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Last Updated: April 1, 2025

organon Company Profile


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Summary for organon
International Patents:313
US Patents:6
Tradenames:52
Ingredients:42
NDAs:58

Drugs and US Patents for organon

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Organon Llc ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-002 Apr 25, 2014 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 RX Yes No ⤷  Try for Free ⤷  Try for Free
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 AB RX Yes 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
Showing 1 to 4 of 4 entries

Expired US Patents for organon

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Organon COZAAR losartan potassium TABLET;ORAL 020386-002 Apr 14, 1995 5,210,079*PED ⤷  Try for Free
Organon Usa Inc NORCURON vecuronium bromide INJECTABLE;INJECTION 018776-002 Apr 30, 1984 3,553,212 ⤷  Try for Free
Organon Usa Inc RAPLON rapacuronium bromide INJECTABLE;INJECTION 020984-001 Aug 18, 1999 5,418,226 ⤷  Try for Free
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 7,030,106*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries
Paragraph IV (Patent) Challenges for ORGANON drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 50 mg/12.5 mg and 100 mg/25 mg ➤ Subscribe 2004-05-24
➤ Subscribe Tablets 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg ➤ Subscribe 2009-07-27
➤ Subscribe Nasal Spray 50 mcg/ Spray ➤ Subscribe 2009-08-07
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-09-02
➤ Subscribe Vaginal Ring 0.015 mg/24 hour and 0.12 mg/24 hour ➤ Subscribe 2013-06-17
➤ Subscribe Topical Solution (Lotion) 0.10% ➤ Subscribe 2004-06-10
➤ Subscribe Chewable Tablets 4 mg and 5 mg ➤ Subscribe 2006-12-26
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Oral Solution 70 mg/75 mL ➤ Subscribe 2007-09-07
➤ Subscribe Tablets 100 mg/12.5 mL ➤ Subscribe 2006-04-04
➤ Subscribe Tablets 10 mg ➤ Subscribe 2006-10-25
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 2007-11-20
➤ Subscribe Injection 250 mcg/0.5 mL, 1 mL PFS ➤ Subscribe 2012-03-30
➤ Subscribe Tablets 10 mg ➤ Subscribe 2007-02-20
➤ Subscribe Tablets 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Orally Disintegrating Tablets 5 mg and 10 mg ➤ Subscribe 2006-02-17

Supplementary Protection Certificates for organon Drugs

Showing 1 to 4 of 4 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Organon – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Organon has emerged as a significant player, carving out a unique niche with its focus on women's health, biosimilars, and established brands. This comprehensive analysis delves into Organon's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Organon's Market Position

Organon, a spin-off from Merck & Co., has quickly established itself as a formidable force in the global healthcare sector. The company's strategic focus on women's health and biosimilars has positioned it at the forefront of these rapidly growing markets.

Women's Health Portfolio

Organon's women's health portfolio is a cornerstone of its business strategy. The company has a strong presence in this segment, with a market share of 18.4% and annual revenue of $1.87 billion[3]. This specialized focus sets Organon apart from many of its competitors and aligns well with the growing emphasis on women's health issues globally.

Biosimilars Market

In the burgeoning biosimilars market, Organon has made significant strides. The company's biosimilars segment holds a 12.6% market share, generating annual revenue of $1.23 billion[3]. This strong performance in biosimilars demonstrates Organon's ability to compete effectively in a highly competitive and rapidly evolving market segment.

Established Brands

Organon's portfolio of established brands spans various therapeutic areas, including cardiovascular disease, respiratory conditions, and non-opioid pain management. These products, while often beyond market exclusivity, continue to contribute meaningfully to the company's profitability and provide a stable revenue base[6].

Organon's Key Strengths

Specialized Focus on Women's Health

Organon's dedicated portfolio targeting women's healthcare is a significant strength. The global women's healthcare market, valued at $27.5 billion in 2023, is projected to reach $42.6 billion by 2030[3]. This focused approach allows Organon to capitalize on the growing demand for women's health products and services.

Strong Product Portfolio

With 48 marketed products and an average product lifecycle of 7-12 years, Organon boasts a robust and diverse product portfolio. This diversity helps mitigate risks associated with individual product performance and provides multiple avenues for growth[3].

