Details for New Drug Application (NDA): 218585
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NDA 218585 describes VIZZ, which is a drug marketed by Lenz Therap and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the VIZZ profile page.
The generic ingredient in VIZZ is aceclidine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aceclidine hydrochloride profile page.
The generic ingredient in VIZZ is aceclidine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aceclidine hydrochloride profile page.
Summary for 218585
| Tradename: | VIZZ |
| Applicant: | Lenz Therap |
| Ingredient: | aceclidine hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218585
Generic Entry Date for 218585*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 218585
| Mechanism of Action | Cholinergic Muscarinic Agonists |
Suppliers and Packaging for NDA: 218585
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIZZ | aceclidine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 218585 | NDA | LENZ Therapeutics, Inc. | 84226-100 | 84226-100-11 | 5 POUCH in 1 CARTON (84226-100-11) / 5 AMPULE in 1 POUCH (84226-100-01) / .4 mL in 1 AMPULE |
| VIZZ | aceclidine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 218585 | NDA | LENZ Therapeutics, Inc. | 84226-100 | 84226-100-21 | 5 POUCH in 1 CARTON (84226-100-21) / 5 AMPULE in 1 POUCH (84226-100-02) / .25 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 1.44% BASE | ||||
| Approval Date: | Jul 31, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 31, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,052,313 | Patent Expiration: | Mar 24, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
| Patent: | 11,179,328 | Patent Expiration: | Mar 24, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRESBYOPIA | ||||||||
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