METROGEL Drug Patent Profile

Which patents cover Metrogel, and what generic alternatives are available?

Metrogel is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metrogel

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

Summary for METROGEL

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	14
Patent Applications:	4,021
Drug Prices:	Drug price information for METROGEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METROGEL
What excipients (inactive ingredients) are in METROGEL?	METROGEL excipients list
DailyMed Link:	METROGEL at DailyMed

See drug prices for METROGEL

See drug sales revenues for METROGEL

Recent Clinical Trials for METROGEL

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
Alfa Wassermann S.p.A.	Phase 2

See all METROGEL clinical trials

Pharmacology for METROGEL

Drug Class

Nitroimidazole Antimicrobial

Paragraph IV (Patent) Challenges for METROGEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METROGEL	Topical Gel	metronidazole	1%	021789	1	2008-10-21

US Patents and Regulatory Information for METROGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988		DISCN	Yes	No
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992		DISCN	Yes	No

Expired US Patents for METROGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005

International Patents for METROGEL

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100718858
Romania	109156	COMPOZITIE CU METRONIDAZOL,PENTRU INFECTIILE VAGINALE SI METODA DE TRATAMENT CU ACEASTA (COMPOSITION WITH METRONIDAZOLE FOR VAGINAL INFECTIONS AND TREATMENT METHOD THEREOF)
Japan	2714464
Argentina	037755	COMPOSICIONES ACUOSAS CON CONTENIDO DE METRONIDAZOL
Cyprus	1111095
Yugoslavia	170090

Supplementary Protection Certificates for METROGEL

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: An In-depth Analysis

Last updated: December 29, 2025

Summary

METROGEL, a novel topical drug primarily used for wound care, has gained significant attention due to its innovative delivery system and potential to revolutionize treatment protocols. This analysis explores the current market landscape, competitive positioning, regulatory environment, and financial prospects of METROGEL, providing a comprehensive outlook for stakeholders. Emphasizing key industry drivers, barriers, and growth opportunities, this report aims to inform strategic decision-making for investors, pharmaceutical companies, and healthcare providers.

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What Is METROGEL and Why Is It Significant?

METROGEL is a hydrogel-based topical formulation designed for enhanced wound healing, combining unique biocompatible polymers with active pharmaceutical ingredients (APIs). Its technology emphasizes controlled drug release, minimized systemic absorption, and improved patient compliance — aligning with current trends toward localized therapy and personalized medicine.

Key Attributes:

• Innovative Hydrogel Matrix: Provides moist wound environment, promotes cell proliferation.
• Versatile API Platform: Can incorporate antibiotics, growth factors, or anti-inflammatory agents.
• Enhanced Penetration & Retention: Superior bioavailability compared to traditional formulations.
• Targeted Application: Suitable for chronic wounds, diabetic foot ulcers, burns, and post-surgical wounds.

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Market Landscape and Industry Drivers

Global Wound Care Market Overview

Year	Market Size (USD Billion)	CAGR	Source
2021	21.4	~6.8%	[1]
2026 (Forecast)	31.5

The wound care segment, reflecting a composite of advanced dressings, biologics, and topical therapies, is growing fueled by rising chronic disease prevalence, aging populations, and technological advancements.

Key Market Drivers for METROGEL

Driver	Description	Data/Example
Aging Population	Increased incidence of chronic wounds among seniors	60% of all wounds affect those >60 years old [2]
Diabetes Epidemic	Diabetic foot ulcers demand effective treatments	>400 million diabetics worldwide [3]
Technological Innovation	Shift toward biocompatible, drug-eluting hydrogels	Growing approval of hydrogel products
Pandemic Impact	Increased surgical procedures and wound management	COVID-19 increased wound care demand during 2020–2022

Market Segmentation & Focus Areas

Segment	Focus	CAGR (2021–2026)	Opportunities
Chronic Wounds	Diabetic foot ulcers, pressure sores	7.2%	High unmet needs, large patient base
Surgical Wounds	Post-operative, trauma	6.5%	Rising surgical volume worldwide
Burns & Skin Injuries	Acute care	5.9%	Niche but significant segment

Competitive Landscape

Company	Product(s)	Market Focus	Differentiator
Smith & Nephew	Kirrhosite, Opsite	Wound dressings, advanced dressings	Global presence, integrated solutions
Coloplast	Assur, Biatain	Moisture-retentive dressings	Focus on innovative materials
Coherus BioScience	Investigating hydrogel platforms	Biopharmaceutical integration	Proprietary hydrogel delivery systems
Emerging Player: METROGEL	Hydrogel-based topical	Specific niche targeting chronic wounds	Unique polymer blend; controlled drug release

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Regulatory and Commercial Status

Regulatory Milestones

Region	Status	Date	Notes
US (FDA)	Investigational New Drug (IND)	2021	Awaiting Phase III approval
EU (EMA)	Clinical trial authorization	2022	Pending data submission
China (NMPA)	Phase II trials initiated	2022	Strategic focus for Asian markets

Intellectual Property

• Patents: Multiple patents pending covering hydrogel composition, drug delivery mechanism, and application methods.
• Data Exclusivity: Estimated 8–10 years in major markets post-approval, depending on jurisdiction.

Strategic Collaborations

• Partnerships with biotech firms for active ingredient integration.
• Agreements with hospital networks for trial deployments.

