RHOPRESSA Drug Patent Profile

When do Rhopressa patents expire, and what generic alternatives are available?

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

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

The generic ingredient in RHOPRESSA is netarsudil mesylate. One supplier is listed for this compound. Additional details are available on the netarsudil mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Rhopressa

Rhopressa 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 RHOPRESSA

International Patents:	68
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	9
Drug Prices:	Drug price information for RHOPRESSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RHOPRESSA
What excipients (inactive ingredients) are in RHOPRESSA?	RHOPRESSA excipients list
DailyMed Link:	RHOPRESSA at DailyMed

See drug prices for RHOPRESSA

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

NDA:

208254

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 RHOPRESSA

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

Sponsor	Phase
Alcon, a Novartis Company	PHASE4
East Coast Institute for Research	PHASE4
Florida Eye Specialists	PHASE4

See all RHOPRESSA clinical trials

Pharmacology for RHOPRESSA

Drug Class	Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Paragraph IV (Patent) Challenges for RHOPRESSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RHOPRESSA	Ophthalmic Solution	netarsudil mesylate	0.02%	208254	2	2021-12-20

US Patents and Regulatory Information for RHOPRESSA

RHOPRESSA is protected by fifteen US patents.

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	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes			Y	Y
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes			Y	Y
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes

International Patents for RHOPRESSA

When does loss-of-exclusivity occur for RHOPRESSA?

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 RHOPRESSA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009273932
Japan	2019094339	併用療法 (COMBINATORY TREATMENT)
Poland	3811943
Japan	7057317

Supplementary Protection Certificates for RHOPRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3053913	132020000000043	Italy		PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121
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	301038	Netherlands		PRODUCT NAME: NETARSUDIL, OF EEN ZOUT OF SOLVAAAT DAARVAN, IN HET BIJZONDER NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3461484	SPC/GB21/033	United Kingdom		PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RHOPRESSA

Last updated: July 27, 2025

Introduction

RHOPRESSA (Rhopressa contraindications, pharmacodynamics, and market positioning) represents a novel therapeutic agent within ophthalmology, specifically targeting glaucomatous conditions. As a once-daily prostaglandin analog, Rhopressa claims a unique position in its class. Understanding its market trajectory involves evaluating existing industry dynamics, regulatory landscapes, competitive positioning, clinical efficacy, and sales potential. This analysis explores these factors, providing insight into its commercial prospects.

Overview of Rhopressa

Rhopressa (netarsudil ophthalmic solution) was approved by the U.S. Food and Drug Administration (FDA) in December 2017 for lowering intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Its mechanism involves Rho kinase (ROCK) inhibition, which enhances aqueous humor outflow through the trabecular meshwork—a distinct pathway compared to other prostaglandins. By addressing a different outflow pathway, Rhopressa positions itself uniquely in a crowded glaucoma market.

Market Dynamics in Glaucoma Therapeutics

1. Growing Disease Burden

Glaucoma affects over 76 million globally, projected to rise to approximately 112 million by 2040 [1]. The aging population and increasing prevalence of ocular hypertension directly boost demand for IOP-lowering therapies like Rhopressa. Chronic disease management expectations favor treatments with improved safety profiles and novel mechanisms.

2. Competitive Landscape

The glaucoma market is highly competitive, dominated by prostaglandin analogs such as latanoprost, bimatoprost, and travoprost, which account for a significant share of prescriptions. These agents are well-established, with decades of clinical usage. Rhopressa faces competition not only from generics but also from novel agents, including fixed-dose combinations that improve adherence.

3. Market Adoption Factors

Despite its innovative mechanism, Rhopressa initially experienced slow uptake due to:

• Prescriber familiarity with existing therapies.
• Cost considerations, as newer agents often have higher prices.
• Formulation and delivery challenges that influence patient adherence.
• Combination therapy positioning, as Rhopressa is primarily prescribed as monotherapy or adjunct.

The drug's ability to demonstrate superior efficacy, safety, or convenience will influence its market penetration over time.

4. Regulatory and Reimbursement Environment

Insurance coverage and formulary placements significantly affect sales. Early positioning in formularies and inclusion in treatment guidelines catalyze adoption. Regulatory approvals outside the U.S. remain critical for international growth.

Financial Trajectory and Revenue Projections

1. Sales Performance Since Launch

Initial sales for Rhopressa were modest, constrained by clinician familiarity and formulary access barriers. According to IQVIA data, in its first year, sales reached approximately US$50 million globally, with the U.S. accounting for a substantial share [2].

