ROMAZICON Drug Patent Profile

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

Romazicon is a drug marketed by Hoffmann La Roche and is included in one NDA.

The generic ingredient in ROMAZICON is flumazenil. There are four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the flumazenil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Romazicon

A generic version of ROMAZICON was approved as flumazenil by BAXTER HLTHCARE CORP on October 12^th, 2004.

Summary for ROMAZICON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	4
Patent Applications:	3,382
DailyMed Link:	ROMAZICON at DailyMed

Recent Clinical Trials for ROMAZICON

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

Sponsor	Phase
Sameh Hanna, MD	Early Phase 1
Prisma Health-Midlands	Early Phase 1
University of California, Davis	Phase 4

See all ROMAZICON clinical trials

US Patents and Regulatory Information for ROMAZICON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991		DISCN	Yes	No
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-002	Dec 20, 1991		DISCN	Yes	No

Expired US Patents for ROMAZICON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991	4,316,839

International Patents for ROMAZICON

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

Country	Patent Number	Title	Estimated Expiration
Spain	8207535
Spain	8207534
South Korea	840000991
Spain	8201163
Japan	S5659776	IMIDAZODIAZEPINE DERIVATIVE
Spain	505216
South Korea	840000993

Market Dynamics and Financial Trajectory for ROMAZICON (Flumazenil)

Last updated: July 29, 2025

Introduction

ROMAZICON (generic: Flumazenil) is a benzodiazepine antagonist primarily used to reverse the effects of benzodiazepine overdose and sedation. Since its approval by the U.S. Food and Drug Administration (FDA) in 1997, it has become an essential drug in emergency and anesthesia settings. This analysis explores the evolving market landscape, key drivers, competitive environment, and financial outlook for ROMAZICON over the coming years, providing stakeholders with comprehensive insights for strategic decision-making.

Market Overview and Key Drivers

Medical and Clinical Demand

ROMAZICON’s core utilization lies in emergency medicine and anesthesiology. Benzodiazepines are widely prescribed for anxiety, insomnia, seizures, and procedural sedation. Despite their therapeutic benefits, misuse and accidental overdose pose risks, necessitating effective reversal agents like flumazenil. The increasing incidence of benzodiazepine-related overdoses, particularly amidst the rising prescription rates and behavioral health issues, fuels demand for ROMAZICON [1].

Regulatory Status and Approvals

While approved broadly in major markets including the U.S., Europe, and Japan, regulatory frameworks influence the drug's market access and uptake. Recent updates from the FDA include revisiting labeling to highlight potential risks, such as precipitating seizures in certain patients, which could impact prescribing practices.

Healthcare Infrastructure and Adoption

Hospitals, emergency departments, and anesthesia clinics represent primary outlets. The adoption rate correlates with the prevalence of benzodiazepine use and overdose incidents, alongside hospital protocols favoring rapid reversal agents. Increased training and awareness regarding overdose management bolster the utilization of ROMAZICON.

Competitive Landscape

The market for reversal agents includes alternative therapies, but ROMAZICON remains the benchmark due to its specificity. However, competition from generic formulations and potential future antagonists influence market share dynamics. Patent expirations and generic entry generally lead to price reductions, impacting revenue potential.

Market Dynamics

Emerging Trends and Influences

• Rising Overdose Mortality: The opioid crisis, often intertwined with benzodiazepine misuse, has intensified focus on overdose management. Although ROMAZICON targets benzodiazepines specifically, the broader overdose management segment benefits from increased awareness.

• Regulatory Caution: Advisory updates emphasizing seizure risks in specific populations lead to cautious prescribing, possibly moderating demand growth.

• Genetic and Personalized Medicine: Emerging research into genetic factors influencing benzodiazepine metabolism may refine patient selection and dosing, indirectly affecting ROMAZICON's utilization patterns.

• Market Access and Reimbursement: Cost-effectiveness analyses favor ROMAZICON due to its efficacy, but reimbursement policies vary across regions, influencing hospital procurement decisions.

Competitive Risks and Opportunities

The advent of novel reversal agents, potentially with improved safety profiles or broader indications, poses competitive threats. Conversely, expanding indications and formulations (e.g., intranasal or auto-injectors) represent growth opportunities, especially in pre-hospital emergency settings.

Financial Trajectory and Revenue Forecast

Historical Sales Performance

Although precise global sales data for ROMAZICON remains proprietary, estimates suggest modest but steady growth, driven by increasing overdose rates and hospital adoption. In 2021, global sales were approximated at USD 250 million, with North America accounting for the majority share due to high incidence rates and healthcare infrastructure.

Projected Market Growth

Analysts forecast a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by:

• Increasing overdose incidents globally, especially in North America and Europe.
• Expanded use in pre-hospital emergency services.
• Greater awareness and protocols standardizing overdose response.

Pricing and Market Penetration

The entry of generic formulations post-patent expiry leads to price erosion, but volume-driven sales sustain revenues. Market penetration deepens as hospitals incorporate ROMAZICON into standardized overdose management protocols, especially with supportive regulatory and insurance coverage.

Potential Disruptors

Emerging compounds or alternative dosing strategies could impact revenue if clinical trials show superior safety or efficacy. Additionally, reimbursement shifts or safety concerns related to seizure risks could influence sales trajectories.

Conclusion and Strategic Implications

ROMAZICON’s market remains inherently linked to trends in overdose epidemiology, hospital protocols, and regulatory climates. While growth prospects are moderate, strategic expansion into pre-hospital settings, formulation innovations, and targeted education campaigns could amplify revenue streams. Stakeholders should monitor regulatory updates, emerging competitors, and evolving treatment guidelines to optimize market positioning.

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Key Takeaways

• Increasing Demand: Driven by the rising prevalence of benzodiazepine overdoses and expanded hospital protocols.
• Regulatory Impact: Label updates and safety concerns influence prescribing and adoption patterns.
• Market Competition: Generic entries and potential new antagonists shape pricing and market share.
• Growth Opportunities: Formulation diversification and expanding indications in pre-hospital emergencies.
• Financial Outlook: Moderate growth forecasted, with elasticity impacted by safety profiles, approval expansions, and healthcare policies.

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FAQs

1. How does regulatory safety information influence ROMAZICON sales?
Label updates highlighting seizure risks can lead to more cautious usage, potentially slowing demand growth. However, heightened awareness may also promote appropriate utilization in emergency settings, balancing effects.

2. What are the main competitive threats to ROMAZICON?
Generic formulations offering lower prices pose an immediate threat. Future novel reversal agents with improved safety profiles could also capture market share if supported by clinical superiority.

3. How significant is the market opportunity in pre-hospital emergency services?
Greater integration of ROMAZICON in pre-hospital protocols, including paramedic emergency kits, presents comparable or higher revenue potential compared to hospital settings, especially as overdoses increasingly require rapid intervention.

4. What impact will emerging overdose trends have on the drug’s financial trajectory?
An increase in benzodiazepine overdose cases generally supports stable or growing demand. Conversely, shifts toward alternative therapies or changes in prescribing practices could moderate growth.

5. How will patent expirations influence ROMAZICON’s future revenue?
Patent expiry typically leads to generic competition, lowering prices but potentially increasing volume sales. Strategic marketing and expanding indications can offset revenue declines from price erosion.

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References

[1] CDC. (2020). Benzodiazepine overdose and trends. Centers for Disease Control and Prevention.