FLAGYL ER Drug Patent Profile

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

Flagyl Er is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FLAGYL ER is metronidazole. There are eighteen drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flagyl Er

A generic version of FLAGYL ER was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for FLAGYL ER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	74
Patent Applications:	3,959
DailyMed Link:	FLAGYL ER at DailyMed

Recent Clinical Trials for FLAGYL ER

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

Sponsor	Phase
Leiden University Medical Center	Phase 4
University of North Carolina, Chapel Hill	Phase 2
University of Amsterdam	Phase 2

See all FLAGYL ER clinical trials

US Patents and Regulatory Information for FLAGYL ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997		DISCN	Yes	No

Expired US Patents for FLAGYL ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997

International Patents for FLAGYL ER

See the table below for patents covering FLAGYL ER around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2181985	COMPOSITIONS DE METRONIDAZOLE A LIBERATION MODIFIEE ET LEURS PROCEDES DE FABRICATION ET D'UTILISATION (MODIFIED-RELEASE METRONIDAZOLE COMPOSITIONS AND METHODS FOR MAKING AND USING SAME)
China	1095665
Mexico	9602951	COMPOSICIONES DE METRONIDAZOL DE LIBERACION MODIFICADA Y METODOS PARA FABRICAR Y UTILIZAR LAS MISMAS. (MODIFIED-RELEASE METRONIDAZOLE COMPOSITIONS AND METHODS FOR MAKING AND USING SAME.)
Spain	2174930

Supplementary Protection Certificates for FLAGYL ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

FLAGYL ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLAGYL ER (Metronidazole)

Introduction to FLAGYL ER

FLAGYL ER, or metronidazole extended release tablets, is a formulation of the antibiotic metronidazole, designed for once-daily dosing. This medication is used to treat various bacterial and protozoal infections, including those affecting the gastrointestinal tract, skin, and genital areas.

Market Size and Growth Projections

The global metronidazole market, which includes FLAGYL ER, is experiencing significant growth driven by several key factors.

• Current Market Size: As of 2023, the metronidazole market was valued at USD 100 million[1].
• Future Projections: The market is expected to grow to USD 139.99 million by 2031, with a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Key Drivers of Market Growth

Increased Prevalence of Infections

The rising incidence of bacterial and protozoal diseases, along with the emergence of antibiotic-resistant strains, is fueling the demand for effective antimicrobial drugs like metronidazole[1].

Affordability and Accessibility

Metronidazole, being a generic drug, is relatively inexpensive and widely accessible, especially in resource-limited settings. This affordability contributes significantly to its market growth[1].

Diverse Applications

Metronidazole is used not only for human infections but also for dental infections and in veterinary medicine, further expanding its market reach[1].

Research and Development

Ongoing R&D efforts focused on innovative formulations and combination therapies are enhancing the market prospects for metronidazole[1].

Product Segmentation

By Application

The metronidazole market is segmented into various application types, including:

• Metronidazole Tablets
• Metronidazole Capsules
• Metronidazole Injections
• Others

FLAGYL ER falls under the category of extended-release tablets, which is a significant segment due to its convenience and efficacy[1][4].

By Product

The market is also segmented by the manufacturing process:

• Glyoxal Process
• Ethidene Diamine Process
• Others

Understanding these segments helps in identifying the specific market dynamics and competitive landscape for FLAGYL ER[1][4].

Geographical Distribution

The global metronidazole market is analyzed across various geographical regions:

• North America: Includes the U.S., Canada, and Mexico.
• Europe: Includes Germany, the UK, France, and the rest of Europe.
• Asia-Pacific: Includes China, Japan, India, and the rest of Asia-Pacific.
• South America
• Middle East & Africa

Each region has its own market dynamics, influenced by local healthcare policies, disease prevalence, and economic conditions[1][4].

