FLUMAZENIL - Generic Drug Details

What are the generic sources for flumazenil and what is the scope of patent protection?

Flumazenil is the generic ingredient in two branded drugs marketed by Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Rising, Sagent Pharms, Sandoz, and Hoffmann La Roche, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for flumazenil. Eight suppliers are listed for this compound.

Summary for FLUMAZENIL

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	49
Patent Applications:	4,676
Drug Prices:	Drug price trends for FLUMAZENIL
What excipients (inactive ingredients) are in FLUMAZENIL?	FLUMAZENIL excipients list
DailyMed Link:	FLUMAZENIL at DailyMed

See drug prices for FLUMAZENIL

Recent Clinical Trials for FLUMAZENIL

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

Sponsor	Phase
Pusan National University Yangsan Hospital	N/A
Yonsei University	N/A
Daegu Catholic University Medical Center	N/A

See all FLUMAZENIL clinical trials

Pharmacology for FLUMAZENIL

Drug Class

Benzodiazepine Antagonist

Medical Subject Heading (MeSH) Categories for FLUMAZENIL

Antidotes

GABA Modulators

Anatomical Therapeutic Chemical (ATC) Classes for FLUMAZENIL

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for FLUMAZENIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076955-001	Oct 12, 2004	AP	RX	No	No
Rising	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	078595-001	May 13, 2008	AP	RX	No	No
Hoffmann La Roche	ROMAZICON	flumazenil	INJECTABLE;INJECTION	020073-001	Dec 20, 1991		DISCN	Yes	No
Rising	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	078595-002	May 13, 2008		DISCN	No	No
Baxter Hlthcare Corp	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076755-001	Oct 12, 2004	AP	RX	No	No

Expired US Patents for FLUMAZENIL

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

FLUMAZENIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flumazenil

Market Size and Growth Projections

The global flumazenil market is anticipated to experience steady growth over the forecast period of 2022-2030. As of 2021, the market was estimated to be around USD 18.5 million, and it is projected to reach approximately USD 23.7 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of nearly 2.8%[1][4].

Driving Factors

Increasing Anxiety Disorders

The rise in anxiety disorders among the population is a significant driver for the flumazenil market. Benzodiazepines, which are commonly used to treat anxiety, can cause sedative effects that need to be reversed, making flumazenil a crucial medication. The United States, in particular, has a high rate of anxiety disorders, with up to 33.7% of people expected to experience an anxiety disorder at some point in their lives[1].

Clinical Uses

Flumazenil is primarily used for the reversal of sedative effects of benzodiazepines in conscious sedation and general anesthesia, as well as for managing benzodiazepine overdose. Its effectiveness in these clinical scenarios contributes to its market growth[3].

Market Segmentation

By Application

The market is segmented based on application, with the anti-sedation segment expected to lead during the forecast period. This includes reversing sedation from benzodiazepines used in various anxiety disorders such as panic disorder, generalized anxiety disorder, social anxiety disorder, and specific phobias[1].

By Distribution Channel

Hospital pharmacies are anticipated to dominate the distribution channel segment. These pharmacies offer convenience and the ability to prescribe medication intake, making them a preferred choice for patients[1].

Regional Dynamics

North America

North America is expected to remain one of the most appealing markets throughout the forecast period, driven by a rise in anxiety disorders among the population. Data from the Centers for Disease Control and Prevention (CDC) indicates an increase in symptoms of anxiety or depressive disorders among adults, further supporting the growth in this region[1].

Challenges and Constraints

COVID-19 Pandemic Impact

The COVID-19 pandemic had a negative impact on the global flumazenil market, affecting the drug supply chain and leading to a scarcity of medications at the retail level. This disruption in production and delivery reduced the availability of flumazenil[1].

Market Withdrawal

The potential withdrawal of flumazenil from the market is another constraint that could impact its growth. This could be due to various factors, including regulatory issues or market competition[1].

Financial Performance and Projections

Revenue and Market Share

The global flumazenil market is valued at USD 20.528 million in 2022 and is expected to grow steadily over the forecast period. The revenue growth is largely driven by the increasing demand for flumazenil in clinical settings, particularly in hospital pharmacies[4].

Cost and Pricing

The cost of flumazenil can vary based on the distribution channel and geographical location. Hospital pharmacies, being the dominant distribution channel, play a significant role in pricing strategies. The convenience and accessibility offered by hospital pharmacies can influence the pricing dynamics of the drug[1].

Pharmacokinetics and Clinical Implications

Mechanism of Action

Flumazenil acts as a competitive antagonist to benzodiazepines, reversing their sedative effects. Its pharmacokinetics involve rapid onset and extensive distribution, with a peak effect observed within 6 to 10 minutes after administration[3].

Adverse Effects and Contraindications

While flumazenil is effective, it can precipitate seizures and withdrawal in patients using benzodiazepines for medical disorders. It is contraindicated in patients with a history of seizures, head injury, or those who have ingested tricyclic antidepressants. These factors must be considered in the financial and market analysis to ensure safe and effective use[3].

Key Takeaways

• The global flumazenil market is projected to grow at a CAGR of 2.8% from 2022 to 2030.
• Increasing anxiety disorders and the need for benzodiazepine reversal are key drivers of market growth.
• Hospital pharmacies dominate the distribution channel segment.
• North America is expected to remain a significant market due to high rates of anxiety disorders.
• The COVID-19 pandemic and potential market withdrawal are challenges that could impact growth.

FAQs

Q: What is the primary use of flumazenil in clinical settings? A: Flumazenil is primarily used for the reversal of sedative effects of benzodiazepines in conscious sedation and general anesthesia, as well as for managing benzodiazepine overdose[3].

Q: Which region is expected to dominate the flumazenil market during the forecast period? A: North America is anticipated to remain one of the most appealing markets throughout the forecast period due to a rise in anxiety disorders among the population[1].

Q: What are the potential adverse effects of flumazenil? A: Flumazenil can precipitate seizures and withdrawal in patients using benzodiazepines for medical disorders. It is also contraindicated in patients with a history of seizures, head injury, or those who have ingested tricyclic antidepressants[3].

Q: How has the COVID-19 pandemic impacted the flumazenil market? A: The COVID-19 pandemic had a negative impact on the global flumazenil market, affecting the drug supply chain and leading to a scarcity of medications at the retail level[1].

Q: What is the estimated market size of the flumazenil market in 2022? A: The market is estimated to be valued at around USD 20.528 million in 2022[4].

Cited Sources:

1. The Brainy Insights: Flumazenil Market Size, Share, Trends, Global Forecast – 2030
2. Biospace: Eagle Pharmaceuticals Provides Business Update and Reiterates 2023 Guidance
3. NCBI Bookshelf: Flumazenil - StatPearls
4. Coherent Market Insights: Flumazenil Market Size, Trends and Forecast to 2030