Details for New Drug Application (NDA): 208254
✉ Email this page to a colleague
NDA 208254 describes RHOPRESSA, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the RHOPRESSA profile page.
The generic ingredient in RHOPRESSA is netarsudil mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the netarsudil mesylate profile page.
The generic ingredient in RHOPRESSA is netarsudil mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the netarsudil mesylate profile page.
Summary for 208254
| Tradename: | RHOPRESSA |
| Applicant: | Alcon Labs Inc |
| Ingredient: | netarsudil mesylate |
| Patents: | 15 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208254
Generic Entry Date for 208254*:
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.
Pharmacology for NDA: 208254
| Mechanism of Action | Rho Kinase Inhibitors |
Suppliers and Packaging for NDA: 208254
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254 | NDA | Alcon Laboratories, Inc. | 70727-497 | 70727-497-25 | 1 BOTTLE in 1 CARTON (70727-497-25) / 2.5 mL in 1 BOTTLE |
| RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254 | NDA | Alcon Laboratories, Inc. | 70727-497 | 70727-497-99 | 1 BOTTLE in 1 CARTON (70727-497-99) / 2.5 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.02% BASE | ||||
| Approval Date: | Dec 18, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 27, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 14, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE | ||||||||
Expired US Patents for NDA 208254
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | ⤷ Start Trial | ⤷ Start Trial |
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | ⤷ Start Trial | ⤷ Start Trial |
| Alcon Labs Inc | RHOPRESSA | netarsudil mesylate | SOLUTION/DROPS;OPHTHALMIC | 208254-001 | Dec 18, 2017 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
