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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 208259


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NDA 208259 describes ROCKLATAN, which is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug. Additional details are available on the ROCKLATAN profile page.

The generic ingredient in ROCKLATAN is latanoprost; netarsudil dimesylate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the latanoprost; netarsudil dimesylate profile page.
Summary for 208259
Tradename:ROCKLATAN
Applicant:Alcon Labs Inc
Ingredient:latanoprost; netarsudil dimesylate
Patents:17
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208259
Generic Entry Date for 208259*:
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: 208259
Mechanism of ActionRho Kinase Inhibitors
Suppliers and Packaging for NDA: 208259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259 NDA Alcon Laboratories, Inc. 70727-529 70727-529-25 1 BOTTLE, PLASTIC in 1 CARTON (70727-529-25) / 2.5 mL in 1 BOTTLE, PLASTIC
ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259 NDA Alcon Laboratories, Inc. 70727-529 70727-529-99 1 BOTTLE, PLASTIC in 1 CARTON (70727-529-99) / 2.5 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.005%;EQ 0.02% BASE
Approval Date:Mar 12, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 27, 2030Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Patent:⤷  Sign UpPatent Expiration:Jul 11, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Patent:⤷  Sign UpPatent Expiration:Mar 14, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

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