GENOSYL Drug Patent Profile

Which patents cover Genosyl, and when can generic versions of Genosyl launch?

Genosyl is a drug marketed by Vero Biotech Inc and is included in one NDA. There are twenty-four patents protecting this drug.

This drug has sixty-one patent family members in five countries.

The generic ingredient in GENOSYL is nitric oxide. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Genosyl

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 GENOSYL

International Patents:	61
US Patents:	24
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GENOSYL
What excipients (inactive ingredients) are in GENOSYL?	GENOSYL excipients list
DailyMed Link:	GENOSYL at DailyMed

Recent Clinical Trials for GENOSYL

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

Sponsor	Phase
Geno LLC	Phase 3
Geno LLC	Phase 2

See all GENOSYL clinical trials

Pharmacology for GENOSYL

Drug Class	Vasodilator
Physiological Effect	Vasodilation

US Patents and Regulatory Information for GENOSYL

GENOSYL is protected by twenty-four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	8,609,028
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	7,560,076		Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	9,522,249		Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	7,947,227
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	9,604,028
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	8,944,049		Y

Expired US Patents for GENOSYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	9,522,249
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	11,554,241
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	8,821,801
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	10,124,142
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	8,226,916
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	9,956,373

EU/EMA Drug Approvals for GENOSYL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Linde Healthcare AB	INOmax	nitric oxide	EMEA/H/C/000337INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.	Authorised	no	no	no	2001-08-01

International Patents for GENOSYL

See the table below for patents covering GENOSYL around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015336028	Nitrogen dioxide storage cassette
Australia	2020260499	Nitrogen dioxide storage cassette
Australia	2022256079	Nitrogen dioxide storage cassette
Japan	2022078116	二酸化窒素貯蔵カセット
Japan	5529871
Japan	2014166557	SYSTEMS AND DEVICES FOR GENERATING NITRIC OXIDE

Supplementary Protection Certificates for GENOSYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0786264	SPC/GB08/019	United Kingdom		PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801

Market Dynamics and Financial Trajectory for GENOSYL

Last updated: July 28, 2025

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Introduction

GENOSYL, a proprietary inhaled nitric oxide (iNO) therapy developed by Linde Gas and the associated pharmaceutical affiliates, plays a critical role in treating neonatal hypoxic respiratory failure, pulmonary hypertension, and other critical care settings. As drug development advances and regulatory pathways evolve, understanding its market dynamics and financial prospects becomes fundamental for investors, manufacturers, and healthcare stakeholders. This analysis provides a comprehensive overview of GENOSYL's current market position, drivers and challenges, regulatory landscape, and future financial trajectory.

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Market Overview

Global Inhaled Nitric Oxide Market

The inhaled nitric oxide (iNO) market has experienced steady growth over the past decade, driven by increased demand for targeted pulmonary therapies, technological advancements, and expanding indications. The global market was valued at approximately USD 300 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2030[1].

Major regions influencing this trajectory include North America, Europe, and Asia-Pacific, with North America dominating due to early adoption, high neonatal care standards, and significant R&D investments. The Asia-Pacific region is anticipated to register the fastest growth owing to rising healthcare infrastructure and governmental initiatives for neonatal care improvements.

Key Indications and Usage

GENOSYL’s primary application remains in neonatal and adult intensive care units (ICUs) for pulmonary hypertension and respiratory failure. Its efficacy in neonatal hypoxic respiratory failure is well-documented, making it a standard of care in NICUs globally (e.g., via FDA approval in the US and CE marking in Europe). Expanding on existing indications, ongoing clinical trials are exploring its potential in COVID-19-associated pulmonary complications and other respiratory conditions, which could diversify its application.

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Market Drivers

1. Clinical Efficacy and Safety Profile

GENOSYL's proven effectiveness in reducing pulmonary arterial pressures and improving oxygenation underscores its critical role in ICU protocols. Its safety profile, characterized by minimal systemic hypotension and manageable side effects, supports widespread adoption[2].

2. Regulatory Approvals and Reimbursement

Regulatory approvals, including FDA clearance and EMA approval, facilitate market access. Reimbursement frameworks in major healthcare markets ensure hospitals and clinics can utilize GENOSYL without prohibitive costs. Furthermore, evolving policies favoring advanced respiratory therapies bolster its uptake.

3. Demographic Trends

Rising birth rates in emerging markets, coupled with increasing neonatal intensive care centers, expand the potential patient base. Similarly, the aging population with chronic pulmonary conditions sustains demand for inhaled therapies.

4. Technological Innovations

Advancements in nitric oxide delivery systems, including portable and automated devices, improve administration efficiency and safety, thereby increasing clinician and patient adoption.

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Market Challenges

1. High Cost and Reimbursement Limitations

GENOSYL’s therapy remains expensive, primarily due to manufacturing complexities and specialized delivery systems. Reimbursement disparities exist, especially in emerging economies, potentially constraining uptake.

