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Last Updated: March 26, 2026

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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
Malaysia 149142 ADHESIVE PREPARATION ⤷  Start Trial
Japan WO2008016077 貼付剤 ⤷  Start Trial
Australia 2007279643 ⤷  Start Trial
Russian Federation 2008144958 АДГЕЗИВНЫЙ ПРЕПАРАТ ⤷  Start Trial
Taiwan I414299 ⤷  Start Trial
China 101442993 Adhesive preparation ⤷  Start Trial
Singapore 174034 ADHESIVE PREPARATION ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Menthol; methyl salicylate Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Menthol and Methyl Salicylate?

Menthol and methyl salicylate are widely used ingredients in the pharmaceutical, oral care, pain relief, and topical products sectors. Their market growth hinges on demand in these areas, regulatory environments, consumer trends, and manufacturing capacities.

Key Market Drivers

  • Therapeutic Usage: Menthol is used for its cooling sensation and as an active ingredient in cough drops, topical analgesics, and inhalants. Methyl salicylate primarily treats muscular pain and is an ingredient in patches, creams, and ointments.

  • Consumer Preferences: Growing preference for natural and herbal remedies fuels demand for menthol derived from mint oils. Methyl salicylate's popularity persists in analgesic formulations owing to its efficacy.

  • Regulatory Environment: Stringent regulations by agencies like the FDA and European Medicines Agency impact ingredient approval and product formulations. Menthol faces regulation concerning its concentration levels; methyl salicylate is limited due to toxicity at high doses.

  • Regional Trends: North America and Europe maintain significant markets due to established pharmaceutical sectors and consumer healthcare habits. Asia-Pacific shows rapid growth driven by increasing access to healthcare, local manufacturing, and herbal medicine trends.

  • Supply Chain Factors: Menthol production is concentrated in countries like India, China, and the United States. Methyl salicylate is produced via chemical synthesis, with capacity linked to regional demand for over-the-counter pain relief products.

Market Size and Growth Estimates

  • Menthol: Estimated global market valued at approximately $1.4 billion in 2022. Projected compound annual growth rate (CAGR) of 4-5% through 2030. Growth driven by topical analgesic demand and herbal product expansion.

  • Methyl Salicylate: Estimated at $300 million in 2022. CAGR of approximately 3-4% expected over the next decade, reflecting consistent demand in pain relief segments.

Competitive Landscape

  • Major players include Symrise, Givaudan, and Firmenich for natural menthol; BASF, Eastman Chemical, and Clariant for methyl salicylate synthesis.

  • Several regional manufacturers also participate, especially in India and China, emphasizing cost advantages.

Challenges

  • Regulatory Scrutiny: Both ingredients face restrictions due to safety concerns—menthol concentration limits, methyl salicylate toxicity at high doses.

  • Synthetic vs. Natural: Consumer preference shifts toward natural menthol impact product formulations and sourcing strategies.

  • Environmental Concerns: Sustainability practices in menthol extraction (from mint oils) influence market dynamics.

What Is the Financial Trajectory for Menthol and Methyl Salicylate?

Revenue Trends

  • Revenue growth aligns with broader pain management and consumer healthcare sectors. Increasing sales of OTC products in developed countries support steady revenue. Emerging markets contribute to volume increases, although price competition exerts downward pressure.

Cost Structures

  • Menthol production cost varies based on source: natural menthol extraction costs range from $10 to $30 per kilogram, depending on purity and extraction method. Synthetic menthol costs are generally lower, around $6 to $12 per kilogram, influenced by raw material prices.

  • Methyl salicylate manufacturing costs approximate $4 to $8 per kilogram, mainly influenced by chemical synthesis efficiency and raw material prices.

Profitability and Margins

  • Gross margins for companies involved in extraction or synthesis hover between 20% and 40%. Factors influencing margins include raw material costs, regulatory compliance expenses, and market pricing.

  • Pricing pressures due to increased competition and fluctuating raw material costs can restrict profit margins over time.

Investment and R&D Outlook

  • Companies investing in sustainable extraction technologies or novel delivery formats (e.g., transdermal patches for methyl salicylate) aim to secure market share and improve margins.

  • R&D efforts focus on natural derivations, reduced toxicity formulations, and novel delivery mechanisms.

Future Financial Outlook

  • Menthol: Anticipated revenue increase of 4-5% annually through 2030, driven by natural ingredient sourcing and expanding markets in herbal and OTC products.

  • Methyl Salicylate: Expected annual growth of 3-4%, with influence from regulation-driven reformulations and new pain relief formats.

  • Price stability remains complex due to raw material shortages, environmental policies, and evolving regulatory demands.

What Are the Implications for Industry Participants?

  • Manufacturers must monitor regulatory shifts to ensure compliance while maintaining cost efficiencies.

  • Investors should evaluate supply chain resiliency, capacity expansion projects, and R&D pipelines targeting natural and safer formulations.

  • R&D entities focus on deriving sustainable, high-purity sources of menthol and developing lower-toxicity methyl salicylate formulations.

Key Takeaways

  • Menthol's market size in 2022 stands at approximately $1.4 billion, growing at 4-5% CAGR; methyl salicylate's market is around $300 million, growing at 3-4%.

  • Primary drivers include consumer health trends, product innovation, and regional demand growth.

  • Supply chain and regulatory factors significantly influence market stability and profitability.

  • Investment in sustainable extraction, natural derivatives, and novel delivery methods is ongoing.

  • Margins are sensitive to raw material prices, regulatory constraints, and competition.

FAQs

1. How does regional regulation impact menthol and methyl salicylate markets?
Regulations cap concentrations and restrict certain uses, especially for methyl salicylate due to toxicity concerns. These laws affect formulation options, sourcing, and manufacturing costs across regions.

2. What are the main raw materials used in synthetic methyl salicylate production?
Phenol and salicylic acid are key raw materials, with chemical synthesis converting these into methyl salicylate. Raw material prices influence manufacturing costs.

3. How do consumer trends toward natural ingredients influence the market?
Natural menthol derived from mint oils increasingly replaces synthetic sources, affecting supply chains and pricing. Consumers favor products labeled natural, influencing R&D and marketing strategies.

4. What is the outlook for new product development in this sector?
Expect growth in low-toxicity formulations, transdermal delivery systems, and natural extracts, driven by demand for safer, herbal products.

5. Which regions hold the largest market shares for these ingredients?
North America and Europe lead in demand and regulation complexity; Asia-Pacific demonstrates rapid growth in both production and consumption.


Sources

[1] Allied Market Research. "Menthol Market by Application and Region," 2022.
[2] MarketsandMarkets. "Methyl Salicylate Market by Application, Form, and Region," 2022.
[3] U.S. Food and Drug Administration (FDA). "Regulations on Menthol and Methyl Salicylate," 2022.

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