SALONPAS Drug Patent Profile

When do Salonpas patents expire, and when can generic versions of Salonpas launch?

Salonpas is a drug marketed by Hisamitsu Pharm Co and is included in one NDA. There are two patents protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the menthol; methyl salicylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Salonpas

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 3, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SALONPAS

International Patents:	20
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
DailyMed Link:	SALONPAS at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SALONPAS

Constraining patent/regulatory exclusivity:

8,809,615

NDA:

022029

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 SALONPAS

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

Sponsor	Phase
Scilex Pharmaceuticals, Inc.	Phase 1

See all SALONPAS clinical trials

US Patents and Regulatory Information for SALONPAS

SALONPAS is protected by two US patents.

This potential generic entry date is based on patent 8,809,615.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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		Y
Hisamitsu Pharm Co	SALONPAS	menthol; methyl salicylate	PATCH;TOPICAL	022029-002	Nov 5, 2012		OTC	Yes	No	8,809,615		Y
Hisamitsu Pharm Co	SALONPAS	menthol; methyl salicylate	PATCH;TOPICAL	022029-001	Feb 20, 2008		OTC	Yes	Yes	8,809,615		Y
Hisamitsu Pharm Co	SALONPAS	menthol; methyl salicylate	PATCH;TOPICAL	022029-002	Nov 5, 2012		OTC	Yes	No	9,233,184		Y

International Patents for SALONPAS

When does loss-of-exclusivity occur for SALONPAS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hungary

Japan

Malaysia

Mexico

New Zealand

Russian Federation

Singapore

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SALONPAS around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E047985
Russian Federation	2441649	АДГЕЗИВНЫЙ ПРЕПАРАТ (ADHESIVE PRODUCT)
European Patent Office	2047845	PRÉPARATION ADHÉSIVE (ADHESIVE PREPARATION)
Taiwan	200817013	Adhesive preparation
Australia	2007279643
Singapore	174034	ADHESIVE PREPARATION
South Korea	101420450

Market Dynamics and Financial Trajectory of SALONPAS: An In-Depth Analysis

Last updated: November 7, 2025

Introduction

SALONPAS, a well-established topical analgesic brand, has maintained a significant presence in the over-the-counter pain relief market for decades. Recognized primarily for its transdermal patch and topical formulations containing active ingredients such as menthol, methyl salicylate, and camphor, SALONPAS is a product of preventive and symptomatic treatment for musculoskeletal pain. As the pharmaceutical landscape evolves with advancing formulation technologies, regulatory shifts, and changing consumer preferences, understanding the market dynamics and financial trajectory of SALONPAS becomes critical for stakeholders. This analysis dissects current trends, market drivers, competitive landscape, regulatory influences, and financial prospects shaping SALONPAS's future.

---

Market Overview and Segmentation

The global topical analgesics market was valued at approximately USD 4.5 billion in 2022 and is projected to grow CAGR of around 5% through 2028. SALONPAS occupies a significant segment within over-the-counter (OTC) analgesics, with broad distribution across pharmacies, convenience stores, and online platforms. Its primary market regions include North America, Europe, and Asia-Pacific, where musculoskeletal pain prevalence and self-medication culture drive demand.

Product Portfolio: SALONPAS offers various formulations, including medicated patches, topical creams, and gels. These cater to different consumer needs, such as ease of use, targeted pain relief, and safety profiles, contributing to its diversified market outreach.

---

Market Dynamics

1. Increasing Prevalence of Musculoskeletal Disorders

Global aging populations and sedentary lifestyles contribute to rising incidences of arthritis, back pain, and sports injuries. According to WHO, musculoskeletal conditions account for approximately 20% of global disability-adjusted life years (DALYs). This escalation fosters sustained demand for OTC analgesics like SALONPAS.

2. Consumer Preference for Non-Opioid Pain Relief

Growing concerns over opioid addiction and side effects underpin a shift towards topical, non-systemic analgesics. SALONPAS’s perception as a safe, over-the-counter option enhances its market appeal, especially among women, older adults, and athletes emphasizing non-invasive pain management.

3. Product Innovation and Line Extension

Innovation in formulation technology—such as patches with enhanced drug delivery systems—bolsters consumer preference and efficacy. Introduction of skin-friendly, hypoallergenic, and fast-acting variants expands SALONPAS’s market share amid increasing competition.

4. Regulatory Environment

In major markets, regulatory bodies such as the FDA (U.S.) and EMA (Europe) increasingly scrutinize OTC products for efficacy and safety. Stricter labeling, quality standards, and approval processes influence R&D investment and product lifecycle management.

5. Competitive Landscape

Key competitors include Icy Hot, Biofreeze, Bengay, and various generics. Patent expirations on certain active ingredients and formulations create opportunities for market entrants but also intensify price competition. Brand loyalty and distribution channels significantly influence market position.

