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Last Updated: December 15, 2025

Janssen Biotech Company Profile


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Summary for Janssen Biotech
International Patents:1118
US Patents:42
Tradenames:6
Ingredients:6
NDAs:6
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 BALVERSA erdafitinib TABLET;ORAL 212018-002 Apr 12, 2019 RX Yes No 9,464,071 ⤷  Get Started Free ⤷  Get Started Free
Janssen Biotech LAZCLUZE lazertinib mesylate TABLET;ORAL 219008-001 Aug 19, 2024 RX Yes No 11,453,656 ⤷  Get Started Free Y Y ⤷  Get Started Free
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes 9,388,159 ⤷  Get Started Free Y Y ⤷  Get Started Free
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No 12,383,543 ⤷  Get Started Free ⤷  Get Started Free
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No 11,091,459 ⤷  Get Started Free Y Y ⤷  Get Started Free
Janssen Biotech AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-002 Aug 11, 2023 RX Yes Yes 8,859,562 ⤷  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
Paragraph IV (Patent) Challenges for JANSSEN BIOTECH drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 500 mg ➤ Subscribe 2017-08-23
➤ Subscribe Tablets 250 mg ➤ Subscribe 2015-04-28

Supplementary Protection Certificates for Janssen Biotech Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3533792 CA 2021 00041 Denmark ⤷  Get Started Free PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2368550 C02368550/01 Switzerland ⤷  Get Started Free PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67072 19.09.2019
1633724 1590019-4 Sweden ⤷  Get Started Free PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
2368550 2019/032 Ireland ⤷  Get Started Free PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1342 20190114
1633724 S1500012 Hungary ⤷  Get Started Free PRODUCT NAME: OLAPARIB
3533792 43/2021 Austria ⤷  Get Started Free PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Last updated: October 15, 2025

Introduction

Janssen Biotech, a subsidiary of Johnson & Johnson, is a prominent player in the global pharmaceutical industry, renowned for its focus on innovative therapies spanning oncology, immunology, neuroscience, infectious diseases, and vaccines. As the pharmaceutical landscape becomes increasingly competitive due to rapid technological advances and evolving regulatory requirements, a comprehensive analysis of Janssen’s market position, core strengths, and strategic initiatives is crucial for stakeholders aiming to understand its future trajectory.

This report provides an in-depth review of Janssen Biotech's competitive standing within the pharmaceutical sector, analyzing its market share, innovation pipeline, strategic partnerships, and targeted therapeutic areas. The aim is to equip decision-makers with actionable insights into Janssen’s competitive advantages and potential growth avenues.


Janssen Biotech’s Market Position

Global Market Presence

Janssen Biotech holds a significant position within the global biopharmaceutical market, consistently ranking among the top pharmaceutical companies by revenue. According to Johnson & Johnson’s fiscal reports, Janssen contributed approximately 58% of the parent company's total pharmaceutical sales in 2022, underscoring its centrality [1].

Its footprint is especially pronounced in the United States, where it dominates several therapeutic segments. Europe and emerging markets also represent expanding territories, leveraging local manufacturing facilities and tailored marketing strategies to increase market penetration.

Therapeutic Area Leadership

Janssen’s core therapeutic areas include oncology, immunology, neuroscience, infectious diseases, and vaccines.

  • Oncology: Janssen’s portfolio encompasses blockbuster drugs like Imbruvica (ibrutinib) and Darzalex (daratumumab), positioning it as a leader in hematologic cancers.

  • Immunology: The company successfully markets Stelara (ustekinumab) and Simponi (golimumab), both pivotal in inflammatory bowel disease and rheumatoid conditions.

  • Infectious Diseases and Vaccines: Janssen’s COVID-19 vaccine, Johnson & Johnson’s Janssen COVID-19 Vaccine, boosted its profile globally, alongside other vaccines for Ebola and HPV.

Market Share and Competitive Rankings

Janssen consistently ranks among the top five global pharmaceutical companies by revenue, with notable dominance in immunology and oncology segments [2]. In 2022, its immunology segment captured approximately 25% market share globally, primarily driven by Stelara. Its oncology portfolio also secured substantial market shares owing to Imbruvica’s widespread adoption.


Strengths of Janssen Biotech

Robust R&D Pipeline and Innovation Focus

Janssen invests heavily in research and development, channeling approximately €6.5 billion annually into R&D activities [3]. It maintains a diversified pipeline with over 100 candidates across clinical and preclinical stages, targeting areas of high unmet medical need, including multiple myeloma, autoimmune disorders, and infectious diseases.

Its focus on biologics, advanced therapies, and precision medicine aligns with industry trends, enabling it to develop next-generation treatments with improved efficacy and safety profiles.

Strategic Collaborations and Acquisitions

Janssen’s strategic partnerships bolster its innovation capacity. Notable collaborations include alliances with biotech firms like Harpoon Therapeutics and convalescent plasma companies, facilitating access to novel technologies and expanding its pipeline.

