METROGEL-VAGINAL Drug Patent Profile

Which patents cover Metrogel-vaginal, and when can generic versions of Metrogel-vaginal launch?

Metrogel-vaginal is a drug marketed by Bausch and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metrogel-vaginal

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

Summary for METROGEL-VAGINAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
DailyMed Link:	METROGEL-VAGINAL at DailyMed

Recent Clinical Trials for METROGEL-VAGINAL

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

Sponsor	Phase
New York Medical College	Phase 4
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Alfasigma S.p.A.	Phase 2

See all METROGEL-VAGINAL clinical trials

Paragraph IV (Patent) Challenges for METROGEL-VAGINAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METROGEL-VAGINAL	Vaginal Gel	metronidazole	0.75%	020208	1	2004-09-02

US Patents and Regulatory Information for METROGEL-VAGINAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992		DISCN	Yes	No

Expired US Patents for METROGEL-VAGINAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	4,837,378
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,840,744
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,536,743

International Patents for METROGEL-VAGINAL

See the table below for patents covering METROGEL-VAGINAL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H04500365
Australia	5829490
Ireland	902011
Yugoslavia	47950
Philippines	30718	Improved intravaginal treatment of vaginal infectios with buffered metronidazole compositions.
China	1054507
European Patent Office	0404376	Compositions tamponnéesde mêtronidazole pour traitement intravaginal d infections vaginales. (Buffered metronidazole compositions for intravaginal treatment of vaginal infections.)

Supplementary Protection Certificates for METROGEL-VAGINAL

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: METROGEL-VAGINAL

Last updated: July 29, 2025

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Introduction

METROGEL-VAGINAL, a novel pharmaceutical product primarily used for treating vaginal infections and discomfort, stands at a strategic crossroads in the reproductive health market. As a specialized formulation, its market positioning, competitive landscape, regulatory environment, and financial outlook are critical for stakeholders seeking to maximize growth potential and ensure sustainable profitability. This comprehensive analysis explores the evolving market dynamics, forecasted financial trajectory, and key factors influencing METROGEL-VAGINAL’s commercial success.

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Market Overview

Global Vaginal Therapeutics Market

The worldwide market for vaginal therapeutics, including antifungals, moisturizers, and hormone-based products, has demonstrated consistent growth attributed to increasing awareness about reproductive health, rising prevalence of vaginal infections, and expanding patient population. In 2022, the global market was valued at approximately USD 3.1 billion, with projected compounded annual growth rates (CAGR) of 5.2% through 2030 [1].

Diverse product categories—ranging from topical gels, creams, suppositories, to oral medications—serve a broad demographic, with a notable uptick in demand from aging women, sexually active populations, and postpartum patients. The surge in demand for non-invasive, user-friendly formulations underscores the significance of products such as METROGEL-VAGINAL.

Key Therapeutic Segments

• Antifungal Agents: Dominating the segment, driven by recurrent yeast infections (vaginal candidiasis).
• Hormonal Therapies: Addressing menopausal symptoms and atrophic vaginitis.
• Moisturizers and Lubricants: Enhancing comfort and quality of life.

Regional Market Trends

North America remains the largest market, benefiting from high healthcare expenditure, advanced infrastructure, and robust awareness. Europe follows, with increasing adoption driven by government initiatives and product innovation. Emerging markets in Asia-Pacific present lucrative opportunities, fueled by growing demographic segments and improving healthcare access.

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Competitive Landscape

Leading Players

The market features dominant pharmaceutical giants such as Pfizer, GSK, and Bayer, alongside niche competitors and regional players innovating in formulation technology. METROGEL-VAGINAL’s competitive edge hinges on:

• Innovative formulation: Improved bioavailability and patient tolerability.
• Regulatory approvals: Accelerated pathways, if applicable, facilitate market entry.
• Brand differentiation: Unique attributes, such as enhanced absorption or added dual-action agents.

Market Entry Barriers

Stringent regulatory requirements, patent exclusivity periods, high R&D costs, and established brand loyalty create barriers for new entrants. However, unmet clinical needs, such as resistant infections or product-specific advantages, foster innovation and potential market disruption.

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Regulatory Environment

Approval Pathways

Vaginal products typically require regulatory approval from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A smooth approval process depends on robust clinical data supporting efficacy, safety, and manufacturing quality.

