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Last Updated: April 5, 2025

ASTELLAS Company Profile


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Summary for ASTELLAS
International Patents:451
US Patents:32
Tradenames:21
Ingredients:16
NDAs:37
Patent Litigation for ASTELLAS: See patent lawsuits for ASTELLAS

Drugs and US Patents for ASTELLAS

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Astellas AMBISOME amphotericin b INJECTABLE, LIPOSOMAL;INJECTION 050740-001 Aug 11, 1997 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Astellas IZERVAY avacincaptad pegol sodium SOLUTION;INTRAVITREAL 217225-001 Aug 4, 2023 RX Yes Yes 7,579,456 ⤷  Try for Free Y ⤷  Try for Free
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 AP RX Yes Yes 8,106,183 ⤷  Try for Free Y ⤷  Try for Free
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-002 Apr 8, 1994 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 AP RX Yes Yes ⤷  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
Showing 1 to 5 of 5 entries

Expired US Patents for ASTELLAS

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Astellas CYCLOCORT amcinonide OINTMENT;TOPICAL 018498-001 Approved Prior to Jan 1, 1982 4,158,055 ⤷  Try for Free
Astellas IZERVAY avacincaptad pegol sodium SOLUTION;INTRAVITREAL 217225-001 Aug 4, 2023 7,803,931 ⤷  Try for Free
Astellas IZERVAY avacincaptad pegol sodium SOLUTION;INTRAVITREAL 217225-001 Aug 4, 2023 7,538,211 ⤷  Try for Free
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 8,470,801 ⤷  Try for Free
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 8,183,226 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for ASTELLAS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 3 mg/mL, 20 mL and 30 mL vials ➤ Subscribe 2005-04-18
➤ Subscribe Injection 0.08 mg/mL, 5 mL vial ➤ Subscribe 2012-04-10
➤ Subscribe Extended-release Capsules 0.5 mg, 1 mg, and 5 mg ➤ Subscribe 2013-11-15
➤ Subscribe For Injection 50 mg/vial and 100 mg/vial ➤ Subscribe 2014-06-16
➤ Subscribe Injection 3 mg/mL, 20 mL and 30 mL vials ➤ Subscribe 2005-04-16
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2009-04-08
➤ Subscribe Capsules 40 mg ➤ Subscribe 2016-08-31

Supplementary Protection Certificates for ASTELLAS Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1280795 1690011-0 Sweden ⤷  Try for Free PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
2948455 C02948455/01 Switzerland ⤷  Try for Free PRODUCT NAME: FEZOLINETANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69232 04.12.2023
2948455 C20240017 00433 Estonia ⤷  Try for Free PRODUCT NAME: FEZOLINETANT;REG NO/DATE: EU/1/23/1771 12.12.2023
1189916 C300477 Netherlands ⤷  Try for Free PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1280795 SPC/GB15/078 United Kingdom ⤷  Try for Free PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS AN ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTERED: UK EU/1/15/1036 20151019
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Astellas Pharma: A Comprehensive Analysis of Market Position, Strengths, and Strategic Insights

In the ever-evolving pharmaceutical landscape, Astellas Pharma has emerged as a formidable player, carving out a significant niche for itself. This Japanese multinational pharmaceutical company, formed in 2005 through the merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical, has since become a global leader in several therapeutic areas. Let's delve into Astellas' market position, strengths, and strategic insights to understand what sets this company apart in the competitive pharmaceutical industry.

Company Overview

Astellas Pharma Inc. is a top 25 global pharmaceutical research company headquartered in Tokyo, Japan[3]. The company's primary focus lies in developing innovative medical solutions in areas with high unmet medical needs, including urology, oncology, immunology, nephrology, and neuroscience[1].

Market Position

Global Presence

Astellas has established a strong global presence, operating in the Americas, Australia, Europe, Asia, and Oceania through a network of subsidiaries and affiliates[1]. This widespread geographical footprint allows the company to tap into diverse markets and leverage regional opportunities.

Revenue Distribution

In the fiscal year 2023, Astellas' sales revenue in the United States amounted to over 663 billion Japanese yen, making America the largest market for the company[2]. This underscores the importance of the U.S. market in Astellas' overall business strategy.

"In the fiscal year 2023, the sales revenue of Astellas Pharma Inc. in the United States amounted to over 663 billion Japanese yen, making America the largest market of the company."[2]

Therapeutic Areas

Astellas has strategically positioned itself in several key therapeutic areas:

  1. Urology
  2. Oncology
  3. Immunology
  4. Nephrology
  5. Neuroscience

This focused approach allows the company to concentrate its resources on areas where it can make the most significant impact and maintain a competitive edge.

Strengths and Core Capabilities

Research and Development

Astellas places a strong emphasis on R&D, striving to develop new drugs that address high unmet medical needs[1]. The company's pipeline includes promising drug candidates for various conditions, including:

  • Urothelial cancer
  • Gastric cancer
  • Gastroesophageal junction cancer
  • Anemia associated with chronic kidney disease
  • Acute myeloid leukemia

Innovative Approach

Astellas has adopted a Focus Area approach in its R&D strategy, allowing it to respond flexibly to rapid advances in science and changes in disease perception and treatment[7]. This approach enables the company to create innovative products that can potentially transform the underlying causes of diseases.

