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Last Updated: March 19, 2026

Janssen Biotech Company Profile


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Summary for Janssen Biotech
International Patents:1124
US Patents:44
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 LAZCLUZE lazertinib mesylate TABLET;ORAL 219008-002 Aug 19, 2024 RX Yes Yes 11,453,656 ⤷  Get Started Free Y Y ⤷  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 AKEEGA abiraterone acetate; niraparib tosylate TABLET;ORAL 216793-001 Aug 11, 2023 RX Yes No 8,859,562 ⤷  Get Started Free ⤷  Get Started Free
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes 12,303,493 ⤷  Get Started Free Y ⤷  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
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 2015/016 Ireland ⤷  Get Started Free PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2368550 C201930040 Spain ⤷  Get Started Free PRODUCT NAME: APALUTAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
2109608 PA2018009 Lithuania ⤷  Get Started Free PRODUCT NAME: NIRAPAARIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA, STEREOIZOMERAS ARBA TAUTOMERAS, BUTENT TOSILATAS ARBA HIDRATAS, YPATINGAI TOSILATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1235 20171116
>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.

Janssen Biotech: Market Position, Strengths & Strategic Insights

Last updated: February 20, 2026

What is Janssen Biotech’s current market position?

Janssen Biotech, a division of Johnson & Johnson, ranks among the leading biopharmaceutical companies globally. It specializes in Oncology, Immunology, Neuroscience, Infectious Diseases, and Pulmonary disorders. As of 2023, Janssen holds approximately 4.5% of the global biotech sales, estimated at over $340 billion (IQVIA, 2023). Its presence spans more than 100 countries, with especially strong footholds in North America, Europe, and select Asian markets.

Janssen’s revenue was approximately $49 billion in 2022, up 10% year-over-year, with Oncology drugs contributing roughly 40% of total sales. The company ranks fourth among global immunology firms, behind AbbVie, Roche, and Novartis (EvaluatePharma, 2023).

What are Janssen’s key strengths?

Robust Product Portfolio

Janssen maintains an extensive portfolio with 40+ approved medicines. Key products include:

  • Repatha (evolocumab): LDL cholesterol-lowering PCSK9 inhibitor, over $3.5 billion in annual sales.
  • Imbruvica (ibrutinib): Hematologic cancer treatment, generating approximately $4 billion annually.
  • Darzalex (daratumumab): Multiple myeloma therapy, with sales exceeding $2.8 billion in 2022.

Pipeline and R&D Investment

The division invests over $4 billion annually in R&D. Its pipeline includes over 80 therapies targeting oncology, immunology, and neuroscience, with 20+ in late-stage development. Notably, Janssen is advancing CAR-T therapies and antibody-drug conjugates, indicating focus on innovative immunotherapies.

Strategic Collaborations and Acquisitions

Janssen has a history of acquiring promising biotech firms and entering strategic alliances. Recent acquisitions include Celltrion’s biosimilar assets and control of BeiGene’s global oncology pipeline. Collaborations with Genmab and Centessa Pharmaceuticals expand its immunology and rare disease portfolio.

Manufacturing Capacity and Supply Chain

Janssen operates 13 manufacturing plants globally, ensuring supply security. Its vertical integration supports rapid scale-up for novel therapies. The company also maintains active quality control systems to meet FDA, EMA, and other regulatory standards.

What strategic insights can be derived from Janssen's approach?

Focused Therapeutic Expansion

Janssen emphasizes high-growth areas like oncology and immunology. It prioritizes products with strong market penetration and potential for lifecycle management, such as combination therapies and biosimilars.

Diversified R&D Pipeline

The company emphasizes early-to-late stage assets, aiming for breakthrough therapies. Its pipeline strategy balances high-risk, high-reward innovations with incremental improvements on existing medicines.

Geographic Penetration Strategy

Janssen targets emerging markets for future growth, tailoring regulatory strategies and pricing models to local conditions. These efforts aim to offset saturation in mature markets.

Digital and Data-Driven Innovation

Janssen invests in digital health, real-world evidence, and personalized medicine platforms. This supports accelerated clinical trials and targeted marketing. AI and machine learning are integrated into drug discovery and development processes, driving efficiencies.

Resilience through Diversification

The combination of diversified product categories and broad geographic reach enhances resilience against market fluctuations or patent expirations. It also buffers the impact of regulatory changes in specific regions.

How do Janssen’s strengths compare to competitors?

Feature Janssen AbbVie Roche Novartis
Total Revenue (2022) $49 billion $58 billion $61 billion $51 billion
Key Oncology Product Darzalex Imbruvica Avastin, Hemlibra Kisqali, Tagrisso
R&D Investment $4+ billion $4+ billion $6+ billion $9+ billion
Pipeline Strength 80+ therapies, focus on CAR-T Focus on immunology, oncology Precision medicine Gene therapy, immunology
Geographic Reach 100+ countries 180+ countries 150+ countries 155+ countries

Janssen’s strengths lie in its diversified portfolio, active pipeline, and global manufacturing capacity. However, competitors such as Roche and Novartis have larger R&D budgets and broader geographic footprints.

What are potential strategic risks and opportunities?

Risks

  • Patent expirations in key blocks, like Imbruvica (2026), threaten revenue streams.
  • High R&D costs versus uncertain approval success.
  • Regulatory challenges and pricing pressures in emerging markets.

Opportunities

  • Growth in biosimilars, especially in immunology and oncology.
  • Expansion into emerging markets with tailored pricing models.
  • Advancing personalized medicine through digital health integration.

Key Takeaways

  • Janssen is a major player with a focus on oncology and immunology.
  • It maintains a selective but robust R&D pipeline with a strong emphasis on innovative therapies.
  • Global manufacturing and strategic acquisitions underpin its growth strategy.
  • Competition remains intense, especially from Roche and Novartis, with larger R&D budgets and broader pipelines.
  • Future growth hinges on pipeline success, market expansion, and digital health adoption.

FAQs

1. How does Janssen’s pipeline compare to competitors?
It has over 80 therapies in development, focusing on immuno-oncology and biologics, but rivals like Roche and Novartis invest more heavily in gene therapies and personalized medicine.

2. What are the primary growth drivers for Janssen in 2023?
Key drivers include sales of existing oncology and immunology drugs, pipeline approvals, and expansion into emerging markets with biosimilars and innovative therapies.

3. How does Janssen address patent expirations?
By developing next-generation therapies, biosimilars, and expanding its pipeline into new therapeutic areas. Strategic acquisitions also counter patent loss impacts.

4. What role does digital health play in Janssen’s strategy?
Digital health underpins clinical trials efficiency, real-world evidence collection, and personalized treatment approaches, supporting faster drug development and market penetration.

5. What are Janssen’s main risks in maintaining its market position?
Patent cliffs, regulatory hurdles, high R&D costs, and market access challenges in emerging markets.

References

[1] IQVIA. (2023). Global biotech sales data.
[2] EvaluatePharma. (2023). Top 20 pharmaceutical companies by revenue.

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