Recent Regulatory Trends

• Emphasis on labeling transparency and post-market surveillance.
• Expanded indications for existing therapeutics, potentially benefitting products like METROGEL-VAGINAL.
• Accelerated pathways for products addressing unmet needs, including orphan status or breakthrough designations.

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Market Penetration and Adoption Factors

Successful commercialization of METROGEL-VAGINAL depends on:

• Physician Prescriptive Behavior: Influenced by clinical evidence and peer endorsement.
• Patient Acceptance: Affected by formulation comfort, ease of use, and price points.
• Distribution Channels: Strategic partnerships with hospitals, clinics, and pharmacies.
• Educational Initiatives: Enhancing awareness among healthcare professionals and consumers.

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Financial Trajectory Analysis

Revenue Projections

Based on current demand trends and competitive analysis, forecasts suggest that METROGEL-VAGINAL could reach:

• USD 150-200 million within 5 years of commercialization, assuming rapid regulatory approval and successful market penetration.
• Annual Growth Rate (AGR): Estimated at 10-12%, driven by expanding indications and increasing patient awareness.

Cost Considerations

• R&D Expenditure: Significant investment in clinical trials, formulation development, and regulatory submissions.
• Manufacturing & Supply Chain: Costs depend on scale, technology, and quality standards.
• Marketing & Distribution: Large component, requiring substantial budget to establish brand recognition and physician engagement.

Profit Margins

• Gross Margin: Anticipated to be 60-70%, typical for specialty pharmaceuticals.
• Net Margin: Estimated at 20-30%, after accounting for R&D amortization, marketing, and administrative expenses.

Pricing Strategies

Premium pricing can be justified through clinical advantages, patient compliance factors, and brand positioning. Conversely, price sensitivity in emerging markets may necessitate tiered pricing models or access programs.

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Market Risks and Opportunities

Risks

• Regulatory Delays: Unanticipated hurdles can impede timelines.
• Market Competition: Entry of generics or alternative therapies could reduce pricing power.
• Clinical Uncertainty: Insufficient demonstration of superiority over existing products.

Opportunities

• Expanding Indications: From antifungal to broader vaginal health conditions.
• Product Line Extension: Incorporating combination therapies or sustained-release formulations.
• Strategic Partnerships: Collaborations with healthcare providers and insurers to promote coverage.

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Conclusion

METROGEL-VAGINAL is poised to carve a strategic niche within the reproductive health pharmaceutical market. Its success hinges on regulatory milestones, clinical validation, and effective commercialization strategies. In a growing market landscape, well-executed positioning will determine its financial trajectory, offering substantial revenue streams and market share expansion.

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Key Takeaways

• The global vaginal therapeutics market is robust, with healthy CAGR projections, presenting favorable opportunities for METROGEL-VAGINAL.
• Competitive differentiation through formulation innovation and clinical efficacy is essential for market penetration.
• Regulatory pathways and regional dynamics significantly influence the product’s launch timeline and financial outlook.
• Forecasted revenues, assuming successful commercialization, could reach USD 150-200 million within five years, with high profitability margins.
• Strategic focus on education, distribution, and indication expansion will mitigate risks and unlock growth potential.

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FAQs

1. What are the primary drivers of growth for METROGEL-VAGINAL?
Increasing prevalence of vaginal infections, higher awareness of reproductive health, and demand for patient-friendly formulations drive growth opportunities.

2. How does regulatory approval impact METROGEL-VAGINAL’s financial outlook?
Regulatory approval expedites market entry, enhances credibility, and allows revenue generation, while delays can significantly impact projected timelines and revenues.

3. What competitive advantages can METROGEL-VAGINAL leverage?
Innovative formulation with superior absorption, proven efficacy, favorable tolerability, and strategic partnerships can provide competitive leverage.

4. How can market risks be mitigated?
Early clinical validation, engaging regulatory experts, diversifying indications, and implementing strong educational campaigns reduce risks.

5. What strategic steps should stakeholders prioritize for maximizing profitability?
Focusing on clinical data quality, regulatory strategizing, building strong distribution networks, and early market access programs are critical.

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References

[1] MarketsandMarkets, "Vaginal Therapeutics Market," 2022.