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Last Updated: December 27, 2024

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 8,809,615 ⤷  Subscribe Y ⤷  Subscribe
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No 9,233,184 ⤷  Subscribe Y ⤷  Subscribe
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-001 Feb 20, 2008 OTC Yes Yes 9,233,184 ⤷  Subscribe Y ⤷  Subscribe
Hisamitsu Pharm Co SALONPAS menthol; methyl salicylate PATCH;TOPICAL 022029-002 Nov 5, 2012 OTC Yes No 8,809,615 ⤷  Subscribe Y ⤷  Subscribe
>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
Hungary E047985 ⤷  Subscribe
South Korea 20090035474 ADHESIVE PREPARATION ⤷  Subscribe
Spain 2755027 ⤷  Subscribe
Brazil PI0712396 preparação de adesivo ⤷  Subscribe
European Patent Office 2047845 PRÉPARATION ADHÉSIVE (ADHESIVE PREPARATION) ⤷  Subscribe
South Korea 101420450 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

MENTHOL; METHYL SALICYLATE Market Analysis and Financial Projection Experimental

Methyl Salicylate Market Dynamics and Financial Trajectory

Introduction to Methyl Salicylate

Methyl salicylate, a compound known for its anti-inflammatory and analgesic properties, is widely used in various industries, including pharmaceuticals, food and beverage, and cosmetics. Here, we delve into the market dynamics and financial trajectory of methyl salicylate, highlighting its growth drivers, challenges, and future projections.

Market Size and Growth Projections

The global methyl salicylate market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 212.2 million and is projected to reach USD 458.19 million by 2036, growing at a CAGR of 6.1% during the forecast period of 2024-2036[1].

Another report indicates that the market size was valued at USD 238 million in 2023 and is expected to reach USD 387 million by 2031, growing at a CAGR of 4% from 2024 to 2031[3].

Growth Drivers

Pharmaceutical Industry

The pharmaceutical sector is a major driver of the methyl salicylate market. Its use in pain-relieving creams, ointments, and patches for treating arthritis and other muscular pains is significant. Methyl salicylate is a key ingredient in topical analgesics, and its demand is increasing due to the growing need for effective pain management solutions[1][3][4].

Food and Beverage Industry

In the food and beverage sector, methyl salicylate is used as a flavoring agent in products like chewing gums, candies, and mints. This application contributes to the market's growth, especially as consumer demand for flavored products remains high[1].

Cosmetics and Personal Care

The cosmetics and personal care industry also drives the demand for methyl salicylate. It is used in skincare products, hair care products, and perfumes due to its pleasant smell and skin-soothing qualities. The growing awareness and concern for skin and hair care, particularly through social media, further boost its demand[1][4].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is expected to witness noteworthy growth due to the expansion of hair and skin care industries, as well as the high manufacturing of salicylic acid and related products in countries like China and India. China, in particular, has one of the largest pharmaceutical industries in the world, which significantly contributes to the growth of the methyl salicylate market[1].

North America and Europe

In North America and Europe, the market for methyl salicylate is driven by the presence of vast hair care and skin care industries. These regions have a high demand for personal care products, which includes skincare and haircare items that often contain methyl salicylate. Government investments in the pharmaceutical industry in these regions also support market growth[1][4].

Challenges and Restraints

Side Effects and Toxicity

One of the significant challenges facing the methyl salicylate market is the concern over its side effects and toxic nature. Excessive external application can lead to intoxication, irritation of the stomach lining, and blistering of the skin. These risks can slow down market growth if not properly managed[4].

Regulatory Considerations

Regulatory scrutiny is another challenge. For instance, the FDA has set guidelines for the use of methyl salicylate, particularly in terms of systemic absorption and potential salicylate toxicity. Adherence to these regulations is crucial for market participants[2].

Financial Trajectory

The financial trajectory of the methyl salicylate market is positive, driven by its diverse applications and growing demand. Here are some key financial highlights:

  • Market Size: Expected to grow from USD 212.2 million in 2023 to USD 458.19 million by 2036[1].
  • CAGR: Projected to grow at a CAGR of 6.1% from 2024 to 2036[1].
  • Revenue Growth: The market is anticipated to reach USD 387 million by 2031, growing at a CAGR of 4% from 2024 to 2031[3].

Key Applications and Their Impact

Pharmaceutical Applications

Methyl salicylate is widely used in the pharmaceutical industry for its analgesic and anti-inflammatory properties. It is a crucial component in pain-relieving patches, creams, and ointments. For example, the SALONPAS® Pain Relief Patch, which contains 10% methyl salicylate and 3% L-menthol, has been approved by the FDA for treating mild to moderate pain[2].

Food and Beverage Applications

In the food and beverage sector, methyl salicylate serves as a flavoring agent, adding fragrance and flavor to various products. This application is significant and contributes to the market's growth[1].

Cosmetics and Personal Care Applications

Methyl salicylate is used in skincare products, hair care products, and perfumes due to its pleasant smell and skin-soothing qualities. The growing demand for natural and organic products in these industries further drives the market[1][4].

Research and Development

Continuous research and development efforts are crucial for the growth of the methyl salicylate market. These efforts focus on reducing the risks associated with methyl salicylate, such as salicylate toxicity, and on broadening its application areas. For instance, studies have been conducted to determine the efficacy and safety profile of methyl salicylate in combination with other ingredients like menthol[5].

Consumer Preferences and Market Trends

The growing preference for natural and sustainable components in personal care products is a significant trend driving the methyl salicylate market. Consumers are increasingly aware of the benefits of natural ingredients, which has led to an increased demand for products containing methyl salicylate derived from plants[3].

Key Takeaways

  • The methyl salicylate market is driven by its applications in the pharmaceutical, food and beverage, and cosmetics industries.
  • The market is expected to grow significantly, with a projected CAGR of 6.1% from 2024 to 2036.
  • Regional growth is notable in the Asia Pacific, North America, and Europe due to expanding industries and consumer demand.
  • Challenges include side effects and regulatory considerations, which must be managed to sustain market growth.
  • Continuous R&D and consumer preferences for natural products are key factors in the market's financial trajectory.

FAQs

Q1: What are the primary applications of methyl salicylate? Methyl salicylate is primarily used in the pharmaceutical industry for pain relief, in the food and beverage industry as a flavoring agent, and in the cosmetics and personal care industry for skincare and haircare products.

Q2: What is the projected market size of methyl salicylate by 2036? The methyl salicylate market is projected to reach USD 458.19 million by 2036[1].

Q3: What are the key growth drivers for the methyl salicylate market? Key growth drivers include the growing demand in the pharmaceutical industry, the food and beverage sector, and the cosmetics and personal care industry, as well as the increasing preference for natural and sustainable products.

Q4: What are the potential challenges facing the methyl salicylate market? Challenges include the potential side effects and toxicity of methyl salicylate, as well as regulatory considerations that must be adhered to.

Q5: How does the Asia Pacific region contribute to the growth of the methyl salicylate market? The Asia Pacific region, particularly countries like China and India, contributes significantly due to the expansion of hair and skin care industries and the high manufacturing of salicylic acid and related products[1].

Sources

  1. Research Nester: Methyl Salicylates Market Analysis, Growth Report-2036.
  2. FDA: N22-029S012 Methyl salicylate Clinical 2 PREA.
  3. Market Research Intellect: Methyl Salicylate Market Size, Trends and Projections.
  4. Persistence Market Research: Methyl Salicylate Market Structure Analysis for the Period 2015 - 2021.
  5. PubMed: Efficacy and safety profile of a topical methyl salicylate and menthol.

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