You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

MENTHOL; METHYL SALICYLATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 9,233,184 ⤷  Get Started Free Y ⤷  Get Started Free
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No 9,233,184 ⤷  Get Started Free Y ⤷  Get Started Free
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes 8,809,615 ⤷  Get Started Free Y ⤷  Get Started Free
>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 Menthol and Methyl Salicylate in the Pharmaceutical Industry

Last updated: July 28, 2025

Introduction

Menthol and methyl salicylate are significant compounds within the pharmaceutical, food, cosmetic, and consumer healthcare sectors. Their widespread usage stems from their therapeutic, flavoring, and aromatic properties. Understanding the market dynamics and financial trajectory of these compounds provides critical insights for industry stakeholders, including manufacturers, investors, and policymakers. This report delineates current market trends, growth drivers, challenges, and future forecasts, with a focus on the pharmaceutical context.

Overview of Menthol and Methyl Salicylate

Menthol

Menthol is a naturally occurring monoterpenoid alcohol primarily derived from peppermint and other mint oils. It is prized for its cooling sensation and anesthetic properties, making it a staple in cough syrups, topical analgesics, respiratory inhalers, and oral care products. According to a recent report, global menthol market revenue was valued at approximately USD 790 million in 2021, with an expected compound annual growth rate (CAGR) of around 5.2% through 2028 [[1]].

Methyl Salicylate

Methyl salicylate, or wintergreen oil, is an ester of salicylic acid. It functions mainly as a flavoring agent, counterirritant, and topical analgesic. The global methyl salicylate market was estimated at USD 250 million in 2020, with a projected CAGR of 4.8% up to 2027 [[2]]. Its pharmaceutical applications are largely centered on topical pain relief formulations, owing to its counterirritant properties.

Market Dynamics

Supply Chain and Raw Material Availability

The supply of menthol is predominantly derived from natural sources—peppermint oil and other mint species. Climate variability, agricultural challenges, and geopolitical tensions influence raw material availability, causing price volatility. Synthetic menthol, produced via chemosynthesis (turpentine or oil-based processes), has gained prominence to stabilize supply chains and reduce costs. However, natural menthol commands a premium due to consumer preference for plant-derived products.

Similarly, methyl salicylate’s supply depends on wintergreen plant extracts and synthetic processes. Environmental concerns and sustainability initiatives are pushing the industry toward more sustainable extraction and synthesis methods, potentially influencing costs and supply stability.

Regulatory Environment

Global regulatory frameworks significantly impact market dynamics. Agencies such as the FDA, EMA, and other regional bodies regulate the permissible uses and purity standards of menthol and methyl salicylate. Stringent safety and environmental standards, especially regarding synthetic production, influence manufacturing practices and costs.

Consumer Preferences and Market Drivers

The demand for natural and organic products fuels growth in natural menthol and methyl salicylate variants. Consumers increasingly prioritize products with clean labels and sustainable sourcing. Additionally, the extensive use of these compounds in over-the-counter (OTC) analgesics and cold remedies remains a robust growth driver, especially amid aging populations and increased awareness of self-care.

Pharmaceutical and Healthcare Applications

Menthol’s analgesic and antipruritic properties have sustained demand in topical formulations. Its role as a permeability enhancer improves drug absorption, further boosting pharmaceutical applications. Methyl salicylate's prominent role as a topical analgesic and anti-inflammatory agent sustains its market presence. The global rise in musculoskeletal disorders, sports injuries, and chronic pain cases propels demand in these sectors.

Competitive Landscape

Multiple players dominate the market, comprising large chemical companies and specialty ingredient manufacturers. Notable firms include Symrise AG, Givaudan, Mane, Firmenich, and Sensient Technologies, among others. Innovation in formulation, sustainable sourcing, and cost-effective synthesis are key competitive strategies.

Financial Trajectory and Future Outlook

Historical Growth and Revenue Trends

Between 2015 and 2020, the combined global market value for menthol and methyl salicylate experienced steady growth, averaging around 4.9% CAGR, propelled by rising healthcare expenditure and expanding applications. The COVID-19 pandemic temporarily interrupted supply chains but also underscored the importance of respiratory and analgesic products, reinforcing market resilience [[1], [2]].

