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Last Updated: December 17, 2025

Hisamitsu Company Profile


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Summary for Hisamitsu
International Patents:54
US Patents:8
Tradenames:2
Ingredients:2
NDAs:2

Drugs and US Patents for Hisamitsu

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 SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No 11,813,364 ⤷  Get Started Free Y ⤷  Get Started Free
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No 10,022,445 ⤷  Get Started Free Y ⤷  Get Started Free
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes Yes 9,687,474 ⤷  Get Started Free Y ⤷  Get Started Free
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-003 Oct 11, 2019 RX Yes No 11,813,364 ⤷  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

International Patents for Hisamitsu Drugs

Country Patent Number Estimated Expiration
South Korea 101420450 ⤷  Get Started Free
Taiwan 201410272 ⤷  Get Started Free
Taiwan I594771 ⤷  Get Started Free
Poland 2878300 ⤷  Get Started Free
Canada 2652220 ⤷  Get Started Free
Taiwan 201410270 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2008016077 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Hisamitsu Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 10C0056 France ⤷  Get Started Free PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 C300461 Netherlands ⤷  Get Started Free PRODUCT NAME: ASENAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MALEAAT; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317 SPC/GB10/046 United Kingdom ⤷  Get Started Free PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Hisamitsu – Market Position, Strengths & Strategic Insights

Last updated: July 30, 2025


Introduction

Hisamitsu Pharmaceutical Inc. stands as a formidable player within the global dermatological and topical medication sector. With a legacy rooted in Japan’s traditional medicine complemented by innovative drug delivery systems, Hisamitsu has carved a significant niche in the competitive pharmaceutical landscape. This analysis delineates its market positioning, core strengths, strategic initiatives, and opportunities amid evolving industry dynamics.


Market Position and Industry Footprint

Hisamitsu operates predominantly in topical analgesics, dermatological products, and a broad portfolio of transdermal medication delivery systems. Its flagship product, Salonpas, a topical analgesic patch, commands a dominant share in North America, Asia, and other regions. According to market reports, Hisamitsu's global revenue surpasses USD 1 billion, with a significant proportion derived from the American and Asian markets [1].

The company’s strategic focus on non-prescription (OTC) formulations and innovative delivery methods aligns with industry shifts toward consumer-centric, minimally invasive therapies. Notably, Hisamitsu’s penetration into the U.S. OTC segment positions it as a leading firm in pain management topical solutions.


Core Strengths

1. Robust Product Portfolio & Brand Recognition

Hisamitsu boasts a diversified line of topical analgesics, skin therapies, and transdermal systems. The Salonpas brand enjoys unparalleled recognition, underpinned by decades of consumer trust and regulatory approvals across key markets. Its emphasis on evidence-based efficacy and safety supports sustained consumer loyalty.

2. Innovation in Transdermal Technologies

The company invests heavily in advanced drug delivery systems—microneedle patches, nanotechnology-enabled formulations—that enhance bioavailability and targeted therapy. Such innovation provides a competitive edge by addressing limitations of oral medication, such as systemic side effects.

3. Market Penetration and Distribution Capabilities

Hisamitsu exhibits strong distribution networks through strategic partnerships with pharmacy chains, hospitals, and retail outlets. Its agile supply chain facilitates rapid market entry and expansion, especially in emerging markets where topical formulations are gaining popularity.

4. Regulatory Acumen and Quality Standards

With rigorous adherence to regulatory standards (FDA, EMA, PMDA), Hisamitsu maintains high product quality and compliance, enabling smoother approvals and international expansion.

5. Focus on Consumer Health and Wellness Trends

Aligning with the increasing demand for non-invasive, OTC therapies, Hisamitsu’s product strategy emphasizes pain relief, skin care, and wellness segments, appealing to a broad demographic.


Strategic Insights and Growth Opportunities

A. Geographic Expansion in Emerging Markets

Despite a strong North American and Japanese presence, Heisamitsu’s potential in regions like Southeast Asia, Africa, and Latin America remains underexploited. Tailoring products to regional preferences and regulatory landscapes can accelerate growth.

