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 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

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:	6
Patent Applications:	108
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
Massachusetts Eye and Ear Infirmary	Phase 1/Phase 2
Wills Eye	Phase 2/Phase 3
Salus University	Phase 4

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

Netherlands

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
China	110396085	联合治疗 (Combination therapy)
European Patent Office	4335507	POLYTHÉRAPIE (COMBINATION THERAPY)
Japan	2012525442
Netherlands	301101

Supplementary Protection Certificates for RHOPRESSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3053913	122020000016	Germany		PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119
3053913	2020/016	Ireland		PRODUCT NAME: NETARSUDIL, OR AN ENANTIOMER, DIASTEREOMER, SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/19/1400 20191121
3053913	2020C/510	Belgium		PRODUCT NAME: RHOKIINSA - NETARSUDIL; AUTHORISATION NUMBER AND DATE: EU/1/19/1400 20191121
3053913	C202030018	Spain		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

Market Dynamics and Financial Trajectory for Rhopressa

Introduction to Rhopressa

Rhopressa, also known as netarsudil ophthalmic solution, is a groundbreaking medication developed by Aerie Pharmaceuticals for the treatment of ocular hypertension and open-angle glaucoma. It works by improving fluid outflow through the trabecular meshwork and reducing episcleral venous pressure, offering a novel approach to managing these conditions.

Market Size and Growth

The ocular hypertension market, within which Rhopressa operates, is experiencing significant growth. As of 2023, the ocular hypertension market size was valued at USD 3,054.0 million, and it is projected to reach USD 4,538.6 million by 2034, growing at a CAGR of 3.67% during the period of 2024-2034[1].

Key Drivers of Market Growth

Several factors are driving the growth of the ocular hypertension market and, by extension, the demand for Rhopressa:

• Increasing Incidences of Eye Conditions: The growing incidences of scarring, inflammation, or structural abnormalities in the eye that impair the proper outflow of aqueous humor are significant drivers[1].
• Novel Drug Delivery Systems: The development of sustained-release implants and micro-dosing technologies is improving patient compliance and therapeutic outcomes, contributing to market growth[1].
• Advancements in Diagnostic Technologies: Enhanced imaging techniques such as optical coherence tomography (OCT) enable early and accurate detection of ocular hypertension, facilitating timely intervention and better management[1].

Rhopressa's Market Position

Rhopressa has established a strong market presence, particularly in the United States. Here are some key points highlighting its market position:

• Market Access: Rhopressa has market access for 89% of lives covered under Medicare Part D plans and commercial coverage for 90% of lives[3].
• Global Expansion: Aerie Pharmaceuticals has collaborated with Santen Pharmaceutical Co., Ltd. to expand the global deployment of Rhopressa, including territories in Europe, China, and several other regions. Rhopressa is marketed as Rhokiinsa in the EU and UK[4].

Financial Performance

The financial performance of Rhopressa is closely tied to Aerie Pharmaceuticals' overall financial health:

• Revenue Growth: In the third quarter of 2020, Rhopressa and its combination product Rocklatan generated net revenues of $20.1 million, a 9% increase from the third quarter of 2019. For the nine months ended September 30, 2020, net revenues totaled $58.5 million, reflecting a 29% increase from the same period in 2019[3].
• Recent Financial Results: As of the third quarter of 2022, Aerie's total glaucoma franchise net product revenues, which include Rhopressa and Rocklatan, were $36.1 million, up 23% compared to the same period in 2021. The company reported a net loss of $26.8 million, an improvement of 32% compared to the previous year[5].

Product Sales and Distribution

• Sales Volume: Shipments to wholesalers totaled 261,000 bottles during the third quarter of 2020, over 12% higher than the second quarter of 2020[3].
• Pricing: The average revenue per bottle was relatively consistent at $77 per bottle in the third quarter of 2020[3].

