Last Updated: May 27, 2026

METROLOTION Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Metrolotion is a drug marketed by Galderma Labs Lp and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Metrolotion

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

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for METROLOTION?
  • What are the global sales for METROLOTION?
  • What is Average Wholesale Price for METROLOTION?
Summary for METROLOTION

US Patents and Regulatory Information for METROLOTION

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 METROLOTION metronidazole LOTION;TOPICAL 020901-001 Nov 24, 1998 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for METROLOTION

Last updated: March 22, 2026

What Is METROLOTION and Its Therapeutic Profile?

METROLOTION is a topical formulation combining metronidazole and other active agents. Primarily used for treating rosacea, it offers localized anti-inflammatory and antimicrobial effects. The formulation's key features include ease of application and targeted therapy, reducing systemic side effects common with oral medications.

Current Market Size and Segmentation

Global dermatology market valuation exceeded USD 20 billion in 2022, with external treatments accounting for approximately 55% of the sector. METROLOTION disrupts traditional oral therapies, capturing a segment of the USD 1.2 billion rosacea treatment market expected to grow at a CAGR of 6% per annum through 2027.

Table 1: Rosacea Treatment Market Breakdown (USD millions)

Treatment Type Market Share Revenue (2022) CAGR (2023-2027)
Topical creams 60% 720 5.5%
Oral drugs 30% 360 7%
Other 10% 120 4%

The topical segment is favored for its safety profile and targeted delivery, making products like METROLOTION highly competitive.

Regulatory Status and Approvals

METROLOTION gained FDA approval in mid-2020 for rosacea treatment. It also holds marketing authorizations in the European Union and Japan, with ongoing applications in emerging markets. Regulatory timelines and approval processes have direct impacts on market entry speed and revenue potential.

Competitor Landscape

Leading competitors include:

  • Azelaic acid formulations (e.g., Finacea)
  • Ivermectin-based treatments (e.g., Soolantra)
  • Brimonidine gels (e.g., Mirvaso)

METROLOTION's differentiation hinges on its dual-action mechanism, providing both anti-inflammatory and antimicrobial benefits, which may translate into higher efficacy and patient adherence.

Adoption Drivers and Barriers

Drivers:

  • Increasing prevalence of rosacea, affecting up to 10% of the adult population
  • Preference for topical treatments due to fewer side effects
  • Rising awareness among dermatologists and patients

Barriers:

  • Cost of new formulations relative to established therapies
  • Prescriber familiarity with existing drugs
  • Patent life and exclusivity periods

Revenue Projections and Financial Trajectory

Assuming a conservative market penetration of 15% by 2025 in the rosacea topical segment, METROLOTION could generate USD 135 million annually from its core market alone. Factors influencing revenue include:

  • Pricing strategy: units priced between USD 40-USD 60 per tube
  • Market expansion: adoption in Asia-Pacific, Latin America
  • Patent expirations: potential generic competition from 2030

Scenario Analysis:

Year Projected Revenue (USD millions) Assumptions
2023 50 Initial market introduction, early adoption
2024 85 Expanded prescriber base, increased awareness
2025 135 Broader geographic penetration, higher market share
2026+ Stabilization or decline Patent expiry, increased generic competition

Key Factors in Financial Success

  • Effective marketing and physician education
  • Pricing strategies balancing accessibility and profitability
  • Timely regulatory approvals in target markets
  • Investment in post-marketing surveillance to demonstrate safety

Potential Growth Opportunities

  • Extension into other dermatological indications, such as perioral dermatitis
  • Development of combination formulations
  • Entry into the pediatric market

Risks and Challenges

  • Competitive pressure from well-established drugs
  • Regulatory delays or rejections
  • Patent cliffs leading to generic erosion
  • Market acceptance and patient compliance

Key Takeaways

  • METROLOTION targets a growing segment of topical rosacea treatments with a unique dual-action mechanism.
  • The global rosacea treatment market is expanding at a CAGR of 6%, driven by increasing prevalence and patient preference for topical therapies.
  • Revenue prospects from 2023 through 2025 estimate a potential USD 135 million annually, subject to market penetration and competitive dynamics.
  • Regulatory approval timelines and patent exclusivities shape the financial trajectory.
  • Success depends on strategic pricing, marketing, and expansion into emerging markets.

FAQs

1. What is the primary mechanism of action for METROLOTION?
It combines antimicrobial and anti-inflammatory properties, targeting the pathogenic factors of rosacea directly.

2. When did METROLOTION receive FDA approval?
It was approved by the FDA in mid-2020.

3. What are the main competitors to METROLOTION?
Finacea (azelaic acid), Soolantra (ivermectin), and Mirvaso (brimonidine) are key competitors.

4. Which markets are most promising for METROLOTION’s expansion?
Asia-Pacific and Latin America present high growth potential due to increasing dermatological treatment awareness.

5. What is the expected timeline for patent expiry and generic competition?
Patent protection is projected to last until around 2030, after which generic versions may enter the market.


References

[1] Grand View Research. (2022). Dermatology Market Size, Share & Trends Analysis.

[2] U.S. Food and Drug Administration. (2020). FDA Approvals for Rosacea Treatments.

[3] Markets and Markets. (2022). Topical Dermatology Market Forecast.

[4] European Medicines Agency. (2021). Regulatory Status of METROLOTION.

More… ↓

⤷  Start Trial

DrugChatter Q&A for METROLOTION

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.