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Last Updated: December 19, 2025

Janssen Pharms Company Profile


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Summary for Janssen Pharms
International Patents:592
US Patents:22
Tradenames:56
Ingredients:34
NDAs:57

Drugs and US Patents for Janssen Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-005 Dec 23, 2004 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Janssen Pharms INVOKAMET XR canagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205879-002 Sep 20, 2016 RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 AB RX Yes No ⤷  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

Expired US Patents for Janssen Pharms

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 6,124,355*PED ⤷  Get Started Free
Janssen Pharms RAZADYNE galantamine hydrobromide TABLET;ORAL 021169-002 Feb 28, 2001 6,358,527 ⤷  Get Started Free
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 5,965,168*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for JANSSEN PHARMS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Oral Solution 25 mg/mL ➤ Subscribe 2009-07-30
➤ Subscribe Orally Disintegrating Tablets 0.25 mg ➤ Subscribe 2005-04-11
➤ Subscribe Extended-release Injectable Suspension 39 mg/0.25 mL,78 mg/0.5 mL,117 mg/0.75 mL,156 mg/mL and234 mg/1.5 mL ➤ Subscribe 2017-11-21
➤ Subscribe Extended-release Tablets 18 mg*, 27 mg, 36 mg and 54 mg ➤ Subscribe 2005-07-19
➤ Subscribe Tablets 50 mg/500 mg, 50mg/1000 mg, 150mg/500 mg, and150 mg/1000 mg ➤ Subscribe 2017-03-29
➤ Subscribe Extended-release Capsules 16 mg and 24 mg ➤ Subscribe 2006-03-11
➤ Subscribe Tablets 25 mg, 100 mg and 200 mg ➤ Subscribe 2001-12-26
➤ Subscribe Capsules 15 mg and 25 mg ➤ Subscribe 2005-09-07
➤ Subscribe Tablets 10 mg, 15 mg, and 20 mg ➤ Subscribe 2015-07-01
➤ Subscribe Tablets 4 mg, 8 mg and 12 mg ➤ Subscribe 2005-02-28
➤ Subscribe Orally Disintegrating Tablets 3 mg and 4 mg ➤ Subscribe 2005-03-23
➤ Subscribe Extended-release Tablets 18 mg, 27 mg, 36 mg and 54 mg ➤ Subscribe 2005-07-19
➤ Subscribe Tablets 6.25 mg and 12.5 mg ➤ Subscribe 2005-12-08
➤ Subscribe Extended-release Capsules 8 mg ➤ Subscribe 2006-03-02
➤ Subscribe Tablets 100 mg and 300 mg ➤ Subscribe 2017-03-29
➤ Subscribe Oral Solution 10 mg/mL ➤ Subscribe 2013-05-03
➤ Subscribe Tablets 50 mg ➤ Subscribe 2005-09-08
➤ Subscribe Transdermal System 0.15 mg/0.02 mg per 24 hours ➤ Subscribe 2007-03-22

Supplementary Protection Certificates for Janssen Pharms Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 2190050-1 Sweden ⤷  Get Started Free PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
1651658 164 1-2014 Slovakia ⤷  Get Started Free PRODUCT NAME: KANAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/13/884/001 - EU/1/13/884/008 20131115
1651658 CR 2014 00024 Denmark ⤷  Get Started Free PRODUCT NAME: CANAGLIFLOZIN; REG. NO/DATE: EU/1/13/884/001-008 20131119
>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 PHARMS – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025

Introduction

Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, stands as a formidable player within the global pharmaceutical industry. With a diverse portfolio spanning immunology, oncology, neuroscience, infectious diseases, and vaccines, Janssen leverages its extensive research and development (R&D) capabilities to maintain competitive superiority. This analysis provides a comprehensive examination of Janssen’s market positioning, core strengths, and strategic trajectory amid an evolving pharmaceutical landscape characterized by innovation, regulatory shifts, and competitive pressures.

Market Position and Portfolio Overview

Janssen's strategic footprint encompasses over 100 countries, driven by a focus on innovative therapeutic solutions. Its portfolio's breadth and depth enable it to address critical global health needs effectively. Notably, Janssen’s oncology segment has gained prominence with blockbuster drugs like Imbruvica (ibrutinib) and Darzalex (daratumumab), which have cultivated a leading market share in hematologic cancers. Concurrently, its immunology portfolio, with Stelara (ustekinumab) and Simponi (golimumab), sustains strong revenue streams within chronic inflammatory disease markets.

Market Leadership in Select Therapeutic Areas

  • Oncology: Janssen’s early investments in targeted therapies position it as a leader in hematologic cancers.
  • Immunology: Its biologics dominate key segments, benefiting from a strong pipeline of next-generation therapies.
  • Infectious Diseases and Vaccines: With the COVID-19 pandemic underscoring the importance of vaccine innovation, Janssen’s COVID-19 vaccine Johnson & Johnson’s Janssen COVID-19 Vaccine has solidified its presence in global vaccination efforts.

Given these market positions, Janssen maintains a significant competitive advantage, particularly in differentiated biologics and specialty medicines.

Strengths and Competitive Advantages

Robust R&D Infrastructure

Janssen invests approximately €3 billion annually in R&D, fostering innovation and pipeline development. Its strategic collaborations with academia, biotech firms, and government agencies create a robust ecosystem for discovering groundbreaking therapies.

