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Last Updated: February 14, 2025

Ortho Mcneil Pharm Company Profile


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What is the competitive landscape for ORTHO MCNEIL PHARM

ORTHO MCNEIL PHARM has twenty-nine approved drugs.



Summary for Ortho Mcneil Pharm
US Patents:0
Tradenames:32
Ingredients:17
NDAs:29

Drugs and US Patents for Ortho Mcneil Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-003 Mar 31, 1992 DISCN No No ⤷  Try for Free ⤷  Try for Free
Ortho Mcneil Pharm TYLENOL W/ CODEINE acetaminophen; codeine phosphate TABLET;ORAL 085056-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Ortho Mcneil Pharm THEOPHYL theophylline TABLET, CHEWABLE;ORAL 086506-001 Sep 12, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free
Ortho Mcneil Pharm TYLENOL W/ CODEINE acetaminophen; codeine phosphate TABLET;ORAL 085056-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Ortho Mcneil Pharm THEOPHYL-225 theophylline ELIXIR;ORAL 086485-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for 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 Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992 4,382,892 ⤷  Try for Free
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 4,382,892 ⤷  Try for Free
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-003 Mar 31, 1992 4,382,892 ⤷  Try for Free
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% ofloxacin INJECTABLE;INJECTION 020087-001 Mar 31, 1992 4,382,892 ⤷  Try for Free
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-005 Mar 31, 1992 4,382,892 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
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Pharmaceutical Competitive Landscape Analysis: Ortho McNeil Pharm – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Ortho McNeil Pharmaceutical, a former subsidiary of Johnson & Johnson, has played a significant role in shaping the industry. This comprehensive analysis delves into Ortho McNeil's market position, strengths, and strategic insights, providing valuable information for industry professionals and decision-makers.

The Evolution of Ortho McNeil Pharmaceutical

Ortho McNeil Pharmaceutical was formed in 1993 through the merger of Ortho Pharmaceutical and McNeil Pharmaceutical[4]. These companies were pioneers in various therapeutic areas, including pain management, acid reflux disease, and infectious diseases. The merger created a powerhouse in the pharmaceutical industry, leveraging the strengths of both entities.

Key Milestones

  • 1993: Formation of Ortho McNeil Pharmaceutical
  • 2011: Transition to operate under Janssen Pharmaceuticals name[4]

Market Position and Product Portfolio

Ortho McNeil Pharmaceutical established a strong market presence through its diverse product portfolio. The company focused on several key therapeutic areas, positioning itself as a leader in these segments.

Notable Products

  1. Ortho Tri-cyclen (contraceptive)
  2. Ortho-Evra (contraceptive patch)
  3. Doribax (antibiotic)
  4. Elmiron (treatment for interstitial cystitis)
  5. Levaquin (antibiotic)
  6. Ultram ER (pain management)
  7. Aciphex (acid reflux treatment)
  8. Concerta (ADHD medication)[4]

This diverse portfolio allowed Ortho McNeil to cater to various medical needs, strengthening its market position across multiple therapeutic areas.

Strategic Partnerships and Collaborations

Ortho McNeil Pharmaceutical recognized the importance of strategic partnerships in driving innovation and expanding market reach. One notable collaboration was with Bayer AG for the development and marketing of a key thrombosis drug.

"With this agreement we have reached another important milestone for our promising antithrombotic drug. We are very pleased to be able to further develop this drug together with Johnson & Johnson"[1]

This partnership, announced in 2005, involved the joint development and marketing of BAY 59-7939, a Factor Xa inhibitor for the prevention and treatment of thrombosis[1]. The collaboration highlighted Ortho McNeil's commitment to expanding its product pipeline and leveraging external expertise.

Key Terms of the Bayer AG Partnership

  • Shared global development costs
  • Upfront payment and milestone-based payments totaling $290 million
  • Royalties of up to 30% based on sales thresholds
  • Exclusive marketing rights in the U.S. for cardiology, primary care, and hospital specialty markets[1]

Research and Development Focus

Ortho McNeil Pharmaceutical maintained a strong focus on research and development, recognizing its importance in driving long-term growth and maintaining a competitive edge in the pharmaceutical industry.

R&D Strategy

  1. Investing in innovative therapies
  2. Focusing on unmet medical needs
  3. Leveraging internal expertise and external collaborations
  4. Advancing clinical trials for promising drug candidates

Sales and Marketing Approach

Ortho McNeil Pharmaceutical employed a robust sales and marketing strategy to promote its products effectively. The company utilized a combination of traditional and innovative approaches to reach healthcare providers and patients.

