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

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

International Patents for ROMAZICON

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

Country	Patent Number	Title	Estimated Expiration
Greece	70772
New Zealand	195071	IMIDAZO(1,4)DIAZEPINES
South Korea	830004299
Monaco	1355

ROMAZICON Market Analysis and Financial Projection

Last updated: February 17, 2026

What is the current status of ROMAZICON in the pharmaceutical market?

ROMAZICON, with the generic name flumazenil, is marketed primarily as an antidote for benzodiazepine overdose. It is approved in multiple jurisdictions, including the U.S., Europe, and Asia, with indications limited to reversal of sedative effects caused by benzodiazepine medications during anesthesia or in overdose cases. Its patent expiration varies globally: in the U.S., the patent expired in 2001, allowing generic manufacturers to enter the market.

How does ROMAZICON's patent and regulatory landscape influence its investment potential?

ROMAZICON's core patent protections have expired, classifying it as a generic drug. Generics typically face high competitive pressure, leading to reduced profit margins. However, high switching rates from benzodiazepines to other sedatives, coupled with emergency department demand, sustain sales. Regulatory approval remains straightforward due to its established safety profile, but the limited patent life constrains opportunities for exclusive pricing or new branding.

What are the key revenue drivers for ROMAZICON?

• Market Approvals: Widely approved in key markets, including the U.S., EU, and Asia.
• Usage Volume: Frequently used in hospitals for emergencies involving benzodiazepine overdose.
• Price and Margin: Low-cost generic status results in slim margins; volume drives revenue.
• Competitors: Several manufacturers produce generic flumazenil, intensifying price competition.

What factors impact the supply chain and manufacturing?

Manufacturing is relatively straightforward due to the molecule’s simplicity. Suppliers of active pharmaceutical ingredients (APIs) and excipients are abundant. Disruptions are rare but can influence supply levels and pricing.

How do emerging treatments and market shifts affect ROMAZICON's prospects?

Developments in alternative reversal agents are minimal; no significant new therapies are projected to displace ROMAZICON in the near term. However, evolving sedative management practices and shifts toward non-benzodiazepine sedatives for anxiety or sleep may marginally decrease emergency treatment volume. The increasing use of non-benzodiazepine sedatives reduces the incidence of overdose requiring reversal.

What are the financial metrics relevant to investment?

• Market Size: Estimated global sales of $80-100 million per year (e.g., IQVIA data, 2022).
• Profit Margins: Typical gross margins for generic injectables around 40-50%, but net margins are often below 10% due to competition.
• Price Trends: Slight decline over the past decade with increased generic competition.
• Market Share: Dominated by a few large producers—Teva, Mylan (now part of Viatris), and generic injectables firms.

What are the regulatory and legal risks?

• Patent Challenges: No active patents, reducing litigation risk.
• Regulatory Scrutiny: Any change in drug safety profile or manufacturing standards can impact approval status.
• Liability Risks: As an emergency drug, liabilities are low, but adverse event reports can influence usage trends.

What is the outlook for R&D and pipeline development?

ROMAZICON has limited scope for significant R&D investments given its established profile. Developing new indications or formulations faces regulatory and commercial barriers due to its current role. Any innovation would likely focus on improved formulations for stability or administration convenience.

Key Investment Considerations

• Market Dynamics: Expanding or contracting based on benzodiazepine overdose prevalence and alternative treatments.
• Competitive Landscape: Dominated by several generic producers, with price competition eroding margins.
• Regulatory Risks: Low, assuming established manufacturing and approval statuses.
• Revenue Stability: Tied to hospital emergency protocols and usage rates, which tend to be stable but may decline with shifting drug use patterns.

Key Takeaways

ROMAZICON, as a generic antidote for benzodiazepine overdose, has stable but limited growth prospects. Market revenue is driven by hospital demand, but a saturated generic market constrains profitability. No significant new product development or regulatory hurdles are expected to alter its market position substantially. Investment opportunities are primarily in companies with established generic manufacturing capabilities and stable supply chains.

FAQs

1. Can ROMAZICON's sales grow significantly?
Unlikely. Sales are tied to demand for emergency reversal of benzodiazepine overdose, a stable but mature market.

2. Are there anticipated patent protections or exclusivity periods?
No; the patent has expired, and generic competition dominates the market.

3. What are the major competitive threats?
Price wars from generic manufacturers and shifts in sedation practices reducing overdose incidents.

4. Is there potential for new formulations or delivery methods?
Limited; current formulations meet emergency needs, and innovation is unlikely to command premium pricing.

5. How does regulatory risk affect investments?
Low if manufacturing standards remain compliant; adverse safety reports could influence market perception but are unlikely to eliminate demand.

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Citations
[1] IQVIA, 2022 Global Market Data on Anti-Overdose Drugs.
[2] U.S. FDA Approved Drugs Database, 2022.
[3] European Medicines Agency (EMA), 2022. Market Authorization Data for Flumazenil.