B. Innovation and R&D Investment

Continued innovation in minimally invasive delivery systems—such as wearable patches and microneedle arrays—can sustain technological leadership. Collaborations with biotech firms may facilitate access to novel materials and formulations.

C. Diversification into Adjacent Therapeutic Areas

Expanding into dermatological conditions beyond pain relief—such as anti-inflammatory and anti-aging skincare—offers diversification and hedging against market saturation.

D. Digital Engagement and Direct-to-Consumer Models

Leveraging telehealth, mobile apps, and e-commerce can enhance consumer engagement, facilitate educational campaigns, and capture the growing digital health market.

E. Strategic Partnerships and Mergers & Acquisitions

Forming alliances with local pharmaceutical companies and considering acquisitions can accelerate market access, broaden product offerings, and bolster R&D capabilities.


Competitive Landscape Dynamics

Hisamitsu’s primary competitors include Johnson & Johnson (e.g., Bengay), Pfizer (e.g., Icy Hot), and local pharmaceutical leaders in targeted markets. The competitive edge stems from proprietary formulations, innovative drug delivery methods, and brand loyalty. However, increasing regulatory scrutiny, rising raw material costs, and competition from generic formulations challenge profit margins.

Emerging players focusing on plant-based ingredients and sustainable formulations are also altering the competitive matrix. To maintain its leadership, Hisamitsu must continue emphasizing innovation, consumer engagement, and strategic expansion.


Regulatory and Market Trends

  • Regulatory Evolution: Stringent safety and efficacy data requirements necessitate ongoing R&D and compliance efforts.

  • Consumer Preferences: Growing demand for natural ingredients and eco-friendly packaging influences product development.

  • Healthcare Trends: Shift toward personalized medicine and remote healthcare services is prompting tailored topical therapies and digital health integration.


Conclusion

Hisamitsu maintains a commanding position within the topical and dermatological pharmaceutical industry owing to its strong brand portfolio, technological innovation, and strategic distribution. Its future growth hinges on geographic expansion, continued R&D investment, and adaptation to evolving consumer and regulatory landscapes. Sustained focus on innovation and strategic partnerships will be vital in navigating intensifying competition.


Key Takeaways

  • Market Position: Hisamitsu is a leading global provider of topical analgesics, with a significant share in North American and Asian markets.
  • Strengths: Diversified product portfolio, innovative drug delivery, robust distribution, and regulatory expertise.
  • Growth Opportunities: Expansion into emerging markets, technological innovation, diversification into new therapeutic areas, and digital engagement.
  • Challenges: Regulatory complexities, raw material costs, and rising competitive pressures.
  • Strategic Focus: Invest in R&D, foster partnerships, adapt to consumer trends, and leverage technological advancements to sustain competitive advantage.

FAQs

Q1: What distinguishes Hisamitsu’s product offerings from competitors?
A1: Hisamitsu’s emphasis on innovative transdermal delivery systems, combined with strong brand recognition like Salonpas, differentiates its products by offering effective, minimally invasive pain relief solutions with proven safety profiles.

Q2: How is Hisamitsu positioning itself in emerging markets?
A2: The company is pursuing geographic diversification through tailored marketing strategies, establishing local partnerships, and adhering to regional regulatory frameworks to expand its footprint in Southeast Asia, Africa, and Latin America.

Q3: What technological innovations does Hisamitsu focus on?
A3: Hisamitsu invests in microneedle patches, nanotechnology-enabled formulations, and wearable transdermal systems to improve drug bioavailability, patient compliance, and therapeutic outcomes.

Q4: What are the main threats facing Hisamitsu in the near term?
A4: Increasing regulatory hurdles, price competition from generics, raw material inflation, and emerging natural or plant-based competitors pose significant risks to Hisamitsu’s profitability.

Q5: How can Hisamitsu leverage digital health trends?
A5: By developing digital platforms for consumer education, telehealth partnerships, and personalized topical therapy solutions, Hisamitsu can enhance consumer engagement and adapt to the digital healthcare ecosystem.


References

[1] MarketWatch. "Hisamitsu Pharmaceutical Inc. Revenue & Industry Analysis," 2023.

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