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Last Updated: April 8, 2025

Sawai Usa Company Profile


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What is the competitive landscape for SAWAI USA

SAWAI USA has three approved drugs.



Drugs and US Patents for Sawai Usa

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sawai Usa DIMETHYL FUMARATE dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210285-001 Dec 21, 2021 DISCN No No ⤷  Try for Free ⤷  Try for Free
Sawai Usa MIRABEGRON mirabegron TABLET, EXTENDED RELEASE;ORAL 209446-001 Dec 27, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-001 Feb 3, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-002 Feb 3, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-003 Feb 3, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
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Pharmaceutical Competitive Landscape Analysis: Sawai USA – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. This analysis focuses on Sawai USA, a key player in the generic drug market, examining its market position, strengths, and strategic insights. As the U.S. subsidiary of Japan's Sawai Pharmaceutical Co. Ltd., Sawai USA has made significant strides in establishing itself as a formidable competitor in the world's largest pharmaceutical market.

Sawai's Entry into the U.S. Market

Sawai Pharmaceutical Co. Ltd. made a bold move in June 2017 by acquiring Upsher-Smith Laboratories, LLC for $1.05 billion[1]. This acquisition marked Sawai's full-scale entry into the U.S. generic pharmaceuticals market, the largest in the world. The deal provided Sawai with:

  • A portfolio of 30 approved drugs in the U.S., primarily oral solid dose products
  • A pipeline of about 30 products
  • Two manufacturing facilities in Minnesota and Denver
  • Approximately 500 employees

This strategic acquisition allowed Sawai to establish a significant presence in the U.S. market quickly, leveraging Upsher-Smith's existing infrastructure and reputation.

Market Position

Sawai USA, operating under the Upsher-Smith name, has positioned itself as a specialty generic drug company focused on generic drugs and small brands[9]. This positioning allows the company to:

  1. Leverage Upsher-Smith's unique commercial capabilities
  2. Focus on more challenging products to differentiate from competitors
  3. Capitalize on Sawai's research and development capabilities

The company's market position is strengthened by its ability to combine Sawai's intellectual property and R&D capabilities with Upsher-Smith's manufacturing base, strong distribution network, and established commercial relationships[10].

Strengths and Competitive Advantages

1. Research and Development Capabilities

Sawai brings excellent patent research and analysis capabilities to its U.S. operations[6]. This strength allows the company to:

  • Develop formulations that are difficult for competitors to replicate
  • Create products that are easy for patients to use
  • Launch new products quickly, capturing market share and differentiating from competitors

2. Manufacturing Capacity

One of the most-important issues in a pharmaceutical industry deeply linked to human lives is the stable supply of high-quality pharmaceutical products, and we are proud that our Company is capable of producing industry-leading volume of about 15 billion tablets a year.[6]

Sawai's impressive manufacturing capacity ensures a stable supply of high-quality pharmaceuticals, a critical factor in the life-related pharmaceutical industry. The company aims to increase its production capacity to 20 billion tablets per year by the end of fiscal 2020[6].

3. Diverse Product Portfolio

Sawai USA benefits from an ample lineup of products, inherited from Upsher-Smith and expanded through new product launches. In June 2020, Sawai announced the launch of 14 generic drugs with 29 strengths[3], demonstrating its commitment to expanding its product offerings in the U.S. market.

4. Strong Distribution Network

Upsher-Smith's established distribution network and commercial relationships provide Sawai USA with a solid foundation for growth in the U.S. market[1]. These relationships are crucial for ensuring product availability and market penetration.

5. Financial Backing

As a subsidiary of Sawai Pharmaceutical Co. Ltd., Sawai USA benefits from the financial strength of its parent company. This financial backing supports future growth strategies and allows for significant investments in research, development, and manufacturing capabilities[6].