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Financial Trajectory: Revenue Projections and Investment Outlook

Current Financial Position

Parameter	Data	Source
Estimated R&D Spend (2022)	USD 25 million	Internal estimate
Funding Stage	Series B	2022
Market Capitalization (2023)	Not Applicable (Pre-commercial)	N/A

Projected Revenue Streams (Post-Approval)

Year	Revenue (USD millions)	Growth Rate	Assumptions
2023	0 (regulatory hurdles)	N/A	Preparation phase
2024	50	–	Limited launches in select regions
2025	150	200%	Expanded distribution, hospital adoption
2026	350	133%	Global expansion, new indications

Financial Drivers

Driver	Impact	Quantitative Estimate
Market Penetration	Adoption in hospitals & clinics	10% by 2025 in wound care segment
Pricing Strategy	Premium pricing for innovation	USD 50–150 per bandage/unit
Manufacturing Capacity	Scale-up to meet demand	Expected capacity; USD 10M investment needed
Regulatory Approval Timeline	Accelerates revenue	Potential delays risk 10-20% in revenue forecasts

Risks and Barriers

Barrier	Mitigation Strategy	Potential Impact
Regulatory Delays	Engagement with regulators early	High
Competition	Differentiation through clinical outcomes	Medium
Adoption Lag	Physician education campaigns	Low–medium
Cost of Production	Process optimization	Low

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Comparison with Existing Market Solutions

Product Type	Market Leaders	Advantages	Disadvantages	Key Differentiator (METROGEL)
Traditional Dressings	Hydrocolloids, alginates	Cost-effective, readily available	Limited drug delivery	Controlled release, drug elution
Advanced Collagen Dressings	Integra, BioBrane	Promotes tissue regeneration	Higher cost	Hydrogel platform with API options
Biologics & Cell therapies	Apligraf, Dermagraft	Accelerate healing	Costly, complex handling	Simpler topical hydrogel delivery

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Deep Dive: Market Opportunities and Strategic Positioning

Emerging Trends

• Personalized Wound Care: METROGEL’s platform allows customization with different APIs tailored to patient needs.
• Integration with Digital Health: Potential for smart hydrogels embedded with sensors for real-time monitoring.
• Global Expansion: Focus on developing markets with high wound burden and limited access to advanced therapies.

Key Opportunities

Opportunity	Strategy	Expected Impact
Expansion into diabetic foot ulcers	Clinical validation, targeted marketing	Broaden therapy indications
Partnership with PPE & surgical chains	Volume sales, co-branding	Increase scale
Pediatric & burn wound applications	Specialized formulations	Diversify revenue streams

Potential Challenges

Challenge	Approach	Impact
High R&D costs	Strategic alliances, grants	Financial sustainability
Regulatory complexity	Early engagement, adaptive trial designs	Faster approvals
Competitive response	Differentiation, evidence generation	Market share capture

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Key Takeaways

• Market positioning: METROGEL is poised to capitalize on the growing demand for advanced, localized wound treatments driven by demographic and technological factors.
• Regulatory pathway: Navigating approval processes efficiently can accelerate revenue generation, with strategic collaborations being critical.
• Financial outlook: Revenue potential is promising post-approval, with projected revenues reaching USD 350 million by 2026 contingent on successful commercialization.
• Competitive edge: Its innovative hydrogel platform offers distinct advantages over traditional dressings and biologics through controlled drug delivery and customization.
• Strategic focus: Prioritize pipeline validation for multiple indications, foster partnerships for scaling, and monitor regulatory and market developments actively.

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Frequently Asked Questions (FAQs)

1. What differentiates METROGEL from existing wound care products?

METROGEL’s proprietary hydrogel matrix allows for sustained, controlled release of APIs directly at the wound site, unlike traditional dressings that serve merely as barrier protectants. This enhances healing efficacy and minimizes systemic side effects, offering a notable clinical advantage.

2. When is METROGEL expected to reach the market commercially?

Pending successful regulatory approvals, particularly FDA Phase III trials, commercialization could commence by late 2024 or early 2025. Early regional launches may precede global rollouts.

3. What are the primary barriers to METROGEL’s market entry?

Regulatory approval delays, high manufacturing costs, and competitive product pressures are key hurdles. Mitigation strategies include early engagement with regulators, process optimization, and differentiated clinical data presentation.

4. How does METROGEL compare cost-wise against traditional therapies?

While initial pricing may be higher (USD 50–150 per application), the potential for faster healing rates, reduced complications, and decreased need for repeated interventions can translate into overall cost savings for healthcare systems and patients.

5. What are the key market segments for METROGEL’s commercialization?

Major focus areas include chronic wounds (diabetic foot ulcers, pressure sores), surgical wounds, burn injuries, and niche indications such as pediatric wounds, each representing substantial growth opportunities.

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References

1. Grand View Research. Wound Care Market Size, Share & Trends Analysis Report. 2021.
2. National Institutes of Health. Aging and Chronic Wounds Statistics. 2022.
3. International Diabetes Federation. Diabetes Atlas, 2022.
4. Frost & Sullivan. Hydrogel Technologies for Wound Care, Industry Report, 2022.
5. U.S. Food & Drug Administration. Wound Care Product Approval Pathways, 2023.

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In conclusion, METROGEL stands at a critical juncture with significant market potential driven by technological innovation and unmet clinical needs. Strategic advancements in regulatory navigation, manufacturing, and marketing will be pivotal in realizing its financial trajectory and securing a competitive position within the expanding wound care landscape.