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
Prisma Health-Midlands	Early Phase 1
Sameh Hanna, MD	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
South Korea	840000992
Spain	8207535
Monaco	1355

Market Dynamics and Financial Trajectory for ROMAZICON (Flumazenil)

Last updated: March 17, 2026

What is the current market position of ROMAZICON?

ROMAZICON (generic: Flumazenil) is a benzodiazepine antagonist primarily used to reverse sedation caused by benzodiazepine overdose. Its global sales have been stable but limited by competition and shifting clinical practices. The drug's patent expired in the late 2000s, leading to increased generic formulations.

Key market data:

Parameter	Data Point	Source Year
Global sales (2019)	Approx. $25 million	[1]
Largest markets	United States, Europe	[1]
Number of prescriptions (US, 2020)	200,000+	[2]

How has market demand evolved?

Demand driven by benzodiazepine overdose treatment, especially in emergency medicine and anesthesia reversal. Rising prescription rates for benzodiazepines in certain regions, and increased awareness of overdose management, influence the market. However, the market faces constraints:

• Generic competition: Many manufacturers produce flumazenil, reducing prices and profit margins.
• Alternative treatments: Development of newer reversal agents or tailored protocols means decreased reliance on flumazenil in some settings.
• Regulatory changes: Some countries require specific approval pathways, impacting market access.

What are the key market segments?

1. Hospital-based clinics: Main revenue source, especially emergency rooms and anesthesia departments.
2. Pre-hospital emergency services: Usage varies; some regions prefer alternative protocols.
3. Research and development: Limited owing to the drug’s established clinical profile.

Which factors influence financial performance?

• Pricing pressures: Widely available generics pushed prices downward.
• Patent status: Patent expiration has led to proliferation of generic versions, narrowing margins.
• Insurance coverage: Reimbursement policies vary; US reimbursements tend to favor generic use.
• Regulatory environment: Approvals are necessary for new formulations or indications.

What are the emerging trends and opportunities?

• Formulation innovation: Development of ready-to-use or improved stability formulations could command premium pricing.
• Expanded indications: Potential new uses, such as in managing overdose of other sedatives.
• Market penetration: Non-US markets such as Asia-Pacific have growth potential, driven by increasing medical infrastructure and benzodiazepine prescription rates.

What are the projected financial trajectories?

Forecast period	Estimated global sales	Assumptions	Source Year
2023	$20 million	Stable prescription rates, generic competition persists	[1]
2025	$22 million	Incremental market growth, slight price recovery possible	[3]
2030	$25 million	Market maturity with steady revenue; no significant innovation	Industry estimates

Growth consensus projects a compound annual growth rate (CAGR) of approximately 2–3% over the next five years, primarily driven by non-US markets and potential formulation improvements.

Risks and challenges

• Market saturation: Generic availability limits pricing power.
• Regulatory hurdles: Changes in approval and reimbursement procedures could impact sales.
• Emerging therapies: New antidotes or reversal agents could replace flumazenil.
• Market shifts: Increasing awareness and control of benzodiazepine use may reduce overdose cases.

Key takeaways

• ROMAZICON remains a niche drug with stable but limited revenue streams.
• Price competition from generics is a primary constraint.
• Growth depends on geographic expansion, formulation innovation, and potential new indications.
• Industry forecasts suggest modest long-term stability with slight growth.

FAQs

1. Is ROMAZICON patent protected?
No. The original patent expired in the late 2000s, resulting in widespread generic availability.

2. What are the primary competitors?
Generic flumazenil formulations by multiple manufacturers; no branded competitors currently dominate.

3. Are there new formulations in development?
Some companies explore stable, ready-to-use formulations, but none have received recent approval.

4. What regions offer growth opportunities?
Asia-Pacific and Latin America show potential due to expanding healthcare infrastructure and increasing benzodiazepine prescriptions.

5. Could new antidotes replace ROMAZICON?
Possible if alternative agents demonstrate superior efficacy, safety, or cost-effectiveness.

References

[1] MarketWatch. (2019). Global Flumazenil Sales Data.
[2] IQVIA. (2020). US Prescription Data for Benzodiazepine Reversal Agents.
[3] Industry Reports. (2022). Pharmacoeconomic Outlook for Sedative Reversal Agents.