You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Ortho Mcneil Janssen Company Profile


✉ Email this page to a colleague

« Back to Dashboard


What is the competitive landscape for ORTHO MCNEIL JANSSEN

ORTHO MCNEIL JANSSEN has seven approved drugs.



Summary for Ortho Mcneil Janssen
US Patents:0
Tradenames:9
Ingredients:6
NDAs:7

Drugs and US Patents for Ortho Mcneil Janssen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Janssen URISPAS flavoxate hydrochloride TABLET;ORAL 016769-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Janssen ORTHO-NOVUM 10/11-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018354-002 Jan 11, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Janssen DITROPAN oxybutynin chloride SYRUP;ORAL 018211-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Janssen TOLECTIN DS tolmetin sodium CAPSULE;ORAL 018084-001 Approved Prior to Jan 1, 1982 DISCN 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 Ortho Mcneil Janssen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 6,132,420 ⤷  Get Started Free
Ortho Mcneil Janssen TOLECTIN tolmetin sodium TABLET;ORAL 017628-001 Approved Prior to Jan 1, 1982 3,752,826 ⤷  Get Started Free
Ortho Mcneil Janssen TOLECTIN DS tolmetin sodium CAPSULE;ORAL 018084-001 Approved Prior to Jan 1, 1982 3,752,826 ⤷  Get Started Free
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 6,156,331 ⤷  Get Started Free
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 6,235,712 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Last updated: August 3, 2025

Introduction

Ortho McNeil Janssen, a prominent segment within Johnson & Johnson’s family, operates at the forefront of the pharmaceutical industry, specializing in innovative therapeutic solutions across neurology, immunology, and primary care. As the pharmaceutical landscape becomes increasingly competitive, understanding Ortho McNeil Janssen’s market positioning, strategic strengths, and future growth opportunities is critical for stakeholders. This analysis delivers a comprehensive overview of the company’s current footprint, competitive advantages, and strategic pathways to sustain and enhance its market standing.

Market Position Overview

Ortho McNeil Janssen has established a substantial footprint in the global pharmaceutical sector, backed by a diversified portfolio spanning prescription drugs, vaccines, and specialty medicines. It ranks among the top-tier pharmaceutical companies, benefiting from Johnson & Johnson’s extensive distribution network and research capabilities. Its core markets include North America, Europe, and select emerging economies, with a strategic emphasis on expanding globally.

Key products such as Stelara (ustekinumab) for Crohn’s disease and psoriasis, Invega (paliperidone) for schizophrenia, and Remicade (infliximab) for autoimmune diseases underpin its revenue streams, reinforcing its leadership in immunology and neuroscience. According to earnings reports, the company's pharmaceutical segment consistently outperforms some competitors due to robust sales of these blockbuster drugs.

However, legal challenges, patent expirations, and impending biosimilar entries introduce competitive pressures. The company’s ability to maintain leadership depends on strategic innovation, lifecycle management of existing assets, and entry into high-growth therapy areas.

Strengths of Ortho McNeil Janssen

Robust R&D and Innovation Pipeline

Ortho McNeil Janssen invests heavily in research and development, with annual R&D expenditure often exceeding $3 billion. This commitment fuels an extensive pipeline of innovative therapies, especially in immunology, oncology, and neurodegenerative diseases. Recent approvals, including novel biologics and biosimilars, bolster its competitive edge and future revenue streams.

Strong Brand Portfolio and Market Penetration

Its flagship products enjoy high brand recognition and trust among clinicians, which facilitates market penetration and loyalty. The company's strategic acquisitions and licensing agreements extend its reach, enabling it to offer comprehensive therapy solutions across multiple indications.

Global Reach and Distribution Network

Leveraging Johnson & Johnson’s vast global distribution infrastructure ensures rapid product access and availability in emergent markets. This extensive network mitigates supply chain disruptions and enhances market resilience.

Regulatory Expertise and Compliance

Ortho McNeil Janssen benefits from Johnson & Johnson’s established regulatory compliance processes, facilitating smoother approvals and market entries. This advantage is critical amid shifting regulatory landscapes, especially around biologics and biosimilars.

Commitment to Digital Health and Personalized Medicine

The company has adopted digital health technologies, telemedicine integrations, and precision medicine approaches to tailor therapeutic solutions, aligning with industry trends and patient-centric care models.