2. Growth Drivers

Key drivers of future revenue include:

• Expansion of indications, including potential use in combination therapies.
• Combination products—notably, the FDA approval of Rocklatan (netarsudil and latanoprost) in 2019, which combines Rhopressa with a prostaglandin analog for enhanced efficacy [3].
• Increased prescriber familiarity as clinical evidence accumulates.
• Global market penetration, especially in Europe and Asia.

3. Potential Market Size and Revenue Forecasts

The global glaucoma drug market is projected to reach US$7.9 billion by 2025, growing at a CAGR of approximately 4% [4]. Rhopressa's niche, focused on patients inadequately controlled on existing therapies, limits its total addressable market; however, the impending launch of more combination therapies and expanded indications could significantly expand revenue streams.

Analysts project Rhopressa's peak sales could approach US$300-500 million annually within 5 years, contingent on:

• Market share gains.
• Competitive dynamics with generics.
• Acceptance of combination formulations.

4. Risks and Constraints

Potential setbacks include:

• Delayed adoption due to clinician inertia.
• Competitive erosion from emerging therapies.
• Pricing pressures and reimbursement hurdles.
• Market access challenges in non-U.S. regions.

Industry Trends Shaping Rhopressa’s Future

Innovation in Drug Delivery

Advances such as sustained-release implants and novel formulations could improve patient compliance and broaden market access. Rhopressa's pipeline expansion, including combination drugs like Rocklatan, aligns with this trend, integrating efficacy and ease of use.

Personalized Medicine and Clinical Evidence

Growing emphasis on personalized approaches in glaucoma management may influence prescribing patterns, favoring agents with demonstrated superior safety or efficacy profiles. Long-term data confirming Rhopressa's benefits bolster its case.

Regulatory and Market Expansion

Continued regulatory approval in Europe, Asia, and other emerging markets will diversify revenue sources. Local pricing policies and healthcare infrastructure will shape economic viability.

Conclusion and Outlook

Rhopressa exhibits promising commercial potential as a non-traditional glaucoma therapy, particularly through its role in combination treatments and expanding indications. Its market trajectory hinges on clinical validation, formulary positioning, competitive pressures, and global expansion strategies. While early sales reflect cautious adoption, ongoing pipeline developments and real-world evidence could catalyze significant growth within the next five years, aligning with the broader trend toward targeted, mechanism-based ocular pharmacology.

Key Takeaways

• Rhopressa’s unique Rho kinase inhibition mechanism offers differentiation in glaucoma treatment.
• Initial market adoption remains modest but is expected to improve through combination therapies and expanding indications.
• Peak sales projections suggest $300-500 million annually, conditioned on competitive positioning and market expansion.
• The global glaucoma market’s growth provides a favorable backdrop for future revenue enhancement.
• Strategic investments in clinical data, market access, and international approvals are vital for realizing Rhopressa’s full commercial potential.

FAQs

1. How does Rhopressa differentiate from traditional glaucoma drugs?
Rhopressa inhibits Rho kinase, enhancing aqueous humor outflow via the trabecular pathway, unlike prostaglandins that increase uveoscleral outflow. This mechanism allows for combination therapies to provide additive IOP reduction.

2. What factors influence Rhopressa’s market growth?
Market growth depends on clinical efficacy, safety profile, prescriber acceptance, regulatory approvals outside the U.S., formulary positioning, and the success of combination products like Rocklatan.

3. What are the primary challenges facing Rhopressa’s commercial success?
Key challenges include clinician familiarity with existing therapies, formulary access, pricing and reimbursement barriers, and competition from generics and innovative treatments.

4. How significant are combination therapies for Rhopressa’s future?
Highly significant. The approval and market acceptance of combination drugs like Rocklatan substantially expand Rhopressa’s revenue potential due to superior efficacy and improved patient adherence.

5. What is the long-term outlook for Rhopressa in the global glaucoma market?
Given the rising prevalence of glaucoma, the advent of effective combination therapies, and ongoing clinical research, Rhopressa’s long-term outlook remains optimistic, with prospects for sustained growth and market expansion.

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References:

[1] Tham, Y. C., et al. (2014). Global prevalence of glaucoma and projections of glaucoma burden through 2040. Ophthalmology, 121(11), 2081-2090.
[2] IQVIA. (2022). US Ophthalmic Drug Sales Data.
[3] FDA. (2019). Approval of Rocklatan for Glaucoma.
[4] MarketsandMarkets. (2021). Ophthalmic Drugs Market by Disease, Molecule, Route of Administration, and Region.