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Last Updated: December 16, 2025

Daiichi Company Profile


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Summary for Daiichi
International Patents:331
US Patents:25
Tradenames:4
Ingredients:4
NDAs:4
PTAB Cases with Daiichi as patent owner: See PTAB cases with Daiichi as patent owner

Drugs and US Patents for Daiichi

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No 7,893,075 ⤷  Get Started Free Y ⤷  Get Started Free
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No 10,941,142 ⤷  Get Started Free Y ⤷  Get Started Free
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No 10,730,876 ⤷  Get Started Free Y ⤷  Get Started Free
Daiichi Sankyo Inc VANFLYTA quizartinib dihydrochloride TABLET;ORAL 216993-002 Jul 20, 2023 RX Yes Yes 8,357,690 ⤷  Get Started Free ⤷  Get Started Free
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No 8,404,700 ⤷  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
Paragraph IV (Patent) Challenges for DAIICHI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 15 mg, 30 mg and 60 mg ➤ Subscribe 2019-01-28

Supplementary Protection Certificates for Daiichi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1405852 15C0068 France ⤷  Get Started Free PRODUCT NAME: EDOXABAN,UN SEL,SOLVATE OU N-OXYDE DE CELUI-CI,EN PARTICULIER L'EDOXABAN TOSYLATE; REGISTRATION NO/DATE: EU/1/15/993 20150619
1405852 300760 Netherlands ⤷  Get Started Free PRODUCT NAME: EDOXABAN, EEN ZOUT DAARVAN, EEN SOLVAAT DAARVAAN OF EEN N-OXIDE DAARVAN, IN HET BIJZONDER EDOXABAN TOSYLAAT; REGISTRATION NO/DATE: EU/1/15/993 20150619
1405852 92835 Luxembourg ⤷  Get Started Free PRODUCT NAME: EDOXABAN, UN DE SES SELS, UN DE SES SOLVATES OU UN N-OXYDE DE CELUI-CI, EN PARTICULIER UN TOSYLATE D EDOXABAN. FIRST REGISTRATION: 20150619
1429780 13C0012 France ⤷  Get Started Free PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1405852 CR 2015 00052 Denmark ⤷  Get Started Free PRODUCT NAME: EDOXABAN, OR A SALT THEREOF, A SOLVATE THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Daiichi – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Daiichi Sankyo Co., Ltd., a notable player in the global pharmaceutical arena, has carved a distinct niche through innovation and strategic growth. With a history rooted in Japan, the company has expanded its footprint across North America, Europe, and emerging markets, leveraging a robust portfolio of oncology, cardiovascular, and immunology therapies. This analysis offers a comprehensive review of Daiichi’s current market position, core strengths, competitive environment, and strategic movements designed to fortify its global footprint.

Market Positioning

Daiichi Sankyo holds a competitive position as a mid-to-large pharmaceutical firm with annual revenues estimated at approximately $10 billion in 2022 [1]. Its strategic focus on oncology, especially targeted therapies for breast, lung, and gastric cancers, positions it prominently within high-growth segments. Notably, its blockbuster drug, Enhertu (trastuzumab deruxtecan), global sales exceeded $2.2 billion in 2022, underpinning its innovative prowess and market presence in antibody-drug conjugates (ADCs) [2].

While traditionally strong in Japan, Daiichi has expanded aggressively into North America, establishing significant R&D and commercial infrastructure. The company's presence in Europe remains concentrated, with ongoing collaborations to penetrate emerging markets across Asia, Latin America, and Africa. Overall, Daiichi competes alongside giants like Roche, Novartis, and Pfizer, differentiating itself through a robust pipeline and focus on targeted therapies.

Core Strengths

1. Robust R&D Pipeline and Innovation

Daiichi’s strategy centers on innovative drug development, notably in oncology and immunology. Its R&D expenditure exceeded 20% of revenues in 2022, evidencing a commitment to pipeline growth. The company’s focus on ADCs—a technologically advanced class of targeted therapies—has yielded significant assets like Enhertu. Such investments reinforce its position as a pioneer in precision medicine [3].

2. Strategic Collaborations and Licensing Agreements

Daiichi effectively leverages collaborations to enhance its portfolio. Its partnership with AstraZeneca for the development of cancer therapeutics exemplifies collaborative innovation, providing access to cutting-edge technologies and expanding its influence in immuno-oncology. The licensing and co-development deals enhance R&D productivity and share risks, allowing Daiichi to access novel compounds without bearing all costs upfront.

3. Geographic Diversification

While originating from Japan, Daiichi’s global strategic expansion limits regional vulnerabilities. The company maintains a strong foothold in Japan, complemented by growing market share in North America and Europe. Its presence in emerging markets leverages local partnerships and tailored product portfolios, fostering sustainable long-term growth.

