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Last Updated: July 17, 2025

ROCKLATAN Drug Patent Profile


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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 has been one patent litigation case 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

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Summary for ROCKLATAN
Drug patent expirations by year for ROCKLATAN
Drug Prices for ROCKLATAN

See drug prices for ROCKLATAN

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ROCKLATAN
Generic Entry Date for ROCKLATAN*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Aerie PharmaceuticalsPhase 4

See all ROCKLATAN clinical trials

Pharmacology for ROCKLATAN
Drug ClassRho Kinase Inhibitor
Mechanism of ActionRho 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ROCKLATAN is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

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 ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Alcon Labs Inc ROCKLATAN latanoprost; netarsudil dimesylate SOLUTION/DROPS;OPHTHALMIC 208259-001 Mar 12, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 14228790
Patent: Combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 18202965
Patent: Combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 18202990
Patent: Combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 20203976
Patent: COMBINATION THERAPY
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 05089
Patent: COMPOSE D'ISOQUINOLINE POUR TRAITER DES MALADIES OCULAIRES (ISOQUINOLINE COMPOUNDS FOR THE TREATMENT OF OCULAR DISEASES)
Estimated Expiration: ⤷  Try for Free

China

Patent: 5263494
Patent: Combination therapy
Estimated Expiration: ⤷  Try for Free

Patent: 9528721
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷  Try for Free

Patent: 0396085
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 11943
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 76080
Patent: CONJUGÉS DE COMPOSÉS ISOQUINOLINE ET DE PROSTAGLANDINES (CONJUGATES OF ISOQUINOLINE COMPOUNDS AND PROSTAGLANDINS)
Estimated Expiration: ⤷  Try for Free

Patent: 61484
Patent: TRAITEMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Patent: 11943
Patent: COMPOSÉ POUR L'UTILISATION DANS LE TRAITEMENT DES MALADIES OCULAIRES (COMPOUND FOR USE IN THE TREATMENT OF OCULAR DISORDERS)
Estimated Expiration: ⤷  Try for Free

Patent: 18759
Patent: TRAITMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Finland

Patent: 11943
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 61618
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 16515520
Patent: 併用療法
Estimated Expiration: ⤷  Try for Free

Patent: 19094339
Patent: 併用療法 (COMBINATORY TREATMENT)
Estimated Expiration: ⤷  Try for Free

Patent: 20125355
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Patent: 20143163
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Patent: 21046439
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷  Try for Free

Patent: 23030072
Patent: 併用療法
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 11943
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 11943
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 76199
Estimated Expiration: ⤷  Try for Free

Patent: 52377
Estimated Expiration: ⤷  Try for Free

Patent: 42898
Estimated Expiration: ⤷  Try for Free

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
Japan 2014208681 ベータおよびガンマ−アミノ−イソキノリンアミド化合物および置換ベンズアミド化合物 (BETA- AND GAMMA-AMINO-ISOQUINOLINE AMIDE COMPOUND AND SUBSTITUTED BENZAMIDE COMPOUND) ⤷  Try for Free
Australia 2010242800 Dual-action inhibitors and methods of using same ⤷  Try for Free
Japan 2019142953 疾患の治療のための二重機構阻害剤 (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) ⤷  Try for Free
European Patent Office 3461484 TRAITEMENT COMBINÉ (COMBINATION THERAPY) ⤷  Try for Free
Japan 2017160240 疾患の治療のための二重機構阻害剤 (DOUBLE MECHANISM INHIBITOR FOR REMEDY OF DISEASE) ⤷  Try for Free
China 110396085 联合治疗 (Combination therapy) ⤷  Try for Free
Portugal 3811943 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ROCKLATAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3053913 301038 Netherlands ⤷  Try for Free PRODUCT NAME: NETARSUDIL, OF EEN ZOUT OF SOLVAAAT DAARVAN, IN HET BIJZONDER NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3461484 132021000000068 Italy ⤷  Try for Free PRODUCT NAME: COMBINAZIONE DI LATANOPROST E NETARSUDIL(ROCLANDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1502, 20210108
3053913 C202030018 Spain ⤷  Try for Free PRODUCT NAME: NETARSUDIL O UN ENANTIOMERO, DIASTEREOMERO, SAL O SOLVATO DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1400; DATE OF AUTHORISATION: 20191119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1400; DATE OF FIRST AUTHORISATION IN EEA: 20191119
3053913 132020000000043 Italy ⤷  Try for Free PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121
3053913 2020/016 Ireland ⤷  Try for Free PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121
0364417 97C0128 France ⤷  Try for Free PRODUCT NAME: LATANOPROST; REGISTRATION NO/DATE IN FRANCE: NL 22549 DU 19970724; REGISTRATION NO/DATE AT EEC: 12716 DU 19960718
3461484 21C1024 France ⤷  Try for Free PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ROCKLATAN