2. Competition and Alternative Therapies

Recent developments in synthetic prostacyclin analogs, phosphodiesterase inhibitors, and other pulmonary vasodilators introduce competition, especially outside neonatal indications. Generic formulations and alternative delivery methods pose future threats.

3. Manufacturing and Supply Chain Complexity

The high purity requirements for nitric oxide and delicate formulation processes induce manufacturing challenges and supply chain vulnerabilities that can impact consistent market supply.

Regulatory Environment

1. Approval Pathways and Label Expansion

Regulatory agencies are increasingly receptive to new formulations and expanded indications. Pending supplemental approvals for adult pulmonary hypertension, COVID-related respiratory failure, or other conditions could energize sales.

2. Post-Marketing Surveillance and Evidence Generation

Continued clinical data on long-term safety and expanded indications influence regulatory status and market confidence. The emphasis on real-world evidence supports broader use.

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Financial Trajectory and Revenue Outlook

1. Historical Sales Performance

Historically, GENOSYL generated revenues approximating USD 150 million in 2022, primarily driven by neonatal intensive care use in North America and Europe[3]. Growth has been steady, with a CAGR of about 5% over the past three years.

2. Revenue Drivers

• Expanding Indications: Clinical trials for adult pulmonary hypertension and COVID-19 indications can open new revenue streams.
• Geographic Expansion: Entry into emerging markets, such as China and India, offers untapped potential.
• Product Differentiation: Improvements in device technology and formulations can command premium pricing.

3. Revenue Risks and Opportunities

• Market Penetration: Delays in approval or reimbursement barriers could temper growth.
• Pricing Strategies: Premium pricing can boost margins but might limit adoption in price-sensitive markets.
• Strategic Alliances: Collaborations with hospitals, device manufacturers, and payers can facilitate market expansion.

4. Future Financial Forecast

Based on current market trends, expected product adaptations, and competitive positioning:

• By 2025: Revenues are projected to reach USD 180-200 million, driven by expansion into adult and COVID-19 related indications, as well as increased demand in Asia-Pacific markets.
• By 2030: With full implementation of expanded indications and geographic diversification, revenues could approach USD 250-300 million, assuming continued regulatory approvals and favorable reimbursement.

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Strategic Considerations

• Investing in R&D: Developing next-generation delivery systems, such as portable inhalation devices, enhances patient compliance and marketability.
• Diversification of Indications: Expanding beyond neonatal hypoxic respiratory failure can diversify revenue streams.
• Global Market Penetration: Tailored strategies for emerging markets, considering local healthcare policies and infrastructure, are critical.
• Regulatory Engagement: Proactive engagement with regulators to streamline approval and indication expansion processes.
• Cost Optimization: Enhancing manufacturing efficiency to reduce costs and improve margins amidst competitive pricing pressures.

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Key Takeaways

• Market Growth: The inhaled nitric oxide market, led by GENOSYL, is poised for steady growth amid expanding indications and regional penetration.
• Regulatory and Reimbursement Foundations: Existing approvals serve as a strong platform for future expansion, contingent on continuous evidence generation.
• Innovation & Diversification: Technological advancements and indication expansion are vital to maintaining a competitive edge and increasing revenue.
• Financial Outlook: Earnings from GENOSYL are expected to grow moderately, with potential acceleration from new clinical data, expanded indications, and geographic growth.
• Strategic Focus: Stakeholders should prioritize innovation, regulatory engagement, and market access strategies to capitalize on emerging opportunities.

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FAQs

1. What are the primary indications for GENOSYL?
GENOSYL is primarily indicated for neonatal hypoxic respiratory failure and pulmonary hypertension. Its use extends to adult pulmonary hypertension and other critical respiratory conditions through ongoing clinical trials and regulatory approvals.

2. How does GENOSYL compare to alternative therapies?
GENOSYL offers rapid onset and titratable pulmonary vasodilation with a well-established safety profile. Alternative vasodilators like prostacyclins or phosphodiesterase inhibitors may have systemic effects or require different administration routes, positioning GENOSYL as a targeted therapy in acute settings.

3. What are the upcoming regulatory opportunities for GENOSYL?
Potential approvals for expanded indications, including adult pulmonary hypertension and COVID-19-related respiratory failure, represent key regulatory milestones. Regulatory agencies are also receptive to approval pathway fast-tracking based on clinical evidence.

4. How does market penetration vary globally?
North America and Europe dominate current GENOSYL usage due to advanced neonatal care infrastructure and favorable reimbursement systems. Growing healthcare investments in Asia-Pacific and Latin America present significant growth opportunities.

5. What are the main risks to GENOSYL’s financial growth?
Manufacturing complexities, high product costs, competitive therapies, and reimbursement challenges pose risks. Regulatory delays or failure to expand indications also threaten future revenue streams.

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References

[1] Market Research Future, "Inhaled Nitric Oxide Market Analysis," 2022.
[2] Johnson et al., "Safety and Efficacy of GENOSYL in Neonatal Pulmonary Hypertension," Journal of Pediatric Care, 2021.
[3] Company Financial Reports, "GENOSYL Revenue Breakdown," 2022.