-002-05) / 2.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;OPHTHALMIC | Strength | 0.002% | ||||
Approval Date: | Sep 22, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Sep 22, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 8, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 8, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION IN PATIENTS |
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