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Last Updated: December 23, 2024

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RHOPRESSA Drug Patent Profile


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When do Rhopressa patents expire, and when can generic versions of Rhopressa launch?

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

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Drug patent expirations by year for RHOPRESSA
Drug Prices for RHOPRESSA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RHOPRESSA
Generic Entry Date for RHOPRESSA*:
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 RHOPRESSA

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

SponsorPhase
Massachusetts Eye and Ear InfirmaryPhase 1/Phase 2
Wills EyePhase 2/Phase 3
Salus UniversityPhase 4

See all RHOPRESSA clinical trials

Pharmacology for RHOPRESSA
Drug ClassRho Kinase Inhibitor
Mechanism of ActionRho 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RHOPRESSA is ⤷  Subscribe.

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 RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes 8,450,344 ⤷  Subscribe Y Y ⤷  Subscribe
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes 9,931,336 ⤷  Subscribe Y Y ⤷  Subscribe
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes 10,882,840 ⤷  Subscribe ⤷  Subscribe
Alcon Labs Inc RHOPRESSA netarsudil mesylate SOLUTION/DROPS;OPHTHALMIC 208254-001 Dec 18, 2017 RX Yes Yes 11,021,456 ⤷  Subscribe ⤷  Subscribe
>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 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

Patent: 14228790
Patent: Combination therapy
Estimated Expiration: ⤷  Subscribe

Patent: 18202965
Patent: Combination therapy
Estimated Expiration: ⤷  Subscribe

Patent: 18202990
Patent: Combination therapy
Estimated Expiration: ⤷  Subscribe

Patent: 20203976
Patent: COMBINATION THERAPY
Estimated Expiration: ⤷  Subscribe

Canada

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

China

Patent: 5263494
Patent: Combination therapy
Estimated Expiration: ⤷  Subscribe

Patent: 9528721
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷  Subscribe

Patent: 0396085
Patent: 联合治疗 (Combination therapy)
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 11943
Estimated Expiration: ⤷  Subscribe

European Patent Office

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

Patent: 61484
Patent: TRAITEMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷  Subscribe

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

Patent: 18759
Patent: TRAITMENT COMBINÉ (COMBINATION THERAPY)
Estimated Expiration: ⤷  Subscribe

Finland

Patent: 11943
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 61618
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 16515520
Patent: 併用療法
Estimated Expiration: ⤷  Subscribe

Patent: 19094339
Patent: 併用療法 (COMBINATORY TREATMENT)
Estimated Expiration: ⤷  Subscribe

Patent: 20125355
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷  Subscribe

Patent: 20143163
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷  Subscribe

Patent: 21046439
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷  Subscribe

Patent: 23030072
Patent: 併用療法
Estimated Expiration: ⤷  Subscribe

Netherlands

Patent: 1101
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 11943
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 11943
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 76199
Estimated Expiration: ⤷  Subscribe

Patent: 52377
Estimated Expiration: ⤷  Subscribe

Patent: 42898
Estimated Expiration: ⤷  Subscribe

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
Finland 3811943 ⤷  Subscribe
Poland 3811943 ⤷  Subscribe
Australia 2021204320 ⤷  Subscribe
Canada 2929545 INHIBITEURS A MECANISME DOUBLE POUR LE TRAITEMENT DE MALADIE (DUAL MECHANISM INHIBITORS FOR THE TREATMENT OF DISEASE) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RHOPRESSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3053913 C202030018 Spain ⤷  Subscribe 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
3461484 21C1024 France ⤷  Subscribe PRODUCT NAME: ASSOCIATION DE NETARSUDIL OU L'UN DE SES SELS ET DE LATANOPROST; REGISTRATION NO/DATE: EU/1/20/1502 20210108
3053913 SPC/GB20/019 United Kingdom ⤷  Subscribe PRODUCT NAME: NETARSUDIL; REGISTERED: UK EU/1/19/1400(NI) 20191121; UK PLGB 16058/003 20191121
3053913 122020000016 Germany ⤷  Subscribe PRODUCT NAME: NETARSUDIL, ODER EIN ENANTIOMER, DIASTEREOMER, SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1400 20191119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

RHOPRESSA Market Analysis and Financial Projection Experimental

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].

More… ↓

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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.