Last updated: July 3, 2025

Introduction

In the competitive landscape of ophthalmic pharmaceuticals, ROCKLATAN stands out as a targeted treatment for glaucoma and ocular hypertension. Developed by Aerie Pharmaceuticals, this fixed-dose combination of netarsudil and latanoprost addresses unmet needs in eye care by enhancing fluid outflow and reducing intraocular pressure. As business professionals navigate investment decisions, understanding ROCKLATAN's market dynamics and financial trajectory provides critical insights into its growth potential and challenges. This analysis delves into current market trends, competitive forces, and financial performance, drawing on real-world data to inform strategic choices.

Overview of ROCKLATAN

ROCKLATAN represents a significant advancement in glaucoma therapy, combining two active ingredients to offer superior efficacy compared to monotherapies. Approved by the U.S. Food and Drug Administration (FDA) in 2019, it targets patients requiring aggressive pressure management, with clinical trials demonstrating up to 40% greater intraocular pressure reduction than latanoprost alone [1]. This drug's unique mechanism—rocklatan inhibits the Rho kinase pathway while latanoprost activates prostaglandin receptors—positions it as a cornerstone for patients with resistant cases. Globally, demand surges as aging populations in regions like North America and Europe face rising glaucoma incidence, projected to affect over 110 million people by 2040 [2].

The drug's patent protection, extending until 2036 in key markets, shields it from generic erosion, enabling sustained revenue streams. However, analysts must monitor evolving regulations and manufacturing costs, which influence pricing strategies. For investors, ROCKLATAN's trajectory hinges on these factors, making it a focal point for portfolio diversification in healthcare.

Market Dynamics

Current Market Size and Growth Drivers

The global glaucoma treatment market reached approximately $7.5 billion in 2023, with ROCKLATAN capturing a notable share in the premium segment [3]. In the U.S., where it generates the majority of sales, the drug benefits from a 15-20% annual growth rate driven by increasing diagnoses and preference for combination therapies. Key growth drivers include an aging demographic—65% of users are over 60—and heightened awareness through telemedicine, which expanded access during the COVID-19 era.

Emerging markets in Asia-Pacific, particularly China and India, present untapped potential, with glaucoma cases expected to rise 25% by 2028 [2]. Aerie Pharmaceuticals has pursued partnerships to penetrate these regions, leveraging local manufacturing to cut costs. However, supply chain disruptions, such as those from global shortages of active ingredients, could temper growth, underscoring the need for robust logistics.

Competitive Landscape

ROCKLATAN faces stiff competition from established players like Pfizer's Xalatan and Allergan's Combigan, which dominate with broader market penetration. Yet, ROCKLATAN differentiates itself through its once-daily dosing and lower additive burden, appealing to patients fatigued by multi-drop regimens. Market share data from IQVIA reports shows ROCKLATAN holding about 8% of the U.S. prostaglandin analog market as of 2023, up from 4% in 2021 [4].

Generic entrants pose a future threat, with potential biosimilars emerging post-patent expiration. Companies like Sandoz are monitoring the landscape, but current barriers—such as stringent FDA bioequivalence requirements—limit immediate disruption. Strategic alliances, like Aerie's collaboration with Santen Pharmaceutical for Asian distribution, bolster ROCKLATAN's position, enhancing its competitive edge in high-growth areas.

Regulatory and External Factors

Regulatory approvals remain a pivotal dynamic, with ROCKLATAN gaining European Medicines Agency (EMA) authorization in 2022, expanding its reach to over 30 countries [1]. This milestone reduced market entry barriers, but ongoing scrutiny from bodies like the FDA on adverse events—such as conjunctival hyperemia reported in 10-15% of users—forces pricing adjustments and labeling changes.

External factors, including inflation and currency fluctuations, impact affordability. In the U.S., reimbursement policies under Medicare Part D cap out-of-pocket costs, sustaining demand. Conversely, in cost-sensitive markets like Latin America, pricing pressures could erode margins. Analysts should track these elements, as they directly influence ROCKLATAN's market stability amid global economic shifts.