Key Elements of Sales Strategy

  1. Targeted marketing to office-based physicians and specialists
  2. Promotion in community hospitals
  3. Utilization of clinical reports and marketing materials
  4. Focus on increasing market awareness about products[2]

Competitive Advantages

Ortho McNeil Pharmaceutical possessed several competitive advantages that contributed to its success in the pharmaceutical industry.

Strengths

  1. Diverse product portfolio spanning multiple therapeutic areas
  2. Strong research and development capabilities
  3. Backing of Johnson & Johnson, providing financial stability and resources
  4. Established relationships with healthcare providers and key opinion leaders
  5. Expertise in navigating regulatory processes

Challenges and Legal Issues

Despite its successes, Ortho McNeil Pharmaceutical faced challenges and legal issues that impacted its operations and reputation.

Topamax Lawsuits

In 2010, Ortho McNeil pled guilty to a misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for unapproved uses[4]. This resulted in:

  • A fine of $6.14 million
  • Johnson & Johnson paying $75.37 million to resolve civil allegations under the False Claims Act

Additionally, the company faced civil lawsuits related to birth defects associated with Topamax use during pregnancy, resulting in significant damage awards[4].

Market Analysis and Competitive Intelligence

To maintain its competitive edge, Ortho McNeil Pharmaceutical likely employed comprehensive market analysis and competitive intelligence strategies.

Key Components of Competitive Analysis

  1. Product portfolio analysis
  2. Financial performance evaluation
  3. Patent landscape assessment
  4. Regulatory strategy analysis[5]

Technological Advancements and Innovation

Ortho McNeil Pharmaceutical recognized the importance of technological advancements in driving innovation and improving patient outcomes.

Areas of Focus

  1. Drug delivery systems
  2. Personalized medicine
  3. Digital health solutions
  4. Advanced analytics for clinical trials

Global Expansion and Market Penetration

As part of its growth strategy, Ortho McNeil Pharmaceutical likely focused on global expansion and market penetration.

Key Markets

  1. North America
  2. Europe
  3. Asia-Pacific
  4. Emerging markets

Corporate Social Responsibility and Ethical Practices

Ortho McNeil Pharmaceutical, as part of Johnson & Johnson, likely adhered to strong corporate social responsibility and ethical practices.

Focus Areas

  1. Patient safety
  2. Environmental sustainability
  3. Access to medicines in developing countries
  4. Ethical marketing practices

Future Outlook and Strategic Direction

While Ortho McNeil Pharmaceutical now operates under Janssen Pharmaceuticals, its legacy and strategic insights continue to shape the pharmaceutical landscape.

Key Trends Shaping the Future

  1. Personalized medicine
  2. Digital health integration
  3. Focus on rare diseases and unmet medical needs
  4. Emphasis on value-based healthcare

Key Takeaways

  • Ortho McNeil Pharmaceutical was a significant player in the pharmaceutical industry, with a diverse product portfolio spanning multiple therapeutic areas.
  • Strategic partnerships, such as the collaboration with Bayer AG, played a crucial role in expanding the company's market reach and product pipeline.
  • The company faced legal challenges, particularly related to the marketing of Topamax, highlighting the importance of ethical practices in the pharmaceutical industry.
  • Competitive analysis, technological innovation, and global expansion were likely key components of Ortho McNeil's strategy.
  • The legacy of Ortho McNeil continues to influence the pharmaceutical landscape, with lessons learned shaping future strategies in the industry.

FAQs

  1. What were Ortho McNeil Pharmaceutical's main therapeutic areas? Ortho McNeil focused on areas such as pain management, acid reflux disease, infectious diseases, contraception, and central nervous system disorders.

  2. How did the merger of Ortho Pharmaceutical and McNeil Pharmaceutical impact the company? The merger in 1993 created a stronger entity with a more diverse product portfolio and expanded capabilities in research, development, and marketing.

  3. What was the significance of the partnership with Bayer AG? The collaboration with Bayer AG for the development of a thrombosis drug demonstrated Ortho McNeil's commitment to expanding its product pipeline and leveraging external expertise.

  4. How did legal issues impact Ortho McNeil Pharmaceutical? The company faced significant fines and damage awards related to the marketing of Topamax, which likely impacted its reputation and financial performance.

  5. What lessons can other pharmaceutical companies learn from Ortho McNeil's experience? Key lessons include the importance of ethical marketing practices, the value of strategic partnerships, and the need for continuous innovation and adaptation in a rapidly changing industry.

Sources cited: [1] https://www.biospace.com/ortho-mcneil-pharmaceutical-inc-to-co-develop-bayer-ag-s-key-thrombosis-drug [2] https://www.indeed.com/cmp/Ortho--mcneil,-Inc [4] https://en.wikipedia.org/wiki/Ortho-McNeil_Pharmaceutical [5] https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/

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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. 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.