Acquisitions, such as the acquisition of Momenta Pharmaceuticals in 2020, enhanced Janssen’s portfolio in autoimmune and inflammatory disease therapeutics, providing scalable antibody platform technologies [4].

Global Manufacturing and Supply Chain Strengths

Janssen’s diversified manufacturing footprint, including facilities across the US, Europe, and emerging markets, ensures robust supply chain resilience. Its capacity to rapidly scale production—for example, during the COVID-19 pandemic—demonstrates operational agility and reinforces its reputation as a reliable supply partner [5].

Regulatory Expertise and Commercial Capabilities

With a long track record of successful regulatory filings—over 100 FDA approvals—Janssen benefits from extensive regulatory expertise. Its commercial teams are adept at navigating complex markets, leveraging data-driven marketing and patient-centric approaches.


Strategic Insights and Opportunities

Emphasis on Personalized Medicine

Janssen’s focus on biomarker-driven therapies aligns with the industry shift toward personalized medicine. By integrating diagnostics with treatment options, the company aims to improve patient outcomes and foster premium pricing strategies.

Expanding Digital and Data Capabilities

Investments in digital health initiatives and real-world evidence (RWE) platforms can enhance clinical trial efficiency and post-market surveillance. Janssen’s partnerships with digital health startups reflect a strategic move to innovate its R&D and commercial strategies.

Sustainability and Access Initiatives

Addressing global access and affordability challenges enhances brand reputation. Janssen’s engagement in programs like the Janssen COVID-19 vaccine distribution showcases its commitment to health equity, potentially providing a competitive advantage in emerging markets.

Pipeline Diversification and Next-Generation Therapies

Continuous innovation in cell and gene therapies, antibody-drug conjugates (ADCs), and bispecific antibodies presents future growth pathways. Focused investment in these high-value areas could position Janssen at the forefront of next-gen therapeutics.

Competitive Risks

  • Patent Expirations: Key products face patent cliffs in the coming years, risking revenue erosion unless offset by pipeline success.
  • Market Competition: Competitors such as Novartis, Roche, and Merck are aggressively advancing similar therapies, emphasizing the importance of sustained innovation.
  • Regulatory and Pricing Pressures: Increasing scrutiny by regulators and payers worldwide necessitate strategic pricing and value demonstration.

Conclusion

Janssen Biotech solidifies its leadership through a diversified portfolio, substantial R&D investment, and strategic partnerships. Its strong market share in oncology and immunology affirms its innovative edge, while supply chain resilience and regulatory expertise underpin its operational strength.

To sustain growth, Janssen must leverage emerging technologies, embrace personalized medicine, and proactively address market challenges posed by patent cliffs and global competition. Its strategic focus on innovation and access positions it favorably in an evolving pharmaceutical landscape, though vigilance is essential to navigate mounting pressures.


Key Takeaways

  • Janssen maintains a dominant global position, especially in oncology and immunology, supported by high-impact products like Imbruvica and Stelara.
  • Heavy investment in R&D ensures a rich pipeline of next-generation therapies, vital for future growth amid patent expirations.
  • Strategic collaborations expand innovation capacity and market reach, while operational agility enhances supply chain resilience.
  • Embracing digital health, personalized medicine, and access initiatives will be essential to sustain competitive advantage.
  • Vigilance against patent cliffs and intensified global competition necessitates continuous innovation and strategic agility.

FAQs

1. How does Janssen's pipeline compare to its competitors?
Janssen maintains a robust and diversified pipeline with over 100 candidates, focusing on biologics and precision medicine. Its strategic investment in cell and gene therapies often surpasses many competitors, positioning it as a leader in next-generation therapeutics.

2. What are the biggest risks facing Janssen’s market position?
Patent expirations for flagship products, intensifying competition in core segments, and regulatory pricing pressures globally pose significant risks. Swift pipeline advancement and innovation are critical to mitigating these challenges.

3. How does Janssen’s global strategy address emerging markets?
Janssen leverages localized manufacturing and tailored marketing strategies to expand presence in emerging markets, supported by affordable pricing programs and collaborations to improve healthcare access.

4. What role does digital health play in Janssen’s future plans?
Digital health investments aim to enhance clinical development, real-world evidence collection, and patient engagement, thus improving therapeutic outcomes and operational efficiencies.

5. How is Janssen positioning itself in personalized medicine?
Janssen integrates biomarkers and diagnostics into its therapeutic development, focusing on targeted treatments that offer personalized patient approaches, thereby aligning with industry trends toward precision medicine.


References

[1] Johnson & Johnson Annual Report 2022.
[2] IQVIA Market Reports, 2022.
[3] Janssen R&D Investment Announcement, 2022.
[4] Johnson & Johnson Acquisition Press Release, 2020.
[5] FDA and EMA Regulatory Updates, 2022.

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