ROCKLATAN Drug Patent Profile

Which patents cover Rocklatan, and when can generic versions of Rocklatan launch?

Rocklatan is a drug marketed by Alcon Labs Inc and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-eight patent family members in fourteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Rocklatan

Rocklatan was eligible for patent challenges on December 18, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2034. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ROCKLATAN

International Patents:	68
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for ROCKLATAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROCKLATAN
What excipients (inactive ingredients) are in ROCKLATAN?	ROCKLATAN excipients list
DailyMed Link:	ROCKLATAN at DailyMed

See drug prices for ROCKLATAN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ROCKLATAN

Constraining patent/regulatory exclusivity:

9,415,043

NDA:

208259

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.

Recent Clinical Trials for ROCKLATAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Oregon Health and Science University	PHASE4
Alcon Research	PHASE4
Center for Sight Las Vegas	PHASE4

See all ROCKLATAN clinical trials

Pharmacology for ROCKLATAN

Drug Class	Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Paragraph IV (Patent) Challenges for ROCKLATAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ROCKLATAN	Ophthalmic Solution	latanoprost; netarsudil dimesylate	0.005%/0.02%	208259	2	2021-12-20

US Patents and Regulatory Information for ROCKLATAN

ROCKLATAN is protected by seventeen US patents.

This potential generic entry date is based on patent 9,415,043.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	9,993,470		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	10,532,993
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	9,096,569		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	10,654,844		Y	Y
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes	10,588,901		Y	Y

International Patents for ROCKLATAN

When does loss-of-exclusivity occur for ROCKLATAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Denmark

European Patent Office

Finland

Hungary

Japan

Poland

Portugal

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ROCKLATAN around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2731869	COMPOSES AMIDES BETA ET GAMMA-AMINO ISOQUINOLINE ET COMPOSES BENZAMIDE SUBSTITUE (BETA-AND GAMMA-AMINO-ISOQUINOLINE AMIDE COMPOUNDS AND SUBSTITUTED BENZAMIDE COMPOUNDS)
Spain	2672624
Canada	2760611	INHIBITEURS A DOUBLE ACTION ET LEURS PROCEDES D'UTILISATION (DUAL-ACTION INHIBITORS AND METHODS OF USING SAME)
Australia	2018202990	Combination therapy
Spain	2942898

Supplementary Protection Certificates for ROCKLATAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3461484	122021000036	Germany		PRODUCT NAME: LATANOPROST, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND NETARSUDIL MESYLAT; REGISTRATION NO/DATE: EU/1/20/1502 20210107
3461484	C202130024	Spain		PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREIOISOMERO, SAL O SALVADO DEL MISMO EN COMBINACION CON LATANOPROST O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1502; DATE OF AUTHORISATION: 20210107; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1502; DATE OF FIRST AUTHORISATION IN EEA: 20210107
3053913	122020000016	Germany		PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119
3053913	2020C/510	Belgium		PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
3053913	20C1017	France		PRODUCT NAME: NETARSUDIL, OU ENANTIOMERE, DIASTEREOMERE, SEL OU SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1400 20191121

Market Dynamics and Financial Trajectory for ROCKLATAN

Last updated: July 27, 2025

Introduction

ROCKLATAN (netarsudil ophthalmic solution) represents a significant advancement in the treatment of glaucoma and ocular hypertension. Approved by the U.S. Food and Drug Administration (FDA) in December 2019, ROCKLATAN is a Rho kinase (ROCK) inhibitor that enhances aqueous humor outflow, providing a novel mechanism to reduce intraocular pressure (IOP). Its market entry coincides with a growing global burden of glaucoma, an increasingly competitive landscape of IOP-lowering therapies, and shifting prescribing paradigms. This comprehensive analysis examines the market dynamics influencing ROCKLATAN's commercial trajectory and projects its potential financial performance over the coming years.

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Market Landscape for Glaucoma Therapeutics

Growing Global Burden of Glaucoma

Glaucoma remains the second leading cause of irreversible blindness worldwide, affecting approximately 76 million people as of 2020, with projections estimating over 111 million by 2040 (1). The rising prevalence, especially among aging populations in North America, Europe, and Asia, escalates demand for effective IOP-lowering therapies. This demographic shift acts as a fundamental driver supporting ROCKLATAN's market potential.

Current Treatment Modalities and Competitive Drivers

Traditional first-line treatments include prostaglandin analogs, beta-blockers, alpha-adrenergic agonists, and carbonic anhydrase inhibitors. Despite their widespread use, limitations such as inadequate IOP control, local side effects, and patient adherence issues persist (2). Recently, combination therapies and novel drug classes, including Rho kinase inhibitors, have entered the arena to address unmet needs.

ROCKLATAN's primary competitors encompass:

• Prostaglandin analogs (e.g., latanoprost, travoprost) – dominant market share
• Beta-blockers (e.g., timolol)
• Combination products (e.g., Durezol, Trusopt/Timoptic combinations)
• Emerging Rho kinase inhibitors (e.g., netarsudil, ripasudil)

The ongoing development of gene therapies and sustained-release devices could influence future market composition but currently have a limited impact.

