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. Sixty-seven 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	5,536,743
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,840,744

International Patents for METROGEL-VAGINAL

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	170090
European Patent Office	0404376	Compositions tamponnéesde mêtronidazole pour traitement intravaginal d infections vaginales. (Buffered metronidazole compositions for intravaginal treatment of vaginal infections.)
South Africa	9004413
Denmark	0404376

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 METROGEL-VAGINAL

Last updated: February 14, 2026

Current Market Position and Product Profile

METROGEL-VAGINAL is a formulation of metronidazole used for treating bacterial vaginosis (BV), a common vaginal infection. It is delivered via vaginal gel, aligning with local drug delivery preferred for this indication. The product is typically marketed for its efficacy, tolerability, and localized action that reduces systemic side effects.

Market Size and Growth

The global bacterial vaginosis treatment market, valued at approximately USD 750 million in 2022, is projected to expand at a compound annual growth rate (CAGR) of 4.5% through 2030. This growth is driven by increased awareness, rising prevalence, and improving healthcare access.

The vaginal drugs segment accounts for roughly 40% of this market, with products like METROGEL-VAGINAL competing against other metronidazole formulations and alternative treatments such as clindamycin cream and oral therapies.

Key Market Drivers

• Prevalence of Bacterial Vaginosis: Affects up to 30% of women aged 15-44 globally, leading to higher demand for effective treatments.
• Patient Preference for Localized Therapy: Topical gels are favored for their targeted action and fewer systemic side effects.
• Healthcare Awareness and Screening: Increasing screening rates for BV in primary care and gynecology settings promote treatment utilization.
• Regulatory Approvals and Reimbursement: Positive regulatory outcomes, such as approvals by FDA and EMA, enhance market access. Reimbursement policies favoring topical products support sales.

Competitive Landscape

Major competitors include:

Product	Manufacturer	Formulation	Market Share (Est.)	Status
Metrogel Vaginal	GyneLogix	Gel (0.75%)	20%	Market leader
Clindesse	皇冠医药	Cream (2%)	15%	Mature product
Flagyl Vaginal Gel	Tris Pharma	Gel (0.75%)	10%	Generic alternative
Oral Metronidazole	Generic	Tablets	20%	Broad-spectrum use

Entry barriers include patent protections for certain formulations, regulatory approvals, and established clinical evidence supporting efficacy.

Regulatory and Reimbursement Outlook

Regulatory approvals in major markets, including the US and EU, underpin sales stability. Reimbursement policies typically favor topical applications for BV, especially when supported by robust clinical data. Pricing strategies aim at competitive positioning, with indications for both prescription and potential over-the-counter (OTC) status in select markets.

Financial Trajectory

The financial outlook for METROGEL-VAGINAL depends on:

• Market Penetration: Achieving at least 10-15% of the vaginal BV market within 3-5 years, translating to USD 75-100 million in annual revenues based on current market valuation.
• Pricing Strategy: Setting competitive prices around USD 30-50 per treatment course, aligned with existing products.
• Manufacturing and Distribution Costs: Maintaining margins while ensuring supply chain robustness is vital.
• Patent Life and Generic Competition: Patent expirations forecast in 2-4 years could introduce generics, potentially reducing prices by 30-50%.
• R&D Investment: Ongoing development of improved formulations or combination therapies could prolong market exclusivity and revenue streams.

Risk Factors

• Increased commoditization due to generics could erode margins.
• Market saturation from existing competitors limits growth potential.
• Regulatory hurdles or delays may affect product launch timelines in key markets.
• Variability in clinical guidelines may influence prescribing behaviors.

Future Opportunities

• Extending indications to include recurrent BV or other vaginal infections.
• Developing OTC formulations to broaden access.
• Incorporation into combination products with probiotics or other agents to enhance efficacy.
• Geographic expansion into emerging markets with rising healthcare infrastructure.

Concluding Summary

METROGEL-VAGINAL is positioned within a stable yet competitive market, leveraging local delivery benefits for BV treatment. Its financial trajectory hinges on market penetration, patent protection, and competitive dynamics. The growth outlook remains moderate, with opportunities tied to product differentiation, geographic expansion, and regulatory developments.

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Key Takeaways

• The global market for BV treatments is growing at approximately 4.5% annually, with topical formulations representing a significant segment.
• METROGEL-VAGINAL holds roughly 20% market share among vaginal BV treatments, with revenues potentially reaching USD 75-100 million annually upon targeted market penetration.
• Patent expirations within the next 2-4 years could lead to increased generic competition and pricing pressures.
• Strategic approaches include expanding indications, developing OTC versions, and entering emerging markets for growth.
• The financial success of METROGEL-VAGINAL depends on balancing market share growth, competitive positioning, and managing patent lifecycle risks.

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FAQs

1. What factors influence the market share of METROGEL-VAGINAL?
Market share depends on clinical efficacy, patient acceptance, regulatory approvals, pricing, and the extent of generic competition.

2. How does patent expiration impact METROGEL-VAGINAL’s revenue potential?
Patents limiting generic entry protect revenues. Once expired, generics can reduce prices and market share, pressuring profits unless the brand maintains differentiation.

3. What geographic markets offer the best growth prospects?
Developed markets in North America and Europe provide stable revenues; emerging markets in Asia and Latin America show potential due to rising healthcare infrastructure and awareness.

4. How significant is the competition from oral metronidazole?
Oral formulations are cost-effective but have systemic side effects. Topical gels like METROGEL-VAGINAL compete primarily on tolerability and localized treatment efficacy.

5. What strategic moves can enhance METROGEL-VAGINAL’s market position?
Investment in formulation improvements, expanding indications, entering OTC space, and proactive patent management will strengthen market presence.

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Sources

1. MarketsandMarkets, "Bacterial Vaginosis Market," 2022.
2. GlobalData, "Female Healthcare Market," 2021.
3. FDA, "Regulatory Status of Topical BV Treatments," 2022.
4. IQVIA, "Pharmaceutical Market Trends," 2022.
5. Company filings and product labels (as available).