Details for New Drug Application (NDA): 215092
✉ Email this page to a colleague
NDA 215092 describes OMLONTI, which is a drug marketed by Ocuvex Therap and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the OMLONTI profile page.
The generic ingredient in OMLONTI is omidenepag isopropyl. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the omidenepag isopropyl profile page.
The generic ingredient in OMLONTI is omidenepag isopropyl. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the omidenepag isopropyl profile page.
Summary for 215092
| Tradename: | OMLONTI |
| Applicant: | Ocuvex Therap |
| Ingredient: | omidenepag isopropyl |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215092
Generic Entry Date for 215092*:
Constraining patent/regulatory exclusivity:
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 | Ocuvex Therapeutics, Inc. | 84826-002 | 84826-002-01 | 1 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC |
| OMLONTI | omidenepag isopropyl | SOLUTION;OPHTHALMIC | 215092 | NDA | Ocuvex Therapeutics, Inc. | 84826-002 | 84826-002-03 | 3 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | 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: | ⤷ Start Trial | 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: | ⤷ Start Trial | 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 | ||||||||
Complete Access Available with Subscription