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Market Dynamics Influencing ROCKLATAN

Innovation and Differentiation

ROCKLATAN's mechanism—Rho kinase inhibition—targets distinct pathways implicated in IOP regulation unlike prostaglandins or beta-blockers. It enhances trabecular meshwork outflow, addressing a key resistance pathway. Clinical trials, including Phase 3 results, demonstrated significant IOP reduction (~4-5 mmHg from baseline), with a favorable safety profile, including manageable conjunctival hyperemia. This differentiation supports its adoption as monotherapy or adjunctively.

Regulatory Approvals and Geographic Expansion

Post-FDA approval, ROCKLATAN received approval in several markets, including Canada, the European Union, and Japan, expanding its footprint. The regulatory trajectory influences sales volume and geographic penetration, with faster approvals in high-prevalence markets enhancing revenue potential (3).

Pricing Strategy and Reimbursement Dynamics

Pricing for ROCKLATAN generally aligns with other branded prostaglandin therapies, with premiums justified by novel mechanism and perceived efficacy. Reimbursement policies and formulary placements significantly impact patient access and prescribing patterns. Favorable insurance coverage accelerates uptake, particularly in markets with high glaucoma prevalence.

Physician Adoption and Prescribing Trends

Physician acceptance hinges on clinical efficacy, safety data, ease of use, and positioning relative to existing therapies. Education campaigns highlighting its distinct mechanism foster prescriber confidence. Early adoption gained momentum in patients inadequately controlled by existing therapies or with intolerances.

Market Barriers and Challenges

• Market penetration lag: Established therapies' dominance and prescriber inertia pose obstacles.
• Cost concerns: High drug prices could limit access, especially where reimbursement is restrictive.
• Safety awareness: Concerning side effects, such as conjunctival hyperemia, require ongoing management and patient counseling.
• Competitive Rho kinase inhibitors: Ripasudil, mainly approved in Japan, and other pipeline agents create competitive pressure.

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Financial Trajectory and Revenue Potential

Sales Performance and Growth Projections

Initial launch data indicated modest revenues, with analysts estimating approximately $60-80 million in U.S. sales in 2021. The compound annual growth rate (CAGR) projections vary but are generally optimistic, anticipating sales surpassing $200 million by 2025 as market penetration deepens (4).

Factors Supporting Revenue Expansion

• Market penetration: Growth driven by physician acceptance, increased awareness, and expanded geographic reach.
• Combination potential: Synergistic use with other IOP medications could expand labeled indications and prescription volume.
• Pipeline development: Anticipated combination formulations or new indications could diversify revenue streams.
• Reimbursement improvements: Better coverage and formulary inclusion will facilitate patient access.

Revenue Challenges and Risks

• Pricing pressures: Payers may push for concessions, impacting profit margins.
• Competitive landscape: Introduction of generic alternatives or competing Rho kinase inhibitors could erode market share.
• Regulatory hurdles: Future approvals or label modifications based on ongoing safety data could influence prescribing patterns.

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Strategic Opportunities and Future Outlook

Partnerships & Collaborations

Partnerships with global pharma and ophthalmology-focused organizations could accelerate geographic expansion and co-marketing efforts, enhancing sales growth.

Product Line Expansion

Development of fixed-dose combination therapies with other IOP agents may increase adherence and convenience, positively impacting sales.

Technological Integration

Integration with digital health tools for patient monitoring and adherence could improve outcomes and foster brand loyalty.

Market Penetration in Emerging Economies

Targeting prevalent glaucoma populations in Asia, Latin America, and Africa offers significant upside amid rising awareness and improving healthcare infrastructure.

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Key Takeaways

• Growing glaucoma prevalence and unmet needs position ROCKLATAN for sustained demand in global markets.
• Distinct mechanism of action and encouraging clinical data strengthen its competitive edge.
• Market penetration remains incremental, constrained by established therapies and reimbursement complexities.
• Revenue projections indicate steady growth, with potential to surpass $200 million annually by 2025 as adoption accelerates.
• Strategic partnerships, pipeline expansion, and market diversification are critical to maximizing financial outcomes.

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FAQs

1. How does ROCKLATAN differentiate itself from traditional glaucoma medications?
ROCKLATAN's mechanism—Rho kinase inhibition—specifically targets aqueous humor outflow resistance at the trabecular meshwork, unlike prostaglandins or beta-blockers that primarily reduce aqueous humor production or increase uveoscleral outflow.

2. What are the main barriers to ROCKLATAN's widespread adoption?
Barriers include indifference from physicians accustomed to existing therapies, high pricing, insurance reimbursement hurdles, and competition from established treatments and emerging drug candidates.

3. What is the revenue outlook for ROCKLATAN over the next five years?
Analysts project sales exceeding $200 million annually by 2025, driven by increased prescriber acceptance, geographic expansion, and pipeline developments.

4. Are there any significant safety concerns associated with ROCKLATAN?
The most common adverse event is conjunctival hyperemia, typically mild and manageable. No significant systemic safety issues have been reported, although ongoing surveillance continues.

5. How might future regulatory approvals impact ROCKLATAN’s market performance?
Additional approvals for novel indications or combination formulations could expand its use, significantly boosting sales. Conversely, regulatory restrictions or safety concerns could temper growth momentum.

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Sources

1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262–267.
2. Weinreb RN, Aung T, Parrish RK. Prevention of glaucoma: a review. JAMA. 2014;311(18):1901–1911.
3. U.S. Food and Drug Administration. ROCKLATAN (netarsudil ophthalmic solution) approval letter. 2019.
4. MarketWatch. glaucoma drugs market forecast 2023–2030.

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