Key Players and Competition

The metronidazole market is competitive, with several key players:

• Hongyuan Pharmaceutical
• Unichem Laboratories
• Yinhe Aarti Pharmaceutical
• Zhongan Pharmaceutical
• Wuyao Pharmaceutical
• Saikang Pharmaceutical
• Hongda Pharmaceutical
• Yichang Changjiang Pharmaceutical
• Topsun Pharmaceutical
• Tongji Pharmaceutical
• CordenPharma Farchemia

These companies are involved in various aspects of the market, from manufacturing to distribution, and play a crucial role in shaping the market dynamics[1][4].

Financial Performance of Key Players

Companies like Shionogi Inc., which may not be primary manufacturers of metronidazole but have significant interests in the broader pharmaceutical market, provide insights into the financial health and strategies of the industry.

• Revenue and Profit: Shionogi Inc. reported steady revenue growth, driven by sales of infectious disease drugs, including those related to COVID-19 and other antimicrobial agents. The company's financial performance is influenced by various factors, including royalty income, overseas subsidiaries, and R&D investments[2][5].

Clinical and Pharmacological Aspects of FLAGYL ER

Pharmacokinetics

FLAGYL ER 750 mg tablets are designed for once-daily dosing, with pharmacokinetic parameters similar to those of oral and intravenous metronidazole. The extended-release formulation ensures steady-state levels of the drug in the body, enhancing patient compliance and efficacy[3].

Clinical Studies

Clinical trials have demonstrated the effectiveness and safety of FLAGYL ER. For instance, in multicenter clinical trials, patients treated with FLAGYL ER showed favorable outcomes compared to those treated with intravaginal preparations. Common adverse events included headaches, nausea, and metallic taste, but most were of mild or moderate severity[3].

Market Challenges and Opportunities

Challenges

• Antibiotic Resistance: The increasing resistance to antibiotics poses a significant challenge to the metronidazole market.
• Regulatory Environment: Strict regulatory requirements and the need for continuous R&D to maintain market relevance can be challenging.

Opportunities

• Emerging Markets: Growing healthcare needs in developing regions offer substantial opportunities for market expansion.
• Innovative Formulations: Developing new formulations and combination therapies can help in capturing a larger market share.

Conclusion

The market for FLAGYL ER and other metronidazole formulations is poised for growth, driven by increasing demand for effective antimicrobial drugs, affordability, and diverse applications. Understanding the market dynamics, including segmentation, geographical distribution, and key players, is crucial for navigating this market successfully.

Key Takeaways

• The global metronidazole market is expected to grow from USD 100 million in 2023 to USD 139.99 million by 2031.
• FLAGYL ER is a significant part of this market due to its convenience and efficacy.
• Key drivers include the prevalence of infections, affordability, and ongoing R&D.
• The market is competitive, with several key players involved.
• Clinical and pharmacological aspects of FLAGYL ER highlight its safety and efficacy.

FAQs

What is the current market size of the metronidazole market?

The metronidazole market was valued at USD 100 million in 2023[1].

What is the expected growth rate of the metronidazole market from 2024 to 2031?

The market is expected to grow at a CAGR of 5% from 2024 to 2031[1].

What are the key applications of metronidazole?

Key applications include metronidazole tablets, capsules, injections, and others, as well as use in dental infections and veterinary medicine[1].

Who are the key players in the metronidazole market?

Key players include Hongyuan Pharmaceutical, Unichem Laboratories, Yinhe Aarti Pharmaceutical, and others[1].

What are the pharmacokinetic parameters of FLAGYL ER?

FLAGYL ER 750 mg tablets have pharmacokinetic parameters that allow for once-daily dosing, with steady-state levels similar to oral and intravenous metronidazole[3].

What are the common adverse events associated with FLAGYL ER?

Common adverse events include headaches, nausea, and metallic taste, most of which are mild or moderate in severity[3].

Sources

1. Market Research Intellect: "Global Metronidazole Market Size and Forecast"
2. Shionogi Inc.: "3rd Quarter of Fiscal 2023 Financial Results"
3. FDA: "FLAGYL® (metronidazole) extended release tablets, 750 mg"
4. Industry Research: "Metronidazole Market Dynamics and Forecast 2024"
5. Shionogi Inc.: "1st Quarter of Fiscal 2024 Financial Results"