Details for New Drug Application (NDA): 207795
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NDA 207795 describes VYZULTA, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VYZULTA profile page.
The generic ingredient in VYZULTA is latanoprostene bunod. One supplier is listed for this compound. Additional details are available on the latanoprostene bunod profile page.
The generic ingredient in VYZULTA is latanoprostene bunod. One supplier is listed for this compound. Additional details are available on the latanoprostene bunod profile page.
Summary for 207795
| Tradename: | VYZULTA |
| Applicant: | Bausch And Lomb |
| Ingredient: | latanoprostene bunod |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207795
Generic Entry Date for 207795*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 207795
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795 | NDA | Bausch & Lomb Incorporated | 24208-504 | 24208-504-01 | 1 BOTTLE in 1 CARTON (24208-504-01) / 2.5 mL in 1 BOTTLE |
| VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795 | NDA | Bausch & Lomb Incorporated | 24208-504 | 24208-504-02 | 1 BOTTLE in 1 CARTON (24208-504-02) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.024% | ||||
| Approval Date: | Nov 2, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 7,273,946 | Patent Expiration: | Oct 3, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION | ||||||||
| Patent: | 7,629,345 | Patent Expiration: | Jan 5, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION | ||||||||
| Patent: | 7,910,767 | Patent Expiration: | Jan 5, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION | ||||||||
Expired US Patents for NDA 207795
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb | VYZULTA | latanoprostene bunod | SOLUTION/DROPS;OPHTHALMIC | 207795-001 | Nov 2, 2017 | 6,211,233 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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