JANSSEN BIOTECH Company Profile

What is the competitive landscape for JANSSEN BIOTECH

JANSSEN BIOTECH has five approved drugs.

There are thirty-five US patents protecting JANSSEN BIOTECH drugs.

There are eight hundred and fifty-four patent family members on JANSSEN BIOTECH drugs in sixty-two countries and seventy-three supplementary protection certificates in twenty countries.

Summary for JANSSEN BIOTECH

International Patents:	854
US Patents:	35
Tradenames:	5
Ingredients:	5
NDAs:	5
Patent Litigation for JANSSEN BIOTECH:	See patent lawsuits for JANSSEN BIOTECH

Drugs and US Patents for JANSSEN BIOTECH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,207,311
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	10,898,482		Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	8,445,507		Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	9,987,261		Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	10,052,314				Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	9,388,159		Y	Y

Expired US Patents for JANSSEN BIOTECH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	5,604,213

Paragraph IV (Patent) Challenges for JANSSEN BIOTECH drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	250 mg		2015-04-28
	Tablets	500 mg		2017-08-23

International Patents for JANSSEN BIOTECH Drugs

Country	Patent Number	Estimated Expiration
Brazil	112021014969
Hungary	S1800022
Hungary	E048006
Japan	5989965
Japan	2020505425
Mexico	365702

Supplementary Protection Certificates for JANSSEN BIOTECH Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	132018000000301	Italy		PRODUCT NAME: NIRAPARIB TOSILATO O UN SUO IDRATO, IN PARTICOLARE IL TOSILATO MONOIDRATO(ZEJULA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1235, 20171120
2109608	300937	Netherlands		PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608	667	Finland
2109608	CA 2018 00017	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120
2109608	CR 2018 00017	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
3533792	PA2021525	Lithuania		PRODUCT NAME: APALUTAMIDAS; REGISTRATION NO/DATE: EU/1/18/1342 20190114

Similar Applicant Names

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

• Janssen Biotech
• Janssen Pharma
• Janssen Pharms
• Janssen Prods
• Janssen R And D
• Janssen Res And Dev

Pharmaceutical Competitive Landscape Analysis: Janssen Biotech – Market Position, Strengths & Strategic Insights

Introduction to Janssen Biotech

Janssen Biotech, a subsidiary of Johnson & Johnson, stands as a formidable player in the pharmaceutical industry. With a rich history of innovation and a strong commitment to research and development, Janssen has positioned itself as a leader in several key therapeutic areas. This article delves into Janssen's market position, strengths, and strategic insights, providing a comprehensive analysis of its competitive landscape.

Janssen's Market Position

Janssen Biotech has established itself as a major force in the pharmaceutical industry, consistently ranking among the top global pharmaceutical companies. The company's focus on six key therapeutic areas has allowed it to develop a strong market presence and a robust pipeline of innovative drugs.

Key Therapeutic Areas

Janssen concentrates its efforts on six primary therapeutic areas:

1. Cardiovascular and Metabolism
2. Immunology
3. Infectious Diseases and Vaccines
4. Neuroscience
5. Oncology
6. Pulmonary Hypertension

This focused approach has enabled Janssen to develop deep expertise in these areas and maintain a competitive edge in the market.

Market Share and Revenue

Janssen's pharmaceutical segment reported impressive revenue of more than $50 billion in fiscal 2021, with operational growth of 13.1%[4]. This strong financial performance underscores the company's solid market position and its ability to generate consistent growth.

"By periodically refocusing our portfolio, Janssen ensures that we are deeply invested in products that have the power to transform patients' lives," said Bill Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation and Medical Officer and Interim Head, Janssen R&D[3].

Janssen's Strengths and Competitive Advantages

Robust R&D Capabilities

One of Janssen's most significant strengths lies in its robust research and development capabilities. The company invested $11.9 billion in R&D in 2021, a 24% increase over the previous year[4]. This substantial investment in R&D drives innovation and keeps Janssen's product pipeline strong, ensuring a steady flow of new products and therapies to the market.

Diverse Product Portfolio

Janssen boasts a diverse product portfolio across its six therapeutic areas. This diversification reduces dependency on any single product or market segment, providing stability and multiple growth opportunities. Some of Janssen's key products include:

1. STELARA (ustekinumab): Accounted for approximately 10.2% of Johnson & Johnson's total revenues in 2022[6].
2. DARZALEX and DARZALEX FASPRO: Collectively accounted for about 8.4% of total revenues in 2022[6].