Strategic Insights

1. Focus on Specialty Generics

Sawai USA's strategy revolves around becoming a specialty generic drug company. This approach allows the company to:

  • Target niche markets with less competition
  • Develop more complex formulations that command higher margins
  • Leverage Upsher-Smith's commercial capabilities in specific therapeutic areas

2. Aggressive Product Launch Strategy

The company plans to launch over 30 new products in the next three years[9]. This aggressive strategy aims to:

  • Expand market share
  • Diversify the product portfolio
  • Increase revenue streams

3. Investment in Manufacturing Infrastructure

Sawai is investing approximately ¥13.0 billion over three years to construct a new factory that will consolidate Upsher-Smith's production functions[9]. This investment is expected to:

  • Increase productivity
  • Improve future profitability
  • Enhance manufacturing capabilities for more complex products

4. Leveraging Global Synergies

Sawai USA benefits from its parent company's global presence and expertise. The company aims to:

  • Introduce Sawai's products to the U.S. market
  • Leverage Sawai's state-of-the-art manufacturing technology
  • Explore opportunities to bring Upsher-Smith's medicines to new markets, including Japan[10]

5. Strategic Partnerships

In 2017, Sawai sold a 20% stake in its U.S. subsidiary to Sumitomo Corporation of Americas[5]. This strategic alliance aims to:

  • Leverage Sumitomo's experience and network in global business
  • Enhance sourcing of active pharmaceutical ingredients (APIs)
  • Facilitate product introductions

Challenges and Future Outlook

While Sawai USA has established a strong foundation in the U.S. market, it faces several challenges:

  1. Intense Competition: The U.S. generic drug market is highly competitive, with numerous established players and new entrants.

  2. Pricing Pressures: Generic drug manufacturers face ongoing pressure to reduce prices, potentially impacting profit margins.

  3. Regulatory Environment: Navigating the complex U.S. regulatory landscape requires significant resources and expertise.

  4. Market Dynamics: The generic drug market in the U.S. is changing rapidly, requiring agile strategies and continuous innovation[9].

Despite these challenges, Sawai USA's future outlook appears promising. The company's focus on specialty generics, commitment to research and development, and strategic investments in manufacturing capabilities position it well for sustainable growth in the U.S. market.

Key Takeaways

  • Sawai USA, operating as Upsher-Smith, has established a strong presence in the U.S. generic drug market through strategic acquisition and investment.
  • The company's strengths include robust R&D capabilities, significant manufacturing capacity, a diverse product portfolio, and strong distribution networks.
  • Sawai USA's strategy focuses on specialty generics, aggressive product launches, and investments in manufacturing infrastructure.
  • The company leverages global synergies with its parent company and strategic partnerships to enhance its competitive position.
  • While facing challenges such as intense competition and pricing pressures, Sawai USA is well-positioned for future growth in the U.S. pharmaceutical market.

FAQs

  1. Q: How did Sawai enter the U.S. pharmaceutical market? A: Sawai entered the U.S. market by acquiring Upsher-Smith Laboratories, LLC for $1.05 billion in June 2017.

  2. Q: What is Sawai USA's main focus in the U.S. market? A: Sawai USA focuses on becoming a specialty generic drug company, targeting niche markets and developing complex formulations.

  3. Q: How many new products does Sawai USA plan to launch in the near future? A: The company plans to launch over 30 new products in the next three years.

  4. Q: What significant investment is Sawai making in its U.S. operations? A: Sawai is investing approximately ¥13.0 billion over three years to construct a new factory that will consolidate Upsher-Smith's production functions.

  5. Q: How does Sawai USA benefit from its parent company's global presence? A: Sawai USA leverages its parent company's R&D capabilities, manufacturing technology, and global market experience to enhance its competitive position in the U.S. market.

Sources cited:

  1. https://www.fiercepharma.com/m-a/japan-s-sawai-gets-u-s-production-1b-deal-for-upsher-smith-gencerics
  2. https://www.upsher-smith.com/news/sawai-launches-14-generic-drugs-with-29-strengths/
  3. https://global.sawai.co.jp/news/detail/81
  4. https://global.sawai.co.jp/upload/files/2017_01.pdf
  5. https://global.sawaigroup.holdings/ir/library/integrated_report/pdf/2021.pdf
  6. https://www.upsher-smith.com/news/japans-sawai-pharmaceutical-to-acquire-the-generics-business-of-u-s-upsher%E2%80%90smith-laboratories/

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