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Last Updated: December 18, 2025

Takeda Pharms Usa Company Profile


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Summary for Takeda Pharms Usa
International Patents:1288
US Patents:98
Tradenames:43
Ingredients:33
NDAs:40

Drugs and US Patents for Takeda Pharms Usa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa EXKIVITY mobocertinib succinate CAPSULE;ORAL 215310-001 Sep 15, 2021 DISCN Yes No 10,227,342 ⤷  Get Started Free Y Y ⤷  Get Started Free
Takeda Pharms Usa TRINTELLIX vortioxetine hydrobromide TABLET;ORAL 204447-002 Sep 30, 2013 RX Yes No 7,144,884*PED ⤷  Get Started Free Y ⤷  Get Started Free
Takeda Pharms Usa EOHILIA budesonide SUSPENSION;ORAL 213976-001 Feb 9, 2024 RX Yes Yes 9,050,368 ⤷  Get Started Free Y ⤷  Get Started Free
Takeda Pharms Usa PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Takeda Pharms Usa FOSRENOL lanthanum carbonate TABLET, CHEWABLE;ORAL 021468-003 Nov 23, 2005 AB RX Yes No ⤷  Get Started Free ⤷  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

Expired US Patents for Takeda Pharms Usa

Paragraph IV (Patent) Challenges for TAKEDA PHARMS USA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 15 mg/500 mg and 15 mg/850 mg ➤ Subscribe 2008-03-06
➤ Subscribe Delayed-release Pellets/Capsul 15 mg and 30 mg ➤ Subscribe 2005-12-05
➤ Subscribe Tablets 30 mg/2 mg and 30 mg/4 mg ➤ Subscribe 2009-12-22
➤ Subscribe Capsule 60 mg ➤ Subscribe 2010-08-25
➤ Subscribe Tablets 6.25 mg, 12.5 mg and 25 mg ➤ Subscribe 2017-01-25
➤ Subscribe Extended-release Capsules 100 mg and 200 mg ➤ Subscribe 2006-02-02
➤ Subscribe Tablets 5 mg, 10 mg, 15 mgand 20 mg ➤ Subscribe 2017-10-02
➤ Subscribe Extended-release Capsules 12.5 mg and 25 mg ➤ Subscribe 2017-08-07
➤ Subscribe For Injection 3.5 mg/vial ➤ Subscribe 2008-11-20
➤ Subscribe Chewable Tablet 500 mg, 750 mg and 1000 mg ➤ Subscribe 2008-10-27
➤ Subscribe Delayed-release Tablets 1.2 g ➤ Subscribe 2009-12-16
➤ Subscribe Extended-release Tablets 1 mg, 2 mg, 3 mg and 4 mg ➤ Subscribe 2009-12-29
➤ Subscribe Tablets 0.6 mg ➤ Subscribe 2011-12-23
➤ Subscribe Delayed-release Orally Disinte 15 mg and 30 mg ➤ Subscribe 2006-12-27
➤ Subscribe Tablets 12.5 mg/500 mg and 12.5 mg/1000 mg ➤ Subscribe 2017-01-25
➤ Subscribe Delayed-release Capsule 30 mg ➤ Subscribe 2010-11-30
➤ Subscribe Tablets 8 mg ➤ Subscribe 2009-07-22
➤ Subscribe Extended-release Capsules 37.5 mg and50 mg ➤ Subscribe 2017-08-03
➤ Subscribe Tablets 40 mg and 80 mg ➤ Subscribe 2013-02-13
➤ Subscribe Capsules 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg ➤ Subscribe 2011-02-23
➤ Subscribe Injection 10 mg/mL ➤ Subscribe 2015-08-25
➤ Subscribe Oral Powder 750 mg and 1000 mg ➤ Subscribe 2015-11-25
➤ Subscribe Extended-release Tablets 15 mg/1000 mg and 30 mg/1000 mg ➤ Subscribe 2011-09-23

Supplementary Protection Certificates for Takeda Pharms Usa Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 PA2012022 Lithuania ⤷  Get Started Free PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2178888 275 50004-2017 Slovakia ⤷  Get Started Free PRODUCT NAME: IXAZOMIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1094 20161123
1973545 13C0069 France ⤷  Get Started Free PRODUCT NAME: PONATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, SOLVATE OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545 72/2013 Austria ⤷  Get Started Free PRODUCT NAME: PONATINIB; REGISTRATION NO/DATE: EU/1/13/839 20130701
2498758 LUC00152 Luxembourg ⤷  Get Started Free PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: TAKEDA PHARMS USA – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025

Introduction

Takeda Pharmaceuticals USA Inc. stands as a pivotal player within the US pharmaceutical industry, consistently shaping the landscape through innovative product offerings, strategic acquisitions, and a focus on specialty medicine. This analysis explores Takeda’s market position, core strengths, and strategic directions, providing critical insights for stakeholders seeking to understand its competitive stance.


Market Positioning of Takeda Pharmaceuticals USA

Takeda maintains a prominent foothold within the US pharmaceutical sector, primarily targeting specialties such as oncology, rare diseases, neuroscience, and gastrointestinal disorders. As of 2023, the company's revenue in the US exceeds $6 billion, reflecting its robust commercial footprint [1].

