Details for New Drug Application (NDA): 220142
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NDA 220142 describes YUVEZZI, which is a drug marketed by Visus and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the YUVEZZI profile page.
The generic ingredient in YUVEZZI is brimonidine tartrate; carbachol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; carbachol profile page.
The generic ingredient in YUVEZZI is brimonidine tartrate; carbachol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brimonidine tartrate; carbachol profile page.
Summary for 220142
| Tradename: | YUVEZZI |
| Applicant: | Visus |
| Ingredient: | brimonidine tartrate; carbachol |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220142
Generic Entry Date for 220142*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SOLUTION/DROPS;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: 220142
| Mechanism of Action | Adrenergic alpha-Agonists Cholinergic Agonists |
Suppliers and Packaging for NDA: 220142
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YUVEZZI | brimonidine tartrate; carbachol | SOLUTION/DROPS;OPHTHALMIC | 220142 | NDA | Visus Therapeutics, Inc. | 84892-275 | 84892-275-30 | 6 POUCH in 1 CARTON (84892-275-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01) |
| YUVEZZI | brimonidine tartrate; carbachol | SOLUTION/DROPS;OPHTHALMIC | 220142 | NDA | Visus Therapeutics, Inc. | 84892-275 | 84892-275-99 | 1 POUCH in 1 CARTON (84892-275-99) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.1%;2.75% | ||||
| Approval Date: | Jan 28, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 28, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 12,268,662 | Patent Expiration: | Nov 10, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
| Patent: | 12,268,662 | Patent Expiration: | Nov 10, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PRESBYOPIA IN ADULTS BY ADMINISTRATION OF BRIMONIDINE AND CARBACHOL ONCE DAILY | ||||||||
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