Details for New Drug Application (NDA): 208254
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NDA 208254 describes RHOPRESSA, which is a drug marketed by Aerie Pharms Inc 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 RHOPRESSA profile page.
The generic ingredient in RHOPRESSA is netarsudil mesylate. 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. One supplier is listed for this compound. Additional details are available on the netarsudil mesylate profile page.
Summary for 208254
| Tradename: | RHOPRESSA |
| Applicant: | Aerie Pharms Inc |
| Ingredient: | netarsudil mesylate |
| Patents: | 13 |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 | |||||
| Regulatory Exclusivity Expiration: | Dec 18, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jan 27, 2030 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jul 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCTION OF ELEVATED INTRAOCULAR PRESSURE | ||||||||
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