Strong Patent Protection

Janssen's intellectual property strategy ensures strong patent protection for its key products. For instance:

• STELARA's latest expiring U.S. composition of matter patent expires in 2023, while the European patent expires in 2024[6].
• DARZALEX's licensed patents expire in the U.S. in 2029 and in Europe in 2032[6].

This robust patent protection helps Janssen maintain market exclusivity for its innovative drugs, contributing to its competitive advantage.

Global Market Presence

Janssen's extensive global presence allows it to tap into various markets, reducing the impact of regional economic fluctuations and regulatory changes. This global footprint enables the company to leverage diverse growth opportunities and mitigate risks associated with market-specific challenges.

Strategic Insights and Future Outlook

Focus on Innovation and Pipeline Development

Janssen's strategy revolves around continuous innovation and pipeline development. The company's approach includes:

1. Investing heavily in R&D to drive innovation
2. Focusing on precision medicine and transformative therapies
3. Exploring new approaches to disease prevention and interception

Strategic Partnerships and Collaborations

Janssen recognizes the importance of external partnerships in driving innovation. The company has formed more than 400 alliances globally[1], collaborating with academic institutions, interest groups, and companies of all sizes. These partnerships aim to advance scientific research and deliver innovative solutions that provide value to patients, physicians, and healthcare systems worldwide.

Pathway-Based Approach

Janssen is implementing a pathway-based approach to drug development, which could help make it a $60 billion pharma company by 2025[4]. This approach involves:

1. Moving from immunosuppression to immune homeostasis
2. Expanding from about six anatomy-based diseases to more than 20 addressable diseases

Digital Health and Technology Integration

Janssen is increasingly integrating digital health solutions and advanced technologies into its research and development processes. This includes leveraging artificial intelligence, machine learning, and big data analytics to accelerate drug discovery and development.

Competitive Landscape

Key Competitors

Janssen faces competition from several major pharmaceutical companies, including:

1. Pfizer
2. Merck & Co.
3. Novartis AG
4. Roche
5. AstraZeneca

Competitive Strategies

To maintain its competitive edge, Janssen employs several strategies:

1. Continuous innovation through substantial R&D investments
2. Strategic acquisitions and partnerships to expand capabilities and pipeline
3. Focus on high-growth therapeutic areas
4. Leveraging its global presence for market expansion

Challenges and Opportunities

Challenges

1. Intense competition in key therapeutic areas
2. Regulatory hurdles and pricing pressures
3. Patent expirations of key products

Opportunities

1. Expanding presence in emerging markets
2. Leveraging technological advancements in drug discovery and development
3. Focusing on unmet medical needs in growing therapeutic areas

Future Outlook

Janssen's future outlook appears promising, driven by its strong R&D pipeline, strategic focus on key therapeutic areas, and commitment to innovation. The company's pathway-based approach and strategic partnerships position it well for continued growth and market leadership.

Key Takeaways

1. Janssen Biotech maintains a strong market position with a focus on six key therapeutic areas.
2. The company's robust R&D capabilities and substantial investments drive continuous innovation.
3. A diverse product portfolio and strong patent protection contribute to Janssen's competitive advantage.
4. Strategic partnerships and a pathway-based approach are key elements of Janssen's growth strategy.
5. Despite challenges, Janssen is well-positioned for future growth through innovation and market expansion.

FAQs

1. Q: What are Janssen Biotech's main therapeutic areas? A: Janssen focuses on six key therapeutic areas: Cardiovascular and Metabolism, Immunology, Infectious Diseases and Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

2. Q: How much does Janssen invest in R&D? A: In 2021, Janssen invested $11.9 billion in R&D, representing a 24% increase over the previous year.

3. Q: What is Janssen's pathway-based approach? A: The pathway-based approach involves moving from immunosuppression to immune homeostasis and expanding from about six anatomy-based diseases to more than 20 addressable diseases.

4. Q: Who are Janssen's main competitors? A: Janssen's main competitors include Pfizer, Merck & Co., Novartis AG, Roche, and AstraZeneca.

5. Q: What is Janssen's strategy for maintaining its competitive edge? A: Janssen maintains its competitive edge through continuous innovation, strategic partnerships, focus on high-growth therapeutic areas, and leveraging its global presence for market expansion.

Sources cited: [1] https://www.janssen.com/belgium/rd-janssen [2] https://www.fiercebiotech.com/sponsored/janssens-approach-business-development-and-strategic-partnerships [3] https://www.jnj.com/media-center/press-releases/janssen-provides-portfolio-update [4] https://www.drugdiscoverytrends.com/janssen-company-group-chairman-dishes-on-growth-strategy/ [6] https://s203.q4cdn.com/636242992/files/doc_financials/2022/ar/2022-annual-report.pdf