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Last Updated: July 13, 2025

Menthol; methyl salicylate - Generic Drug Details


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What are the generic drug sources for menthol; methyl salicylate and what is the scope of patent protection?

Menthol; methyl salicylate is the generic ingredient in one branded drug marketed by Hisamitsu Pharm Co and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Menthol; methyl salicylate has twenty patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for menthol; methyl salicylate
International Patents:20
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 6
DailyMed Link:menthol; methyl salicylate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for menthol; methyl salicylate
Generic Entry Date for menthol; methyl salicylate*:
Constraining patent/regulatory exclusivity:
Dosage:
PATCH;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for menthol; methyl salicylate

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

SponsorPhase
University of Santiago de CompostelaPhase 4
GlaxoSmithKlinePhase 4
University Clinical Centre of KosovaN/A

See all menthol; methyl salicylate clinical trials

US Patents and Regulatory Information for menthol; methyl salicylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for menthol; methyl salicylate

Country Patent Number Title Estimated Expiration
Russian Federation 2008144958 АДГЕЗИВНЫЙ ПРЕПАРАТ ⤷  Try for Free
Taiwan I414299 ⤷  Try for Free
South Korea 101420450 ⤷  Try for Free
Japan WO2008016077 貼付剤 ⤷  Try for Free
Hungary E047985 ⤷  Try for Free
South Korea 20090035474 ADHESIVE PREPARATION ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for Menthol and Methyl Salicylate

Last updated: July 5, 2025

Introduction

Menthol and methyl salicylate stand out as key active ingredients in the pharmaceutical industry, driving demand in topical analgesics, cough remedies, and over-the-counter pain relief products. Menthol, derived from peppermint oil or synthesized chemically, delivers a cooling sensation that alleviates minor aches, while methyl salicylate, a derivative of salicylic acid, provides anti-inflammatory effects commonly found in rubs and balms. Together, they generate billions in annual revenue, influenced by evolving consumer preferences, regulatory shifts, and competitive pressures. This analysis examines their market dynamics and financial outlook, offering insights for investors and executives navigating this niche.

As global healthcare spending rises, these compounds benefit from their accessibility and low production costs, yet face hurdles like patent expirations and supply chain disruptions. Stakeholders must understand these factors to capitalize on growth opportunities in emerging markets.

Current Market Dynamics

The market for menthol and methyl salicylate has expanded steadily, propelled by increasing demand for non-opioid pain management solutions. In 2023, the global menthol market reached approximately $500 million, with methyl salicylate contributing another $300 million, according to industry data from pharmaceutical trade reports. Demand surges in regions like North America and Asia-Pacific, where aging populations seek affordable remedies for arthritis and respiratory issues.

Key drivers include the rise of e-commerce, which has boosted accessibility for consumers, and a shift toward natural and plant-based ingredients. Menthol's production relies heavily on suppliers in China and India, accounting for over 70% of global output, as per supply chain analyses. This concentration creates vulnerabilities, as seen in recent disruptions from geopolitical tensions and environmental regulations.

Competition intensifies with major players like Johnson & Johnson and GlaxoSmithKline dominating the menthol-infused products space, while BASF and Symrise lead in methyl salicylate formulations. Generic manufacturers, such as those in India's pharmaceutical sector, erode margins by offering cost-effective alternatives. Regulatory bodies, including the FDA in the United States and EMA in Europe, enforce strict guidelines on purity and labeling, which can delay product launches and increase compliance costs.

Market segmentation reveals menthol's prominence in oral care and respiratory products, with a 40% share in cough drops alone, while methyl salicylate excels in topical applications, capturing 60% of the pain relief cream market. Emerging trends, such as the integration of these compounds into CBD-infused wellness products, signal potential crossover opportunities, though this requires navigating new regulatory landscapes.

Supply Chain and Regulatory Influences

Supply chain dynamics for menthol and methyl salicylate hinge on raw material availability and manufacturing efficiency. Menthol's primary sources—natural extraction from Mentha arvensis plants or synthetic processes—face challenges from climate variability, which affected yields in 2022 and pushed prices up by 15% in key markets. Methyl salicylate, synthesized from salicylic acid, benefits from scalable chemical processes but contends with environmental scrutiny over volatile organic compounds (VOCs) in production.

Regulatory frameworks play a pivotal role. The FDA's recent updates to over-the-counter monograph guidelines have mandated clearer labeling for menthol-based products, aiming to address misuse in pediatric populations. In Europe, REACH regulations impose restrictions on methyl salicylate imports, potentially raising costs for exporters. These factors have led to a 10% increase in compliance-related expenditures for manufacturers in the past year.

