Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim

Last Updated: November 29, 2022

Details for New Drug Application (NDA): 208259

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

NDA 208259 describes ROCKLATAN, which is a drug marketed by Aerie Pharms 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 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
Applicant:Aerie Pharms Inc
Ingredient:latanoprost; netarsudil dimesylate
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208259
Generic Entry Date for 208259*:
Constraining patent/regulatory exclusivity:

*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 Action Rho 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 Aerie Pharmaceuticals, 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 Aerie Pharmaceuticals, 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
Regulatory Exclusivity Expiration:Dec 18, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Mar 12, 2022
Regulatory Exclusivity Use:NEW COMBINATION
Patent:See Plans and PricingPatent Expiration:Jan 27, 2030Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.