Strategic Partnerships

Astellas recognizes the value of collaboration and actively seeks partnerships to enhance its capabilities. For instance, the company expanded its collaboration with Cytokinetics in 2014, focusing on the R&D and commercialization of skeletal muscle activators[6].

Digital Transformation

Astellas has embraced digital transformation to enhance its operational efficiency. In collaboration with PwC and Microsoft Azure, the company unified its data systems and automated research performance, enabling more effective clinical trials and R&D[4].

Strategic Insights

Focus on Unmet Medical Needs

Astellas' strategy revolves around addressing high unmet medical needs. This focus not only drives innovation but also positions the company in potentially lucrative market segments with less competition.

Expansion through Acquisitions

Astellas has pursued a strategy of growth through strategic acquisitions. Notable acquisitions include:

  • OSI Pharmaceuticals (2010) for $4.0 billion
  • Ocata Therapeutics (2016) for $379 million
  • Ganymed Pharmaceuticals (2016) for $1.4 billion
  • Audentes Therapeutics (2019) for approximately $3 billion
  • Iveric Bio (2023) for $5.9 billion

These acquisitions have allowed Astellas to expand its pipeline, enter new therapeutic areas, and acquire cutting-edge technologies.

Commitment to Sustainability

Astellas has demonstrated a commitment to sustainability by setting ambitious environmental goals. The company achieved its existing goals in 2022 and established new, more ambitious goals in 2023[7].

Patient-Centric Approach

Astellas emphasizes a patient-centric approach in its drug development process. The Medical Intelligence and Patient Insights (MIPI) team partners with Astellas colleagues to analyze potential opportunities in targeted disease areas, placing particular emphasis on the patient and healthcare provider perspective[9].

Competitive Landscape

In the highly competitive pharmaceutical industry, Astellas faces competition from both global pharmaceutical giants and smaller, specialized biotech companies. However, the company's focused approach, strong R&D pipeline, and strategic acquisitions have helped it maintain a competitive edge in its core therapeutic areas.

Future Outlook

Astellas' future looks promising, with several factors contributing to its potential growth:

  1. Robust Pipeline: The company's strong R&D pipeline, particularly in oncology and urology, positions it well for future growth.

  2. Digital Transformation: Continued investment in digital technologies is likely to enhance operational efficiency and accelerate drug development.

  3. Strategic Acquisitions: Astellas' track record of successful acquisitions suggests that it will continue to use this strategy to expand its capabilities and market presence.

  4. Focus on Innovative Therapies: The company's commitment to developing transformative therapies, including cell and gene therapies, aligns well with the future direction of the pharmaceutical industry.

  5. Global Expansion: With a strong presence in major markets like the U.S. and Japan, Astellas is well-positioned to expand further into emerging markets.

Key Takeaways

  • Astellas Pharma is a top 25 global pharmaceutical company with a strong focus on urology, oncology, immunology, nephrology, and neuroscience.
  • The company's largest market is the United States, generating over 663 billion Japanese yen in sales revenue in fiscal year 2023.
  • Astellas' strengths lie in its robust R&D pipeline, innovative approach to drug development, strategic partnerships, and digital transformation initiatives.
  • The company's strategy revolves around addressing unmet medical needs, expanding through strategic acquisitions, and maintaining a patient-centric approach.
  • Astellas' future outlook is promising, driven by its strong pipeline, digital transformation efforts, and focus on innovative therapies.

FAQs

  1. Q: What are Astellas Pharma's main therapeutic areas? A: Astellas Pharma focuses primarily on urology, oncology, immunology, nephrology, and neuroscience.

  2. Q: How has Astellas Pharma grown through acquisitions? A: Astellas has made several significant acquisitions, including OSI Pharmaceuticals, Ocata Therapeutics, Ganymed Pharmaceuticals, Audentes Therapeutics, and most recently, Iveric Bio.

  3. Q: What is Astellas Pharma's approach to R&D? A: Astellas adopts a Focus Area approach in its R&D strategy, allowing it to respond flexibly to scientific advances and changes in disease perception and treatment.

  4. Q: How is Astellas Pharma incorporating digital transformation? A: Astellas has partnered with PwC and Microsoft Azure to unify its data systems and automate research performance, enhancing its clinical trials and R&D processes.

  5. Q: What sets Astellas Pharma apart from its competitors? A: Astellas distinguishes itself through its focused therapeutic approach, strong R&D pipeline, strategic acquisitions, and commitment to addressing high unmet medical needs.

Sources cited: [1] https://www.globaldata.com/company-profile/astellas-pharma-inc/ [2] https://www.statista.com/statistics/825709/astellas-pharma-sales-by-region/ [3] https://www.theworldfolio.com/company/astellas-pharma-inc/1583/ [4] https://www.pwc.com/us/en/library/case-studies/astellas-pharma-automated-data-processing.html [6] https://en.wikipedia.org/wiki/Astellas_Pharma [7] https://www.astellas.com/en/system/files/c3d87805b5/astellas_ar2023_e_all_1006.pdf [9] https://www.astellas.com/us/patient-focus/medical-intelligence-and-patient-insights

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