You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 30, 2025

Ortho Mcneil Company Profile


✉ Email this page to a colleague

« Back to Dashboard


What is the competitive landscape for ORTHO MCNEIL

ORTHO MCNEIL has thirty-eight approved drugs.



Summary for Ortho Mcneil
US Patents:0
Tradenames:42
Ingredients:22
NDAs:38

Drugs and US Patents for Ortho Mcneil

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 ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Pharm ORTHO-NOVUM 1/35-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 017489-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Pharm ESTRADIOL estradiol SYSTEM;TRANSDERMAL 021048-001 Sep 20, 1999 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Ortho Mcneil Pharm NORCEPT-E 1/35 21 ethinyl estradiol; norethindrone TABLET;ORAL-21 071545-001 Feb 9, 1989 DISCN No 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 6,113,938 ⤷  Get Started Free
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 6,156,331 ⤷  Get Started Free
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% ofloxacin INJECTABLE;INJECTION 020087-001 Mar 31, 1992 4,382,892 ⤷  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 – Market Position, Strengths & Strategic Insights

Last updated: July 29, 2025


Introduction

Ortho McNeil, a division of Johnson & Johnson, operates as a key player in the global pharmaceutical and consumer healthcare sectors, with a notable presence in prescription drugs, over-the-counter (OTC) products, and dermatological treatments. As a staple in the competitive landscape, understanding Ortho McNeil’s market positioning, core strengths, and strategic initiatives is essential for stakeholders seeking insights into its current and future growth trajectory amid rapid industry innovation and fierce competition.


Market Position of Ortho McNeil

Ortho McNeil has established itself as a formidable brand primarily through its specialized focus on dermatology, orthopedic, and women's health segments, augmented by a robust pipeline of innovative therapeutics. The division's strategic integration within Johnson & Johnson provides access to extensive R&D resources, global distribution channels, and a brand reputation grounded in quality and safety.

Market Share and Revenue Performance

While exact earnings figures fluctuate annually, estimates suggest that Ortho McNeil contributes significantly to Johnson & Johnson’s broader pharmaceutical revenues. Its dermatology portfolio, including blockbuster drugs like Claritin (loratadine) and others, maintains a dominant position in OTC allergy medications. Moreover, its prescription drug segment focuses on niche therapeutic areas such as osteoporosis and hormonal treatments, reinforcing its foothold amid generic competition.

Competitive Dynamics

In the dermatological and orthopedical markets, Ortho McNeil faces stiff competition from Pfizer, Merck, and Novartis, among others. Its ability to sustain market leadership hinges on innovation, regulatory agility, and effective commercialization of new products. The competitive landscape is further intensified by the rise of biosimilars and generics, demanding continuous R&D investment to preserve exclusivity and market share.


Core Strengths of Ortho McNeil

1. Strong Portfolio of Established Brands

Ortho McNeil's robust portfolio includes globally recognized OTC products like Claritin and oral contraceptives, which generate consistent revenue streams. The resilience of these brands is bolstered by long-standing consumer loyalty and extensive marketing, establishing a formidable barrier against competitors.

2. R&D and Innovation Capacity

Leveraging Johnson & Johnson’s deep R&D pipeline, Ortho McNeil invests considerably in developing novel therapeutics and formulations. Its pipeline emphasizes biologics, targeted therapies, and personalized medicine—areas projected to dominate future pharmaceutical markets.

3. Global Distribution and Market Penetration

The division benefits from Johnson & Johnson’s expansive global footprint, enabling rapid market penetration and localized adaptations. Its extensive distribution network ensures product availability in both developed and emerging markets, diversifying risk and revenue sources.

4. Regulatory Expertise and Compliance

Ortho McNeil’s longstanding experience with regulatory bodies enhances its ability to navigate complex approval processes efficiently. This competence allows the company to expedite product launches and adjust swiftly to regulatory changes, maintaining a competitive edge.