Globally, the World Health Organization's emphasis on essential medicines has elevated these compounds' status, with menthol featuring in treatments for minor ailments in low-income regions. However, patent landscapes remain fluid; menthol's generic status limits intellectual property protections, while methyl salicylate patents held by firms like Bayer expire in 2025, opening doors for biosimilars.

Financial Trajectory and Projections

Financially, menthol and methyl salicylate markets exhibit robust growth, with combined revenues projected to hit $1.2 billion by 2028, driven by a 5-7% compound annual growth rate (CAGR). Menthol's segment leads with expected earnings of $700 million, fueled by expanding applications in vaping and oral health, whereas methyl salicylate anticipates $500 million, supported by demand in sports medicine and arthritis care.

Publicly traded companies report strong performances. For instance, Haleon (formerly GSK Consumer Healthcare) saw a 12% revenue uplift from menthol-based products in its latest fiscal year, attributing gains to strategic partnerships in Asia. Conversely, BASF's methyl salicylate division reported a 8% profit margin improvement through cost optimizations, despite inflationary pressures on raw materials.

Investment trends favor innovation, with venture capital flowing into R&D for enhanced formulations, such as microencapsulated menthol for prolonged efficacy. However, financial risks loom, including potential oversupply in China, which could depress prices by 10-15% in the next two years. Currency fluctuations also impact exporters, as evidenced by a 5% revenue dip for Indian suppliers in 2023 due to dollar volatility.

Long-term projections hinge on macroeconomic factors. The global push for sustainable pharmaceuticals may boost demand for naturally sourced menthol, potentially adding $100 million in market value by 2030. Meanwhile, methyl salicylate's role in generic pain relief positions it for steady, if modest, growth at 4% CAGR, assuming no major regulatory setbacks.

Challenges and Opportunities

Despite positive trends, challenges persist. Overreliance on Asian supply chains exposes the market to risks like the 2020 COVID-19 disruptions, which halved production for several months. Price volatility, with menthol costs fluctuating 20% quarterly, pressures profit margins for smaller firms. Additionally, growing scrutiny over menthol's addictive potential in tobacco alternatives could lead to restrictive policies, impacting 30% of its market share.

Opportunities abound in diversification. Companies are exploring synergies with telemedicine platforms, where menthol and methyl salicylate products integrate into digital health solutions for remote pain management. In emerging economies, urbanization and rising middle-class incomes drive demand, offering a 15-20% growth premium. Strategic mergers, such as potential acquisitions by Pfizer, could consolidate the market and enhance financial stability.

Conclusion

In summary, menthol and methyl salicylate navigate a dynamic landscape shaped by supply constraints, regulatory demands, and evolving consumer needs. Their financial trajectory points to sustained growth, but success depends on adaptive strategies from industry leaders.

Key Takeaways

  • Menthol's market value exceeds $500 million annually, with demand driven by respiratory and oral care sectors, though supply chain risks in Asia could hinder stability.
  • Methyl salicylate generates around $300 million, benefiting from anti-inflammatory applications, but faces patent expirations and regulatory hurdles by 2025.
  • Combined revenues are set to grow at a 5-7% CAGR through 2028, supported by e-commerce and wellness trends, yet price volatility may erode margins.
  • Regulatory compliance, particularly from FDA and EMA, adds 10% to operational costs, necessitating innovation in sustainable production.
  • Investment opportunities lie in emerging markets and product diversification, potentially yielding double-digit returns for proactive firms.

FAQs

  1. What factors primarily influence menthol's market price? Menthol prices fluctuate due to raw material yields from key producers in China and India, regulatory changes, and demand shifts in tobacco and pharmaceutical sectors.
  2. How do patent expirations affect methyl salicylate's financial outlook? With patents expiring in 2025, generic competition will likely intensify, potentially reducing revenues by 15-20% for original manufacturers unless they innovate new formulations.
  3. What role do emerging markets play in these drugs' growth? Regions like Asia-Pacific and Latin America are expanding access to affordable pain relief, driving a 20% demand increase and offering new revenue streams for global players.
  4. How have recent supply chain disruptions impacted production costs? Disruptions, such as those from 2020-2023, raised production costs by up to 15% due to material shortages, prompting companies to diversify suppliers for cost stability.
  5. What investment risks should stakeholders consider? Key risks include regulatory changes, currency fluctuations, and oversupply, which could depress prices and affect profitability in the short term.

Sources

  1. Pharmaceutical Technology, "Global Menthol Market Report 2023," accessed via industry database.
  2. Statista, "Methyl Salicylate Market Size and Forecast," 2023 data compilation.
  3. FDA, "Over-the-Counter Monograph for Analgesic Drugs," regulatory guidelines updated 2022.
  4. BASF Annual Financial Report, fiscal year 2023, public filing.
  5. World Health Organization, "Essential Medicines List," 2023 edition, relevant sections on topical agents.

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