The firm’s strategic focus is evident in its core portfolio, including blockbuster products like Entyvio (vedolizumab) for inflammatory bowel disease and Ninlaro (ixazomib) for multiple myeloma. Takeda's commitment to rare and orphan diseases reinforces its competitive edge, aligning with the growing demand for specialized therapies.

Furthermore, Takeda is leveraging its ongoing acquisitions—most notably the 2019 purchase of Shire—expanding its pipeline and market reach. The Shire integration bolstered Takeda’s presence in rare diseases and biologics, positioning it as a top 10 US pharmaceutical company by revenue [2].


Strengths Driving Takeda’s Competitiveness

1. Focused Portfolio on Specialty and Rare Diseases

Takeda’s emphasis on high-margin, specialty, and orphan drugs distinguishes it from peers heavily reliant on blockbuster blockbusters. This strategic concentration enhances revenue stability amid patent cliffs affecting traditional pharmaceuticals.

2. Robust R&D Pipeline

Investments exceeding $2 billion annually in R&D underpin Takeda’s pipeline, with approximately 60 clinical-stage assets spanning oncology, neuroscience, and rare diseases [3]. The company’s ability to bring innovative therapies to market positions it as a leader in niche therapeutic areas.

3. Strategic Acquisitions and Partnerships

The acquisition of Shire provided Takeda access to a broad portfolio of rare disease treatments, immunology, and hematology products. Additionally, collaborations with biotech firms and academic institutions amplify its innovation capacity and accelerate development timelines.

4. Strong Commercial Infrastructure

Takeda’s established commercial network, extensive distribution channels, and patient-centric marketing strategies enable it to effectively reach healthcare providers and patients, especially in specialized therapeutic areas.

5. Focused Global Expansion and Localized Strategies

While US-market dominance is vital, Takeda extends its footprint through targeted international expansion, harnessing localized strategies that adapt to regional healthcare landscapes. Its US operations benefit from this global synergy.


Strategic Insights and Future Outlook

a. Emphasis on Biologics and Gene Therapies

Takeda’s ongoing investment in biologics and gene therapies aligns with industry trends favoring personalized medicine. The company’s collaborations with biotech startups involve cutting-edge modalities like CAR-T cells and antisense technologies, signaling potential pipeline breakthroughs.

b. Digital Health and Real-World Evidence Integration

Harnessing digital health tools and real-world evidence (RWE) can optimize clinical outcomes and support marketing strategies. Takeda’s active engagement in digital initiatives forecasts a competitive advantage in pharmacovigilance and patient engagement.

c. Navigating Patent and Regulatory Challenges

Patent expirations pose risks; however, Takeda’s diversified portfolio and focus on biologics provide some insulation against generic competition. Continuous engagement with regulatory agencies ensures smooth approval pathways for innovative products.

d. Emphasizing Access and Value-Based Care

With increasing pressure to demonstrate value, Takeda aligns its offerings with payers through value-based contracts, ensuring affordability and sustained access, particularly for premium-priced therapies.

e. Commitment to Sustainability and Corporate Responsibility

Investor and consumer preferences favor companies with strong sustainability practices. Takeda’s commitments towards environmental, social, and governance (ESG) initiatives bolster its corporate reputation and stakeholder trust.


Conclusion

Takeda Pharmaceuticals USA’s strategic focus on specialty and rare disease therapeutics, supported by a solid pipeline, targeted acquisitions, and an adaptive commercial strategy, secures its position as a formidable player in the US pharmaceutical arena. By embracing biologics, digital health, and value-based models, Takeda is well-prepared to navigate emerging industry challenges and sustain growth.


Key Takeaways

  • Market Leadership: Takeda’s strategic emphasis on specialty and rare disease markets underpins its core competitive advantage.
  • Innovative Pipeline: Robust R&D investments and acquisitions like Shire position Takeda at the forefront of novel therapy development.
  • Growth Opportunities: Expanding biologics and gene therapies, coupled with digital health integration, offer significant growth avenues.
  • Risk Management: Diversified portfolio and focus on biologics mitigate patent expiry risks while regulatory engagement supports sustained product approvals.
  • Sustainability Focus: Prioritizing ESG initiatives enhances corporate reputation and stakeholder confidence.

FAQs

1. How does Takeda’s focus on rare diseases influence its market strategy?
Takeda’s concentration on rare diseases allows it to capitalize on high-margin, specialized treatments with less generic competition, fostering loyalty among niche patient populations and healthcare providers.

2. What role does M&A activity play in Takeda’s growth?
Acquisitions like Shire enable Takeda to diversify its portfolio, access new therapeutic areas, and expand its global footprint, serving as a key driver of revenue growth and innovation.

3. Is Takeda’s investment in biologics a strategic response to industry trends?
Yes. The growing demand for personalized medicine and complex biologics positions Takeda to leverage its competencies for superior market penetration and sustainable revenue streams.

4. How does Takeda address the challenges posed by patent expirations?
Takeda mitigates patent risks through diversification into biosimilars, biologics, and pipeline expansion, ensuring continued revenue streams beyond patent cliffs.

5. What are Takeda’s prospects in digital health innovation?
Takeda’s integration of digital tools enhances patient engagement, improves clinical trial efficiency, and supports pharmacovigilance, positioning it favorably within digital transformation trends.


References

[1] Takeda Pharmaceuticals US Annual Report, 2022.
[2] IQVIA Data, 2023.
[3] Takeda R&D Overview, 2023.

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