Forecasted Growth and Market Penetration

Analysts project the global menthol market will reach roughly USD 1.15 billion by 2028, growing at a CAGR of 5.2%. Methyl salicylate is expected to grow slightly slower, reaching approximately USD 370 million by 2027 at a CAGR of 4.8%. Pharmaceutical applications, particularly topical analgesics, will remain core growth drivers, accounting for an estimated 60-65% of global demand by 2030.

Emerging Trends Influencing Financial Growth

  • Sustainable and Natural Sourcing: Increasing consumer and regulatory emphasis on natural products is driving investment into eco-friendly extraction and synthesis, with higher profit margins for naturally sourced compounds.
  • Innovative Delivery Systems: Advances in formulation technology—such as transdermal patches and enhanced bioavailability topical gels—are expanding therapeutic effectiveness and market size.
  • Geographical Expansion: Emerging markets in Asia-Pacific (India, China, Southeast Asia) demonstrate rapid growth in consumption, driven by increasing healthcare access and consumer awareness.
  • R&D and Proprietary Formulations: Investment in research for new therapeutic indications and patent protection is expected to enhance revenue streams and market exclusivity.

Risks and Challenges

  • Regulatory Hurdles: Stricter safety standards, especially concerning synthetic production residues, could increase compliance costs.
  • Raw Material Price Volatility: Climate change-induced fluctuations impact natural supply, affecting procurement costs.
  • Market Saturation: Mature markets in North America and Europe face limited growth potential; companies seek diversification and innovation.
  • Competition from Synthetic Substitutes: While natural variants command premium prices, synthetic compounds may offer cost advantages, pressuring profit margins.

Strategic Implications for Industry Stakeholders

Companies should consider diversifying sourcing strategies, investing in sustainable production, and expanding R&D to develop novel formulations that enhance therapeutic efficacy. Mergers and acquisitions in the natural ingredients space present opportunities to strengthen market position. Additionally, engaging with regulatory bodies proactively ensures compliance and smoother market entry.

Conclusion

The market for menthol and methyl salicylate remains robust within the pharmaceutical sector, underpinned by consistent demand for topical analgesics, respiratory aids, and flavoring agents. Although faces challenges such as raw material volatility and regulatory pressures, ongoing innovation, sustainable sourcing, and expanding applications—especially in emerging markets—are poised to bolster financial growth trajectories. Stakeholders who adapt to these evolving dynamics and invest strategically in R&D and supply chain resilience will position themselves favorably in the expanding market landscape.


Key Takeaways

  • The global market for menthol and methyl salicylate is growing at approximately 5% annually, driven by pharmaceutical and consumer healthcare demands.
  • Natural sourcing and sustainable production processes are increasingly vital, influencing costs and market positioning.
  • The prevalence of chronic pain and respiratory conditions sustains demand for topical analgesics containing these compounds.
  • Emerging markets in Asia-Pacific are critical to future growth, offering opportunities for expansion and revenue diversification.
  • Investment in formulation innovation and regulatory compliance will be decisive for competitive advantage.

FAQs

1. What factors primarily influence the price volatility of menthol?
Menthol prices are chiefly affected by raw material availability, climate variability impacting peppermint harvests, geopolitical factors, and shifts toward synthetic production to stabilize supply.

2. How does consumer preference for natural products impact methyl salicylate markets?
A rising preference for natural and organic ingredients elevates demand for naturally derived methyl salicylate, often commanding higher prices and influencing sourcing strategies.

3. What regulatory challenges do pharmaceutical manufacturers face with these compounds?
Manufacturers must adhere to safety, purity, and environmental standards set by agencies like the FDA and EMA. Synthetic variants face scrutiny over residual contaminants, impacting formulation and manufacturing processes.

4. How is innovation influencing the future of these markets?
Formulation advances, such as transdermal delivery systems and enhanced bioavailability products, expand therapeutic applications, driving revenue growth and market competitiveness.

5. What strategic moves should investors consider in these markets?
Investors should focus on companies investing in sustainable sourcing, R&D in new formulations, and expansion in high-growth emerging markets, aligning with evolving consumer and regulatory trends.


References

[1] MarketWatch. "Menthol Market Size, Share & Trends Analysis Report." 2022.
[2] Fortune Business Insights. "Methyl Salicylate Market Size, Share & Industry Analysis." 2021.

More… ↓

⤷  Get Started Free

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.