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Generated: November 18, 2018

DrugPatentWatch Database Preview

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 five patents protecting this drug. Additional details are available on the RHOPRESSA profile page.

The generic ingredient in RHOPRESSA is netarsudil dimesylate. One supplier is listed for this compound. Additional details are available on the netarsudil dimesylate profile page.
Summary for 208254
Tradename:RHOPRESSA
Applicant:Aerie Pharms Inc
Ingredient:netarsudil dimesylate
Patents:5
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 ActionRho Kinase Inhibitors
Suppliers and Packaging for NDA: 208254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RHOPRESSA netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208254 NDA Aerie Pharmaceuticals Inc. 70727-497 70727-497-25 1 BOTTLE in 1 CARTON (70727-497-25) > 2.5 mL in 1 BOTTLE
RHOPRESSA netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208254 NDA Aerie Pharmaceuticals 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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.02% BASE
Approval Date:Dec 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 18, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Nov 10, 2030Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Patent:➤ Sign UpPatent Expiration:Jul 11, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

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