NETARSUDIL MESYLATE - Generic Drug Details

What are the generic sources for netarsudil mesylate and what is the scope of freedom to operate?

Netarsudil mesylate is the generic ingredient in one branded drug marketed by Alcon Labs Inc and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Netarsudil mesylate has sixty-eight patent family members in fourteen countries.

One supplier is listed for this compound.

Summary for NETARSUDIL MESYLATE

International Patents:	68
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Patent Applications:	39
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NETARSUDIL MESYLATE
DailyMed Link:	NETARSUDIL MESYLATE at DailyMed

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

Constraining patent/regulatory exclusivity:

9,415,043

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 NETARSUDIL MESYLATE

Drug Class	Rho Kinase Inhibitor
Mechanism of Action	Rho Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NETARSUDIL MESYLATE

S01EX	Other antiglaucoma preparations
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for NETARSUDIL MESYLATE

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 NETARSUDIL MESYLATE

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	11,185,538		Y
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes	9,415,043			Y
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes	10,882,840

International Patents for NETARSUDIL MESYLATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1258617
European Patent Office	2424842	INHIBITEURS À MÉCANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE)
Australia	2017248440

Supplementary Protection Certificates for NETARSUDIL MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3053913	SPC/GB20/019	United Kingdom		PRODUCT NAME: NETARSUDIL; REGISTERED: UK EU/1/19/1400(NI) 20191121; UK PLGB 16058/003 20191121
3053913	132020000000043	Italy		PRODUCT NAME: NETARSUDIL(RHOKIINSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1400, 20191121

NETARSUDIL MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Netarsudil Mesylate

Introduction to Netarsudil Mesylate

Netarsudil mesylate is an ophthalmic solution developed for the reduction of intraocular pressure (IOP) in conditions such as open-angle glaucoma, ocular hypertension, and Fuchs' endothelial dystrophy. It is a Rho kinase inhibitor that increases the outflow of aqueous humor through the trabecular meshwork, allowing for once-daily dosing[4].

Market Outlook for Ocular Hypertension and Glaucoma

The ocular hypertension market, which includes treatments like netarsudil mesylate, is expected to grow significantly. As of 2023, the market size was valued at USD 3,054.0 million and is projected to reach USD 4,538.6 million by 2034, with a Compound Annual Growth Rate (CAGR) of 3.67% during 2024-2034. This growth is driven by increasing incidences of eye conditions and the development of novel drug delivery systems[3].

Clinical Development and Approval

Netarsudil mesylate has been approved in several regions, including the US, Sweden, the European Union, and parts of Asia. Clinical development is ongoing in Canada and Japan for open-angle glaucoma and ocular hypertension. The drug's approval was supported by data from phase III studies such as ROCKET 1 and ROCKET 2, as well as the Mercury 1 registrational study[4].

Financial Performance of Key Players

Santen Pharmaceutical's Involvement

While Santen Pharmaceutical is not the primary developer of netarsudil mesylate, the company's financial performance in the ophthalmic sector provides insights into the broader market dynamics. Santen Pharmaceutical has seen strong growth in its ophthalmic products, including a 10.5% year-over-year (YoY) revenue increase in Q1 FY2023, driven by overseas growth and market recovery in China. The company's core operating profit (Core OP) increased by 46.6% YoY, reflecting strong sales and cost optimization efforts[1].

Alcon and Aerie Pharmaceuticals

Netarsudil mesylate is developed by Alcon, which acquired Aerie Pharmaceuticals in November 2022. This acquisition has likely bolstered Alcon's portfolio in the ophthalmic segment. The financial trajectory of Alcon, post-acquisition, would include the integration of Aerie's products and research pipeline, potentially enhancing Alcon's market position and financial performance in the ocular hypertension and glaucoma treatment market.

Revenue and Profitability

The revenue generated by netarsudil mesylate is part of the broader ocular hypertension market. Given its approval and ongoing clinical development, the drug is expected to contribute significantly to the revenue of its manufacturers.

• Santen Pharmaceutical's Context: Although not directly related to netarsudil mesylate, Santen's financial results indicate a strong market for ophthalmic products. For FY2023, Santen achieved its highest revenue and core operating profit, with a revenue increase of 8.2% YoY and a core OP increase of 41.9% YoY[2].

• Market Projections: The growing demand for effective treatments in ocular hypertension and glaucoma suggests that netarsudil mesylate will be a significant contributor to the revenue of its manufacturers. The market's expected growth to USD 4,538.6 million by 2034 underscores the potential financial trajectory of this drug.