Diversified Product Portfolio

The breadth across multiple therapeutic areas reduces dependence on any single market segment, giving resiliency against market fluctuations and patent expirations.

Global Reach and Commercial Capabilities

A well-established global footprint, supported by extensive manufacturing and distribution networks, allows Janssen to penetrate emerging markets and adapt to regional regulatory environments swiftly.

Pipeline Development and Innovation

Janssen’s pipeline encompasses over 100 candidates in various clinical phases, emphasizing gene therapies, personalized medicine, and immuno-oncology. This ensures sustained growth and leadership potential in high-value segments.

Strategic Partnerships and Acquisitions

The company’s proactive collaborations—such as with Legend Biotech for CAR-T therapies—augment its innovation capabilities and accelerate product development.

Brand Recognition and Trust

Being part of Johnson & Johnson lends Janssen notable credibility, facilitating market access and consumer confidence across diverse regions.

Strategic Challenges and Risks

Intense Competition

Major competitors include Roche, Novartis, Pfizer, and Merck, investing heavily in similar therapeutic areas and pipeline advancements. Competitive overlaps in biologics and personalized medicine heighten market rivalry.

Patent Expirations and Biosimilar Threats

Patent cliffs threaten revenue streams, especially in immunology and oncology. The emergence of biosimilars could erode market share for key biologics.

Regulatory and Pricing Pressures

Healthcare systems worldwide face mounting pressure to contain drug costs. Stringent pricing regulations and reimbursement policies may impact profitability.

Pipeline Uncertainties

High R&D costs with no guarantee of successful commercialization pose inherent risks, necessitating vigilant pipeline management.

Global Supply Chain Disruptions

As a manufacturer of complex biologics and vaccines, Janssen is susceptible to supply chain disruptions, impacting product availability and revenues.

Strategic Insights and Future Outlook

Focus on Personalized Medicine

Janssen’s emphasis on precision medicine and biomarker-driven therapies aligns with industry trends toward tailor-made treatments, offering competitive differentiation.

Expansion in Asia-Pacific and Emerging Markets

Harnessing rapid healthcare infrastructure growth and unmet medical needs in these regions will be key for revenue diversification.

Leveraging Digital Technologies

Integrating digital health solutions, real-world evidence, and remote clinical trials can optimize R&D efficiency and patient engagement.

Investment in Next-Generation Therapies

Prioritizing cell and gene therapies positions Janssen at the forefront of innovative treatment modalities, potentially capturing high-growth markets.

Sustainable and Responsible Business Practices

Increasing focus on environmental, social, and governance (ESG) initiatives enhances corporate reputation, aligns with stakeholder expectations, and fosters long-term growth.

Conclusion

Janssen Pharmaceutica’s entrenched market presence, diversified portfolio, and innovation-driven strategy underpin its competitive resilience. While challenges such as patent expiries and market competition loom, Janssen’s strategic investments in R&D, emerging therapies, and global expansion safeguard its leadership position. By continuously adapting to evolving regulatory landscapes and technological advancements, Janssen is well-positioned to sustain profitable growth and maintain its status as a strategic industry leader.


Key Takeaways

  • Janssen’s diversified portfolio and global footprint afford substantial competitive advantage in high-growth therapeutic areas.
  • Heavy investment in R&D and innovation underpin its pipeline strength, emphasizing personalized medicine and next-generation therapies.
  • Strategic partnerships and acquisitions are integral to Janssen’s growth and pipeline acceleration.
  • Competitive threats include biosimilars, patent expiries, and intensified rivalry from top-tier pharma companies.
  • Focusing on emerging markets, digital health integration, and sustainable business practices will be critical to future success.

FAQs

1. How does Janssen differentiate itself in the oncology market?
Janssen focuses on targeted therapies, such as Imbruvica and Darzalex, leveraging biologics and personalized treatment approaches. Its early adoption of novel immuno-oncology modalities and strategic collaborations strengthen its market position.

2. What are Janssen’s main strategies to mitigate patent expiry risks?
Janssen emphasizes expanding its pipeline with novel biologics and biosimilars, investing in gene and cell therapies, and exploring digital health solutions to remain competitive post-patent expirations.

3. How significant is Janssen’s role in COVID-19 vaccination efforts?
Janssen’s COVID-19 vaccine has been pivotal in global vaccination campaigns, emphasizing its capacity to produce scalable biologics and strengthening its presence in infectious disease management.

4. What emerging markets present growth opportunities for Janssen?
Asia-Pacific, Latin America, and Africa offer substantial growth potential due to rising healthcare infrastructure, increasing disease prevalence, and unmet medical needs.

5. How does Janssen incorporate sustainability into its strategic plans?
Janssen aligns with Johnson & Johnson’s ESG principles, focusing on environmentally sustainable manufacturing, access to medicines, and ethical clinical research practices to support long-term stakeholder value.


Sources:

[1] Johnson & Johnson Annual Reports and Investor Briefings
[2] Evaluate Pharma, "Pharmaceutical Market Analysis"
[3] Statista, "Global Pharmaceutical Industry Revenue Data"
[4] Janssen Official Website – Product and Pipeline Updates
[5] MarketWatch, "Pharmaceutical Industry Trends and Competitive Dynamics"

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