4. Focused Product Portfolio on High-Growth Segments

By concentrating efforts on oncology, cardiovascular, and immunology therapeutics, Daiichi aligns itself with high-demand, high-margin sectors. The recent approval of new indications for Enhertu and the pipeline’s expansion into hematologic cancers underpin its targeted approach to specialty medicines.

5. Operational Efficiency and Cost Management

Daiichi’s integration of advanced manufacturing processes and digital transformation initiatives has improved operational efficiency. Cost containment coupled with strategic R&D investments enables rapid market entry and sustained innovation cycles.

Competitive Environment

Daiichi faces intense competition in each of its core segments:

  • Oncology: Competing with Roche's Herceptin, Novartis’s Kisqali, and AstraZeneca’s Tagrisso. Its ADC platform is a differentiation but must maintain a steady pipeline of successors to stay ahead.
  • Cardiovascular & Immunology: Competing with Pfizer’s Xeljanz and Novartis’s Cosentyx, Daiichi’s positioning relies on niche drugs and expanding indications.
  • Emerging Markets: Competition from local firms and generics providers requires strategic local partnerships and differentiated offerings.

Furthermore, patent cliffs, regulatory hurdles, and pricing pressures in mature markets challenge profitability. The company's ability to diversify its pipeline and capitalize on precision medicine trends remains critical to sustain its competitive edge.

Strategic Insights

1. Emphasize Next-Generation ADCs and Oncology Innovations

Building upon the success of Enhertu, Daiichi must continue R&D investments to develop next-generation ADCs with improved efficacy and safety profiles. Strategic acquisitions or licensing of promising candidates can reinforce its leadership in targeted cancer therapies.

2. Expand Global Commercial Footprint

To counteract intensifying competition, Daiichi should accelerate its market entry strategies into North American and European territories through local partnerships, regulatory approvals, and tailored commercialization strategies. Expanding manufacturing capacity can mitigate supply chain risks and enhance market responsiveness.

3. Harness Digital Transformation & Data Analytics

Investments in digital platforms, real-world evidence, and predictive analytics can optimize R&D, streamline clinical trials, and refine pharmacovigilance. Data-driven insights will support personalized medicine approaches, differentiating Daiichi’s offerings.

4. Pursue Strategic Mergers & Acquisitions

Acquiring or partnering with emerging biotech firms offers access to novel assets and innovative technologies, reducing time-to-market for breakthrough therapies. This strategy also mitigates the risks and costs associated with internal R&D.

5. Foster Patient-Centric and Sustainable Practices

Implementing patient-centric models and sustainability initiatives will enhance brand reputation and compliance resilience, aligning with evolving healthcare policies focused on affordability and environmental responsibility.

Conclusion

Daiichi Sankyo’s trajectory reflects a strategic balance of innovation, geographic diversification, and operational excellence. Its focus on high-growth segments, particularly in oncology, coupled with technological advancements, fortifies its competitive positioning. To sustain momentum, Daiichi must accelerate pipeline progression, expand into key markets, and leverage digital innovation—all while maintaining cost competitiveness and addressing regulatory challenges.

Key Takeaways

  • Daiichi’s strength in targeted oncology therapies, especially ADCs, positions it uniquely against regional and global competitors.
  • Strategic collaborations enhance R&D productivity, although independence in pipeline development remains vital.
  • Geographic diversification mitigates regional risks but requires tailored market strategies for sustainable growth.
  • Continuous innovation and digital integration are essential to remain at the forefront of precision medicine.
  • Mergers, acquisitions, and licensing are pivotal to expanding its pipeline efficiently amid competitive pressures.

FAQs

1. What are Daiichi Sankyo’s flagship products and therapeutic areas?
Daiichi’s flagship products include Enhertu for HER2-positive cancers, with primary focus on oncology. Its core therapeutic areas encompass oncology, cardiovascular diseases, and immunology.

2. How does Daiichi differentiate itself in the competitive oncology landscape?
Daiichi’s differentiation lies in its pioneering ADC technology, strategic partnerships, and tailored targeted therapies, enabling it to develop innovative cancer treatments with high specificity and efficacy.

3. What are the key growth regions for Daiichi Sankyo?
Primary growth regions include North America, Japan, and Europe, with emerging markets in Asia and Latin America presenting additional opportunities through localized partnerships.

4. How is Daiichi managing patent risks and product lifecycle challenges?
Daiichi invests heavily in R&D to develop next-generation therapies, while also seeking patent extensions and strategic collaborations to prolong market exclusivity.

5. What future strategic initiatives should Daiichi pursue?
Expanding its ADC pipeline, strengthening global commercialization, embracing digital health solutions, and pursuing strategic M&A are critical to fueling sustained growth.


Sources:
[1] Daiichi Sankyo Annual Report 2022
[2] Company Financials & Strategic Updates, 2022
[3] Industry Reports and Market Data, 2022

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