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. Eight 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:	136
Clinical Trials:	4
Patent Applications:	3,009
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	505213
Spain	505212
Australia	6278280
Spain	8207535

ROMAZICON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ROMAZICON (Flumazenil)

Market Overview

The global flumazenil market, under which ROMAZICON falls, is characterized by a complex interplay of factors influencing its growth and challenges. Here are the key dynamics and financial projections for this market.

Market Size and Growth

The global flumazenil market is estimated to be valued at US$ 20.528 million in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.8% from 2022 to 2030, reaching a value of US$ 25.526 million by 2030[4].

Market Drivers

Clinical Guidelines and Adoption

Enhanced clinical guidelines recommending the use of flumazenil for specific benzodiazepine overdose cases and its adoption in hospital and clinical settings as a standard antidote for benzodiazepine toxicity are significant drivers. This widespread acceptance ensures a steady demand for the drug[1].

Technological Advancements

Technological advancements in drug delivery systems, optimizing the administration of flumazenil, also contribute to market growth. These innovations enhance the safety and efficacy of the drug, making it more appealing to healthcare providers[1].

Government Regulations

Government regulations and policies facilitating the approval and use of flumazenil in emergency situations further support market expansion. Clear regulatory frameworks help in the smooth distribution and use of the drug[1].

Market Restraints

Competition from Alternatives

Competition from alternative benzodiazepine antagonist medications limits flumazenil's market penetration. The presence of other effective treatments reduces the market share of flumazenil[1].

High Research and Development Costs

The high costs associated with the research and development of flumazenil deter potential market entrants. These costs can be a significant barrier to new companies looking to enter the market[1].

Market Opportunities

Expanding Research Applications

Expanding research on flumazenil's potential in reversing central nervous system depression from non-benzodiazepine drugs and its integration into protocols for substance abuse treatment and rehabilitation programs offer significant growth opportunities. These new applications can augment the market size and diversify the use of flumazenil[1].

Advancements in Formulations and Delivery Methods

Advancements in flumazenil formulations and delivery methods to enhance safety and efficacy are crucial. Innovations such as extended shelf life formulations can improve distribution, especially in resource-constrained environments[1].

Market Challenges

Regulatory Complexities

Navigating regulatory complexities and compliance demands in the flumazenil pharmaceutical industry is a significant challenge. The market heavily relies on the healthcare sector’s regulatory landscape, requiring adaptability to changing policies and emerging medical insights[1].

Supply Chain Disruptions

Addressing supply chain disruptions affecting the availability of flumazenil in the global market is another challenge. Discontinuations, such as the one introduced by the U.S. FDA in 2020, can restrict market growth[4].

Regional Analysis

The global flumazenil market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold a dominant position during the forecast period, driven by increasing anxiety disorders and the subsequent use of benzodiazepines[4].

Key Players and Strategies

Major players in the flumazenil market include Hoffmann La Roche, Akorn-Strides, LLC, Sandoz Canada Incorporated, Fresenius Kabi USA, LLC, and others. These companies are focusing on launching new products, expanding into emerging markets, and collaborating with health organizations for awareness and training programs to fortify their market position[4].

Financial Projections

• Base Year: 2021
• Market Size in 2022: US$ 20.528 million
• Forecast Period: 2022 to 2030
• CAGR: 2.8%
• 2030 Value Projection: US$ 25.526 million[4].

Clinical and Practical Considerations

Indications and Usage

Flumazenil is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases of general anesthesia, diagnostic and therapeutic procedures, and benzodiazepine overdose. It is also used in pediatric patients for the reversal of conscious sedation induced by benzodiazepines[5].

Dosage and Administration

The recommended doses of flumazenil range from 0.2 mg to 1 mg, administered intravenously at a rate of 0.2 mg/min. The onset of reversal is usually evident within 1 to 2 minutes, with 80% response reached within 3 minutes[2].

Safety and Efficacy

Flumazenil is generally well-tolerated but can precipitate withdrawal seizures in patients physically dependent on benzodiazepines. It does not reverse the effects of opioids or other central nervous system depressants not acting through the benzodiazepine receptor[5].

Key Takeaways

• The global flumazenil market is projected to grow at a CAGR of 2.8% from 2022 to 2030.
• Market growth is driven by enhanced clinical guidelines, technological advancements, and government regulations.
• Competition from alternative medications and high R&D costs are significant restraints.
• Expanding research applications and advancements in formulations offer growth opportunities.
• Regulatory complexities and supply chain disruptions are key challenges.
• North America is expected to dominate the market due to increasing anxiety disorders.

FAQs

Q: What is the primary use of flumazenil in clinical settings?

A: Flumazenil is primarily used for the complete or partial reversal of the sedative effects of benzodiazepines in cases of general anesthesia, diagnostic and therapeutic procedures, and benzodiazepine overdose[5].

Q: What are the potential risks associated with the use of flumazenil?

A: Flumazenil can precipitate withdrawal seizures in patients physically dependent on benzodiazepines and may cause resedation if the effects of the benzodiazepine outlast those of flumazenil[5].

Q: How does flumazenil work?

A: Flumazenil competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby antagonizing the sedative effects of benzodiazepines[5].

Q: What are the market drivers for the flumazenil market?

A: Market drivers include enhanced clinical guidelines, technological advancements in drug delivery systems, and favorable government regulations[1].

Q: What are the challenges faced by the flumazenil market?

A: The market faces challenges such as regulatory complexities, supply chain disruptions, and competition from alternative benzodiazepine antagonist medications[1].

Sources

1. Research and Markets: Flumazenil Market Size, Competitors & Forecast to 2030
2. Genentech: ROMAZICON - Prescribing Information
3. UCLA Electronic Theses and Dissertations: eScholarship
4. Coherent Market Insights: Flumazenil Market Size, Trends and Forecast to 2030
5. Drugs.com: Romazicon: Package Insert / Prescribing Information