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GENOSYL Drug Patent Profile

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

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 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

Indicators of Generic Entry

Summary for GENOSYL

International Patents:	60
US Patents:	24
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	2
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

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	6,758,214

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/000337 INOmax, 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
Japan	2012502770
European Patent Office	2247381	CONVERSION DE DIOXYDE D'AZOTE (NO2) EN MONOXYDE D'AZOTE (NO) (CONVERSION OF NITROGEN DIOXIDE (NO2) TO NITRIC OXIDE (NO))
Japan	5554723
European Patent Office	2328592	SYSTÈMES ET DISPOSITIFS PERMETTANT LA GÉNÉRATION D'OXYDE NITRIQUE (SYSTEMS AND DEVICES FOR GENERATING NITRIC OXIDE)

Supplementary Protection Certificates for GENOSYL

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

GENOSYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GENOSYL

Introduction to GENOSYL

GENOSYL, developed by VERO Biotech, is a revolutionary tankless inhaled nitric oxide (iNO) delivery system that has transformed the treatment of respiratory and cardiovascular conditions, particularly in neonatal and acute care settings. Here’s a detailed look at the market dynamics and financial trajectory of GENOSYL.

Market Drivers

The demand for GENOSYL is driven by several key factors:

Growing Prevalence of Respiratory Diseases

The increasing incidence and prevalence of respiratory diseases such as pulmonary hypertension, neonatal hypoxic respiratory failure, and chronic obstructive pulmonary disease (COPD) are significant drivers for the inhaled nitric oxide market. GENOSYL's ability to improve oxygenation and reduce pulmonary pressures makes it a vital tool in managing these conditions[1][3][4].

Outbreak of Respiratory Infections

The outbreak of respiratory infections like COVID-19 has further accelerated the demand for inhaled nitric oxide delivery systems. The U.S. FDA's emergency use authorization for GENOSYL in critical COVID-19 patients suffering from respiratory failure has been a crucial factor[1].

Geriatric Population and Chronic Diseases

The rise in the geriatric population and the increasing prevalence of chronic diseases in regions like Europe and Asia-Pacific also contribute to the growing demand for GENOSYL[1][4].

Market Growth and Projections

Global Market Size

The global inhaled nitric oxide market, which includes GENOSYL, is expected to grow significantly. By 2033, the market is projected to reach approximately USD 1.9 billion from USD 0.9 billion in 2023, growing at a CAGR of 7.5% during the forecast period[4].

Regional Dominance

North America currently leads the market with the highest revenue share, primarily due to the recognition of GENOSYL's therapeutic benefits and the expansion of healthcare facilities equipped to administer this therapy. However, the Asia-Pacific region is expected to experience the highest CAGR during the forecast period, driven by rising healthcare investments and an increasing prevalence of respiratory disorders[4].

Product Innovation and FDA Approvals

Tankless Delivery System

GENOSYL's innovative tankless design eliminates the reliance on bulky and labor-intensive nitric oxide tanks, making it a more convenient and cost-effective alternative. This innovation has been a game-changer in neonatal intensive care units and acute care settings[2][5].

FDA Approvals

The FDA approval of GENOSYL, particularly the third-generation design, has been a significant milestone. This approval marks the first innovation in the delivery of inhaled nitric oxide in 20 years, underscoring VERO Biotech's commitment to innovation and patient care[5].

Financial Trajectory

Funding and Investments

VERO Biotech has secured substantial funding to support the commercialization and development of GENOSYL. In February 2024, the company received a $65 million credit facility from Horizon Technology Finance and Monroe Capital. This funding is aimed at refinancing existing loans and accelerating the commercial expansion of GENOSYL[2].

Previous Funding Rounds

In January 2023, VERO Biotech raised $30 million from Petrichor, a healthcare-dedicated growth capital provider, to further develop and commercialize the GENOSYL Delivery System. This funding has strengthened VERO Biotech's position as a leader in neonatal intensive care[5].

Revenue and Valuation

While specific revenue figures and valuation details are not publicly disclosed, VERO Biotech is currently generating revenue and has raised close to $300 million in total funding to date. The market response to GENOSYL has been remarkable, with a focus on scaling up production and market deployment[2].

Market Challenges and Restraints

Product Recalls

Recent product recalls of inhaled nitric oxide delivery systems in Europe have posed a challenge to the market growth. However, VERO Biotech's commitment to quality and innovation has helped mitigate these risks[1].

Macroeconomic and Geopolitical Factors

Economic downturns and geopolitical instability can impact healthcare spending and supply chain disruptions, affecting the adoption of advanced treatments like GENOSYL. Despite these challenges, government initiatives to improve respiratory care and the expansion of healthcare infrastructure in emerging markets continue to drive demand[4].

Key Takeaways

• Market Growth: The global inhaled nitric oxide market, driven by GENOSYL, is expected to grow at a CAGR of 7.5% from 2023 to 2033.
• Innovation: GENOSYL's tankless design and FDA approvals have revolutionized the treatment of respiratory and cardiovascular conditions.
• Funding: Significant funding rounds, including a $65 million credit facility, support the commercial expansion and development of GENOSYL.
• Regional Dominance: North America leads the market, but the Asia-Pacific region is expected to experience the highest CAGR.
• Challenges: Product recalls and macroeconomic/geopolitical factors pose challenges, but government initiatives and healthcare infrastructure expansion drive growth.

FAQs

1. What is GENOSYL? GENOSYL is a tankless inhaled nitric oxide (iNO) delivery system developed by VERO Biotech, used primarily in neonatal and acute care settings.

2. What are the key drivers of the GENOSYL market? The key drivers include the growing prevalence of respiratory diseases, outbreaks of respiratory infections, and the rise in the geriatric population.

3. How much funding has VERO Biotech received for GENOSYL? VERO Biotech has received significant funding, including a $65 million credit facility in 2024 and a $30 million funding round in 2023.

4. What is the projected market size for inhaled nitric oxide by 2033? The global inhaled nitric oxide market is expected to reach approximately USD 1.9 billion by 2033.

5. Which region is expected to experience the highest CAGR for the inhaled nitric oxide market? The Asia-Pacific region is expected to experience the highest CAGR during the forecast period.

Citations

1. Fortune Business Insights: Inhaled Nitric Oxide (NO) Delivery Systems Market Size, Industry ...
2. Axios: Exclusive: Vero Biotech secures $65M credit facility for nitric oxide ...
3. KBV Research: Inhaled Nitric Oxide Market Size & Top Market Players, 2026
4. Market.us: Inhaled Nitric Oxide Market Growth Analysis | CAGR of 7.5%
5. VERO Biotech: VERO Biotech Raises $30 Million to Accelerate Commercialization ...