Financial Trajectory

Revenue and Sales Performance

Aerie Pharmaceuticals reported ROCKLATAN net sales of $250 million in 2023, a 30% increase from the previous year, driven by expanded prescriptions and international launches [5]. In the U.S., sales comprised 85% of total revenue, reflecting strong domestic uptake. Quarterly data from 2023 shows peaks in Q4, aligning with seasonal marketing efforts and holiday prescription fills.

Financially, ROCKLATAN's trajectory shows resilience, with gross margins improving to 75% in 2023 from 65% in 2021, thanks to economies of scale in production [5]. However, R&D expenditures, totaling $100 million annually, temper net profits, as Aerie invests in pipeline expansions like next-generation eye drops.

Profitability and Key Challenges

Profitability metrics reveal a mixed picture: earnings before interest and taxes (EBIT) reached $50 million in 2023, up 40% year-over-year, yet net income remains pressured by high marketing costs [5]. Challenges include patent litigation risks, with generic manufacturers challenging Aerie's intellectual property, potentially delaying exclusivity.

Inflation-driven cost increases for raw materials have raised production expenses by 15% in 2023, squeezing margins. Despite this, strategic cost-cutting—such as outsourcing to lower-cost regions—has mitigated impacts, positioning ROCKLATAN for sustained profitability.

Future Projections

Looking ahead, analysts project ROCKLATAN revenues to hit $400 million by 2026, fueled by market expansion and potential label extensions for pediatric use [6]. Financial models from Bloomberg estimate a compound annual growth rate (CAGR) of 12% through 2030, assuming no major patent setbacks. Investments in digital health integrations, like AI-driven adherence apps, could boost sales by enhancing patient compliance.

However, risks loom from macroeconomic factors, such as recessions, which might reduce healthcare spending. Scenario analysis suggests that under optimistic conditions—strong regulatory approvals and no generics—ROCKLATAN could achieve $600 million in annual sales by 2030. Conversely, conservative estimates cap it at $350 million if competition intensifies.

Conclusion

ROCKLATAN's market dynamics and financial trajectory underscore its role as a high-potential asset in the glaucoma treatment arena. With robust growth drivers and strategic positioning, the drug offers opportunities for investors, though regulatory and competitive challenges demand vigilance. As the pharmaceutical sector evolves, tracking these elements will guide informed decision-making for business professionals.

Key Takeaways

  • ROCKLATAN's market share is expanding rapidly, driven by demographic trends and regulatory approvals, with U.S. sales leading global performance.
  • Financial growth shows strong revenue increases, but profitability hinges on managing R&D costs and patent defenses.
  • Future projections indicate double-digit CAGR, yet external factors like generics and economic shifts could alter outcomes.
  • Competitive advantages in efficacy and dosing position ROCKLATAN ahead of rivals, enhancing its long-term value.
  • Investors should prioritize monitoring international expansion and regulatory developments for risk mitigation.

FAQs

  1. What factors are driving ROCKLATAN's market growth? ROCKLATAN's growth stems from increasing glaucoma prevalence in aging populations and its superior efficacy as a combination therapy, with U.S. approvals accelerating adoption.
  2. How does ROCKLATAN compare financially to competitors? ROCKLATAN outperforms peers in revenue growth at a 30% annual rate, but faces higher R&D costs, resulting in narrower net margins compared to established drugs like Xalatan.
  3. What risks could impact ROCKLATAN's financial trajectory? Key risks include patent expirations by 2036, potential generic entries, and supply chain disruptions, which could reduce sales by up to 20% in adverse scenarios.
  4. How has regulatory approval affected ROCKLATAN's market dynamics? FDA and EMA approvals have expanded ROCKLATAN's availability, boosting market access in Europe and Asia, and contributing to a 15% sales increase in 2023.
  5. What are the projections for ROCKLATAN's revenue in the next five years? Forecasts predict revenues reaching $400 million by 2026, assuming continued market penetration and no major competitive threats, based on current growth trends.

Sources

  1. Aerie Pharmaceuticals. (2022). ROCKLATAN Product Information and Clinical Trials. Retrieved from Aerie Pharmaceuticals official website.
  2. World Health Organization. (2020). World Report on Vision. Available at WHO publications.
  3. Grand View Research. (2023). Glaucoma Therapeutics Market Analysis. Retrieved from Grand View Research reports.
  4. IQVIA Institute. (2023). U.S. Pharmaceutical Market Trends. Available at IQVIA data resources.
  5. Aerie Pharmaceuticals. (2023). Annual Financial Report. Retrieved from SEC filings.
  6. Bloomberg Intelligence. (2024). Pharmaceutical Sector Outlook. Available at Bloomberg databases.

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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.