---

Financial Trajectory

1. Revenue Trends

Historical revenue data suggest steady growth driven by consistent demand for topical analgesics in OTC channels. In North America, SALONPAS’s parent company recorded annual revenues exceeding USD 150 million from analgesic segments, with OTC formulations comprising a significant share. The introduction of new variants and expansion into emerging markets have contributed to revenue boosts.

2. Profitability Metrics

Profit margins for OTC analgesic products like SALONPAS depend on raw material costs, marketing expenses, and regulatory compliance. Gross margins have historically hovered around 60–70%, with net profit margins approximately 20%. Cost efficiencies and global distribution expansion could further optimize profitability.

3. Market Penetration and Growth

Emerging markets such as India, China, and Brazil present high-growth opportunities due to their expanding middle class and rising health awareness. Localization strategies, price sensitivity management, and robust distribution channels are pivotal to capturing market share.

4. Impact of Formulation and Packaging Innovations

Investments in enhanced delivery systems, such as long-lasting patches and combination formulations, could command premium pricing and drive revenue uplifts. Moreover, eco-friendly packaging responding to consumer sustainability trends offers brand differentiation.

5. Risks and Challenges

Market saturation, regulatory hurdles, counterfeit products, and price wars constitute potential headwinds. Fluctuations in raw material prices, especially for menthol and methyl salicylate, impact margins. The COVID-19 pandemic initially disrupted supply chains but also increased self-medication tendencies, temporarily boosting OTC analgesics sales.

---

Future Outlook and Strategic Considerations

1. Digital and E-Commerce Expansion

Enhanced digital marketing, telehealth integration, and online sales channels are critical. Digital platforms provide direct engagement with consumers, fostering brand loyalty. E-commerce growth is accelerating, accounting for up to 30% of OTC analgesic sales in certain markets.

2. Regulatory and Patent Strategies

Proactive compliance and strategic patent litigation or licensing can safeguard market position. Leveraging intellectual property rights on formulation innovations ensures a competitive edge.

3. Investment in R&D

Developing novel formulations with improved efficacy and reduced side effects can differentiate SALONPAS. Collaborations with biotech firms and academia for ingredient innovation are advisable.

4. Market Diversification

Expanding into adjacent indications—such as nerve pain or dermatological conditions—and new geographical markets can mitigate risks associated with market saturation in mature regions.

---

Conclusion

The strategic positioning of SALONPAS in the growing OTC topical analgesics domain hinges on several intertwined market forces. The increasing burden of musculoskeletal disorders, consumer shift towards non-opioid pain relief, and ongoing innovations provide a robust growth impetus. Financially, with prudent market expansion, formulation enhancement, and cost management, SALONPAS has promising upward trajectory prospects. However, navigating regulatory complexities and competitive pressures remains essential for sustained success.

---

Key Takeaways

• The global OTC topical analgesics market projected at a 5% CAGR until 2028 offers growth opportunities for SALONPAS, particularly through expansion in emerging markets and digital channels.
• Rising musculoskeletal disorder prevalence and consumer preference for non-opioid, OTC pain relief bolster demand.
• Innovation in formulations and packaging enhances SALONPAS’s market competitiveness and profitability.
• Regulatory compliance and patent management are vital to maintain market share amid competition.
• Diversification and technological advancements are necessary to sustain long-term growth trajectories.

---

FAQs

Q1: How does SALONPAS differentiate itself from other OTC analgesic products?
A1: SALONPAS leverages its well-established brand reputation, innovative delivery systems such as long-lasting patches, and a broad product portfolio targeting various consumer needs, differentiating itself through efficacy and convenience.

Q2: What are the primary growth regions for SALONPAS?
A2: The primary growth regions include North America, Europe, and Asia-Pacific, especially developing markets like India and China, driven by rising musculoskeletal issues and increasing health awareness.

Q3: How do regulatory changes impact SALONPAS's market trajectory?
A3: Stricter regulations necessitate compliance with safety and efficacy standards, potentially increasing R&D costs and delaying product launches but ultimately ensuring consumer trust and market sustainability.

Q4: What role does e-commerce play in SALONPAS’s growth?
A4: E-commerce platforms facilitate direct consumer interaction, expanding reach, especially among tech-savvy and younger demographics, and account for a significant share of OTC sales.

Q5: What are the main risks facing SALONPAS’s future growth?
A5: Risks include regulatory hurdles, market saturation, counterfeit competition, raw material price volatility, and shifts in consumer preferences.

---

References

[1] Transparency Market Research. "Topical Analgesics Market," 2022.
[2] World Health Organization. "Musculoskeletal Conditions," 2021.
[3] Statista. "Over-the-Counter (OTC) Analgesics Market Revenue," 2022.