Strategic Insights

1. Navigating Patent Expirations and Biosimilar Competition

Patent cliffs pose a significant challenge. Ortho McNeil Janssen must accelerate biosimilar development and diversify their portfolio with next-generation biologics to mitigate revenue losses. For example, pre-emptive lifecycle management strategies—such as reformulations, new indications, or delivery methods—can prolong product viability.

2. Expanding in High-Growth Therapeutic Areas

Emerging fields like immuno-oncology, rare diseases, and neurology present substantial growth opportunities. Collaborations with biotech startups and academic institutions can enhance pipeline robustness in these sectors.

3. Embracing Digital Transformation

Enhancing patient engagement through digital health platforms and real-world evidence (RWE) collection can optimize drug development and post-market surveillance, ensuring sustained competitive advantage.

4. Market Diversification

Expanding into underpenetrated markets, such as Asia-Pacific and Latin America, will diversify revenue streams and buffer against macroeconomic or policy shifts in mature markets.

5. Strategic Collaborations and M&A

Forming strategic alliances, mergers, or acquisitions with emerging biotech firms can accelerate innovative product development and bolster the pipeline.

6. Emphasizing Sustainability and Compliance

Proactive engagement in sustainability initiatives and regulatory compliance can enhance corporate reputation and reduce legal or compliance risks, which are increasingly scrutinized by stakeholders.

Competitive Landscape Context

Compared to peers like Pfizer, Roche, and Novartis, Ortho McNeil Janssen maintains a competitive edge through its integrated approach—combining innovative R&D, global deployment, and a diversified pipeline. Nonetheless, rivals’ aggressive biosimilar strategies and investments in gene therapy necessitate ongoing strategic adaptations.

For instance, Roche’s leadership in personalized medicine and Novartis’s breakthroughs in gene editing exemplify the evolving competitive benchmarks. Ortho McNeil Janssen must continue to innovate and adapt to these developments to preserve its market position.

Conclusion

Ortho McNeil Janssen stands as a heavyweight in the pharmaceutical industry, driven by robust R&D, a diversified portfolio, and strategic global positioning. Its ability to navigate patent expirations, harness innovation in emerging therapeutic areas, and leverage digital health will dictate its sustained market dominance. Proactive strategic planning and adaptability remain essential as competition intensifies and the industry transforms.

Key Takeaways

  • Strong R&D Investment underpins a promising pipeline, particularly in immunology and rare diseases.
  • Patent expirations necessitate diversification into biosimilars and innovative therapies to sustain revenue.
  • Global expansion into emerging markets provides growth opportunities and reduces reliance on mature markets.
  • Digital health integration enhances patient engagement, data collection, and personalized treatment approaches.
  • Strategic collaborations and acquisitions are crucial for expanding therapeutic offerings and pipeline robustness.

FAQs

1. How does Ortho McNeil Janssen’s R&D investment compare to its competitors?
Ortho McNeil Janssen’s annual R&D expenditure surpasses $3 billion, positioning it among the highest in the industry and underpinning a robust pipeline that aims to sustain its commercial leadership.

2. What are the main challenges facing Ortho McNeil Janssen?
Key challenges include patent expirations, biosimilar competition, regulatory hurdles, and market access issues in emerging economies.

3. How is digital health influencing Ortho McNeil Janssen’s strategic direction?
Digital health initiatives enable personalized therapies, improve patient adherence, and facilitate real-world evidence collection, thus supporting drug development and commercialization strategies.

4. Which therapeutic areas are prioritized by Ortho McNeil Janssen for future growth?
High-priority areas include immunology, oncology, neurology, and rare diseases, where emerging therapies are gaining regulatory and clinical traction.

5. What role do strategic partnerships play in the company’s growth?
Partnerships with biotech firms, academic institutions, and healthcare providers accelerate innovation, expand the pipeline, and facilitate market entry into high-growth regions.


Sources:

  1. Johnson & Johnson Annual Report 2022.
  2. IQVIA Institute for Human Data Science. "The Global Use of Medicines in 2022."
  3. EvaluatePharma. "Top Global Pharmaceutical Companies by Revenue."
  4. Pharmaceutical Technology. "Biosimilars and Patent Cliffs."
  5. McKinsey & Company. "Digital Transformation in Pharma."

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.