Cost and Pricing Dynamics

The cost and pricing of netarsudil mesylate are influenced by several factors, including production costs, market competition, and regulatory approvals.

• Production Costs: The cost of goods sold (COGS) for ophthalmic products can vary based on region and product mix. For instance, Santen Pharmaceutical saw a decrease in COGS ratio by 1.9 points YoY due to region/product mix and one-time factors[1].

• Pricing Strategies: The pricing of netarsudil mesylate would need to balance profitability with market competitiveness. Given its once-daily dosing convenience and long duration of effect, the drug may command a premium price, contributing to higher revenue and profitability.

Regional Market Performance

The performance of netarsudil mesylate varies across different regions:

• Asia and China: These regions have shown significant growth, with China experiencing an 81.3% YoY increase in revenue for ophthalmic products, driven by market recovery from COVID-19[1].

• EMEA: The Europe, Middle East, and Africa region has also seen strong growth, with a 36.3% YoY increase in revenue for ophthalmic products, partly due to the performance of key products like Ikervis[1].

• Americas: The region has seen structural reforms and cost optimizations, which have contributed to improved profitability despite some challenges[2].

Research and Development

The ongoing research and development in the ocular hypertension and glaucoma treatment market are crucial for the long-term success of netarsudil mesylate.

• Clinical Trials: The drug is undergoing clinical development in various regions, including Canada and Japan, which will further establish its efficacy and safety profile[4].

• Innovative Delivery Systems: The development of novel drug delivery systems, such as sustained-release implants and micro-dosing technologies, is expected to enhance patient compliance and therapeutic outcomes, driving market growth[3].

Competitive Landscape

The competitive landscape for ocular hypertension and glaucoma treatments is dynamic, with several players vying for market share.

• Key Players: Companies like Alcon, Santen Pharmaceutical, and others are actively involved in developing and marketing ophthalmic products. The acquisition of Aerie Pharmaceuticals by Alcon has strengthened Alcon's position in this market[4].

• Market Differentiation: Netarsudil mesylate's unique mechanism of action as a Rho kinase inhibitor and its once-daily dosing schedule differentiate it from other treatments, potentially giving it a competitive edge.

Regulatory Environment

The regulatory environment plays a critical role in the approval and commercialization of netarsudil mesylate.

• Approvals: The drug has received approvals in several regions, including the US, EU, and parts of Asia. Ongoing clinical trials will seek additional approvals in other regions[4].

• Compliance: Manufacturers must comply with regulatory requirements, which can impact production costs and timelines.

Key Takeaways

• Growing Market: The ocular hypertension market is expected to grow significantly, driven by increasing incidences of eye conditions and innovative drug delivery systems.
• Strong Financial Performance: Netarsudil mesylate is part of a market segment that has shown strong revenue and profitability growth.
• Regional Variations: Market performance varies across regions, with Asia and China showing significant growth.
• Ongoing R&D: Continuous clinical development and innovation in drug delivery systems are crucial for long-term success.
• Competitive Edge: Netarsudil mesylate's unique mechanism and dosing schedule provide a competitive advantage.

Frequently Asked Questions (FAQs)

1. What is netarsudil mesylate used for? Netarsudil mesylate is used for the reduction of intraocular pressure in conditions such as open-angle glaucoma, ocular hypertension, and Fuchs' endothelial dystrophy.

2. Who developed netarsudil mesylate? Netarsudil mesylate was developed by Aerie Pharmaceuticals, which was acquired by Alcon in November 2022.

3. What is the expected market size for ocular hypertension treatments by 2034? The ocular hypertension market is expected to reach USD 4,538.6 million by 2034.

4. How does netarsudil mesylate work? Netarsudil mesylate works by increasing the outflow of aqueous humor through the trabecular meshwork, thereby reducing intraocular pressure.

5. In which regions is netarsudil mesylate approved? Netarsudil mesylate is approved in the US, Sweden, the European Union, and parts of Asia, with ongoing clinical development in Canada and Japan.

Cited Sources

1. Santen Pharmaceutical Co., Ltd. - Q1 FY2023 Financial Results[1].
2. Santen Pharmaceutical Co., Ltd. - FY2023 Financial Results[2].
3. BioSpace - Ocular Hypertension Market Size to Reach USD 4,538.6 Million by 2034[3].
4. AdisInsight - Springer - Netarsudil mesylate[4].