5. Strategic Collaborations and Partnerships

The division actively engages in strategic alliances, licensing agreements, and acquisition activities. These collaborations expand its therapeutic pipeline, complement existing product offerings, and facilitate entry into emerging sectors like biosimilars and specialty drugs.


Strategic Insights

Innovation and Sustained R&D Investment

To stay ahead, Ortho McNeil must prioritize continuous innovation. Emphasizing biologics, gene therapies, and personalized medicine will be essential as the industry shifts toward highly targeted treatments. Strengthening ties with biotech startups through strategic partnerships could catalyze breakthrough therapies.

Harnessing Digital Technologies

Integrating digital health solutions, such as telemedicine platforms and digital therapeutics, offers new revenue streams and enhances patient engagement. Data analytics can optimize R&D processes and personalize marketing efforts, improving product outcomes and consumer loyalty.

Expansion into Emerging Markets

Emerging markets offer substantial growth opportunities, driven by rising healthcare expenditures and increasing disease prevalence. Ortho McNeil’s ability to adapt product portfolios to local needs and price sensitivities can unlock significant market share gains.

Focus on Biosimilars and Generics

The proliferation of biosimilars poses both challenges and opportunities. Ortho McNeil’s strategic development of cost-effective biosimilar products could secure market share against originator biologics, especially in the wake of patent expirations.

Regulatory Agility and Risk Management

Staying ahead of evolving regulatory landscapes mandates a proactive stance on compliance, especially in jurisdictions with heightened scrutiny. Developing agile regulatory response teams can facilitate faster approvals and mitigation of compliance risks.


Conclusion

Ortho McNeil’s steadfast market position is fortified by its diverse product portfolio, strong R&D focus, and global operational prowess. To sustain competitiveness, the division must leverage emerging technological trends, expand into high-growth markets, and adapt to industry shifts. Strategic investments in innovation, digital transformation, and biosimilars will be pivotal for maintaining its leadership amid a dynamic pharmaceutical landscape.


Key Takeaways

  • Ortho McNeil enjoys a competitive edge through its established portfolio, especially OTC brands like Claritin, and its integration within Johnson & Johnson’s global infrastructure.
  • Continuous innovation and investment in biologics and personalized medicine will be critical for future growth.
  • Expanding into emerging markets and leveraging digital health technologies can unlock new revenue streams.
  • Navigating biosimilar opportunities and patent expirations is vital to sustain market relevance.
  • Maintaining regulatory agility and strategic partnerships will underpin resilience in an evolving industry.

FAQs

1. How does Ortho McNeil differentiate itself from competitors in the pharmaceutical industry?
Ortho McNeil leverages its strong portfolio of trusted brands, extensive R&D capabilities, and global distribution network—the result of its integration within Johnson & Johnson—to deliver innovative, high-quality therapeutics across multiple markets.

2. What are the key growth areas for Ortho McNeil moving forward?
The division’s primary growth vectors include biologics and personalized therapies, digital health integration, expansion into emerging markets, and biosimilar development.

3. How does Ortho McNeil manage patent expirations and competition from generics?
By investing in R&D to develop next-generation medications, engaging in strategic alliances, and entering biosimilar markets, Ortho McNeil aims to sustain competitive advantage against generic and biosimilar entrants.

4. What role does digital transformation play in Ortho McNeil’s strategic future?
Digital health initiatives enable enhanced patient engagement, real-time data collection, and improved R&D efficiency—supporting innovation and personalized patient care.

5. How does Ortho McNeil capitalize on emerging markets?
It adapts its product offerings to local healthcare needs and price points, builds local partnerships, and leverages Johnson & Johnson’s vast distribution network to increase market penetration.


Sources

[1] Johnson & Johnson Annual Report 2022.
[2] MarketWatch, "Pharmaceutical Industry Analysis," 2023.
[3] Statista, "Global OTC Drug Market," 2022.
[4] EvaluatePharma, "Pharmaceutical Pipeline & R&D," 2023.
[5] McKinsey & Company, "Pharmaceutical Industry Trends," 2022.

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.