ASTELLAS Company Profile

What is the competitive landscape for ASTELLAS

ASTELLAS has thirty-seven approved drugs.

There are thirty-one US patents protecting ASTELLAS drugs. There is one tentative approval on ASTELLAS drugs.

There are four hundred and forty-four patent family members on ASTELLAS drugs in forty-three countries and seventy-four supplementary protection certificates in nineteen countries.

Summary for ASTELLAS

International Patents:	444
US Patents:	31
Tradenames:	21
Ingredients:	16
NDAs:	37
Patent Litigation for ASTELLAS:	See patent lawsuits for ASTELLAS

Drugs and US Patents for ASTELLAS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	10,206,879*PED				Y
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	12,016,875
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	7,579,456			Y
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	9,617,546			Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes

Expired US Patents for ASTELLAS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	5,376,634
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,144,872
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015	7,459,561
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	8,551,522
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	8,551,522
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,884,433
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,183,264

Paragraph IV (Patent) Challenges for ASTELLAS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Capsules	0.5 mg, 1 mg, and 5 mg		2013-11-15
	For Injection	50 mg/vial and 100 mg/vial		2014-06-16
	Injection	3 mg/mL, 20 mL and 30 mL vials		2005-04-16
	Tablets	5 mg and 10 mg		2009-04-08
	Capsules	40 mg		2016-08-31
	Injection	3 mg/mL, 20 mL and 30 mL vials		2005-04-18
	Injection	0.08 mg/mL, 5 mL vial		2012-04-10

International Patents for ASTELLAS Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	2860251
European Patent Office	2439196
European Patent Office	4324527
Denmark	3009428
Brazil	0015254
World Intellectual Property Organization (WIPO)	2011145642
Taiwan	I484961

Supplementary Protection Certificates for ASTELLAS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1189916	SZ 2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1280795	CA 2016 00002	Denmark		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; REG. NO/DATE: EU/1/15/1036 20151019
1280795	122016000011	Germany		PRODUCT NAME: ISAVUCONAZONIUM ALS ISAVUCONAZONIUM-SULFAT ODER ALS SALZ MIT EINEM ANDEREN PHARMAZEUTISCH VERTRAEGLICHEN ANION, SOWIE HYDRATE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/15/1036 20151015
2428508	122020000004	Germany		PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 20191024
1893196	C 2013 041	Romania		PRODUCT NAME: ENZALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/846; DATE OF NATIONAL AUTHORISATION: 20130621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/846; DATE OF FIRST AUTHORISATION IN EEA: 20130621
1189916	2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Astellas

ASTELLAS Market Analysis and Financial Projection

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