Clinical Trials and Regulatory Approvals

• Phase 3 Clinical Trials: A Phase 3 clinical trial for Rhopressa began in Japan in November 2020, marking a significant step in its global expansion[4].
• Regulatory Approvals: Rhopressa has received market authorization in the EU and UK as Rhokiinsa, and it is approved and being sold in the United States by Aerie Pharmaceuticals[4].

Collaborations and Partnerships

• Santen Pharmaceutical Co., Ltd.: Aerie has a strategic collaboration with Santen to accelerate the global deployment of Rhopressa and Rocklatan, targeting additional territories including Europe, China, and several other regions[4].

Competitive Landscape

The ocular hypertension market is competitive, but Rhopressa's unique mechanism of action and its combination product, Rocklatan, set it apart. Rocklatan combines netarsudil with latanoprost, a widely-prescribed prostaglandin analog, offering a comprehensive treatment option for patients[4].

Challenges and Opportunities

• Patient Adherence: One of the major challenges in the ocular hypertension market is patient adherence. Sustained-release drug delivery systems, such as those being developed by Aerie, are addressing this issue[1].
• Global Expansion: The collaboration with Santen and other partnerships provide significant opportunities for Rhopressa's global expansion, particularly in regions like Europe, China, and Japan[4].

Expert Insights

Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer of Aerie Pharmaceuticals, highlighted the potential of their glaucoma franchise, including Rhopressa, stating that "the value of our glaucoma franchise was further demonstrated by the recently announced collaboration with Santen Pharmaceuticals Co., Ltd. in Japan and several other countries in Asia"[3].

Illustrative Statistics

• Market Access: Rhopressa has market access for 89% of lives covered under Medicare Part D plans and commercial coverage for 90% of lives[3].
• Revenue Growth: For the nine months ended September 30, 2020, net revenues totaled $58.5 million, reflecting a 29% increase from the same period in 2019[3].
• Clinical Trials: The Phase 3 clinical trial for Rhopressa in Japan began in November 2020, marking a significant step in its global expansion[4].

Key Takeaways

• Market Growth: The ocular hypertension market is expected to grow significantly, driven by increasing incidences of eye conditions and advancements in diagnostic and treatment technologies.
• Rhopressa's Position: Rhopressa has a strong market position with significant market access and a growing global presence.
• Financial Performance: Aerie Pharmaceuticals has seen revenue growth from Rhopressa and its combination product Rocklatan, with ongoing improvements in financial performance.
• Global Expansion: Collaborations with companies like Santen are crucial for Rhopressa's global deployment.

FAQs

Q: What is Rhopressa used for? A: Rhopressa is used for the treatment of ocular hypertension and open-angle glaucoma by improving fluid outflow through the trabecular meshwork and reducing episcleral venous pressure.

Q: Who is the primary manufacturer of Rhopressa? A: Rhopressa is manufactured by Aerie Pharmaceuticals.

Q: What is the current market size of the ocular hypertension market? A: As of 2023, the ocular hypertension market size was valued at USD 3,054.0 million[1].

Q: What are the key drivers of the ocular hypertension market growth? A: The market growth is driven by increasing incidences of eye conditions, novel drug delivery systems, and advancements in diagnostic technologies[1].

Q: What are the main challenges in the ocular hypertension market? A: One of the major challenges is patient adherence, which is being addressed by sustained-release drug delivery systems[1].

Cited Sources

1. Biospace: "Ocular Hypertension Market Size to Reach USD 4,538.6 Million by 2034, Impelled by Increasing Surgical Interventions"[1].
2. Santen Pharmaceutical Co., Ltd.: "Q2 FY2023 Financial Results"[2].
3. Businesswire: "Aerie Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Business Update"[3].
4. Santen Pharmaceutical Co., Ltd.: "Santen and Aerie to accelerate global deployment of Rhopressa and Rocklatan"[4].
5. Businesswire: "Aerie Pharmaceuticals Reports Third Quarter 2022 Financial Results"[5].