Research and Development Capabilities

Leveraging its heritage from Merck, Organon maintains robust R&D capabilities. In 2023, the company invested $612 million in R&D, filed 27 new patents, and had three new drug applications in the pipeline[3]. This commitment to innovation is crucial for long-term growth and competitiveness in the pharmaceutical industry.

Experienced Management Team

Organon's leadership team comprises pharmaceutical executives with an average of over 15 years of industry experience. This wealth of experience and diverse global management background provides the company with valuable insights and strategic direction[3].

Solid Financial Foundation

The company's strong financial performance is evident in its 2023 results, with total revenue of $6.5 billion, net income of $892 million, and an operating margin of 22.3%[3]. This solid financial foundation provides Organon with the resources to invest in growth opportunities and navigate market challenges.

Strategic Insights and Future Growth Prospects

Expansion in Women's Health

Organon's strategy to expand its women's health portfolio aligns well with market trends. The women's health market is expected to reach $42.7 billion by 2027, presenting significant growth opportunities[4]. The company's focus on conditions unique to women or those that affect women disproportionately positions it to capture a larger share of this growing market.

Biosimilars Growth

The biosimilars market is anticipated to grow at a CAGR of 14.3% through 2026[4]. Organon's strong presence in this market, particularly with products like Hadlima, positions the company to benefit from this growth. The rapid uptake of Hadlima, which captured a 5% market share and generated $39 million in Q3 sales, demonstrates the potential for further expansion in this segment[7].

Global Expansion

Organon's global presence in 140 countries provides a strong foundation for international growth[4]. The company's planned expansion in emerging markets could unlock new revenue streams and diversify its geographical risk.

Research and Development Focus

With a projected R&D investment of $850 million in 2024 and plans to develop 3-4 new pharmaceutical products annually, Organon is positioning itself for sustained innovation and growth[4]. This focus on R&D is crucial for maintaining competitiveness in the rapidly evolving pharmaceutical landscape.

Challenges and Threats

Intense Competition

The pharmaceutical market is highly competitive, with major players like Pfizer (5.2% global market share), Merck & Co. (4.8%), and Novartis (4.5%) dominating the landscape[3]. Organon must continue to differentiate itself and innovate to maintain its market position.

Regulatory Environment

The stringent regulatory environment in the pharmaceutical industry poses ongoing challenges. With regulatory compliance costs increasing by 15% annually, Organon must navigate complex approval processes and stringent safety standards[3].

Pricing Pressures

Healthcare pricing dynamics present significant challenges, with average drug price negotiation pressure leading to 7-12% annual reductions and insurance reimbursement rates declining by 4-6% annually[3]. These pressures could impact Organon's profitability and pricing strategies.

Patent Expirations

Like all pharmaceutical companies, Organon faces risks associated with patent expirations. The company is estimated to face potential revenue losses of $3.2 billion by 2026 due to patent expirations, with generic competition potentially leading to 40-60% price erosion for affected medications[3].

Strategic Recommendations

Invest in Women's Health Innovation

Given Organon's strong position in women's health, continued investment in this area is crucial. Developing innovative treatments for conditions unique to women or those that disproportionately affect women could further solidify the company's market leadership.

Expand Biosimilars Portfolio

The success of Hadlima demonstrates the potential of Organon's biosimilars business. Expanding this portfolio through partnerships or in-house development could drive significant growth.

Leverage Global Presence

Organon should capitalize on its presence in 140 countries to drive growth in emerging markets. Tailoring strategies to local healthcare needs and regulatory environments could unlock new revenue streams.

Focus on R&D Efficiency

While increasing R&D investment is important, Organon should also focus on improving R&D efficiency to maximize returns on investment. This could involve adopting new technologies, streamlining processes, or forming strategic partnerships.

Diversify Revenue Streams

To mitigate risks associated with patent expirations and pricing pressures, Organon should consider diversifying its revenue streams. This could involve expanding into adjacent therapeutic areas or exploring new business models.

Key Takeaways

  • Organon has established a strong market position in women's health and biosimilars, with significant growth potential in both segments.
  • The company's diverse product portfolio, global presence, and experienced management team are key strengths.
  • Challenges include intense competition, regulatory pressures, and potential patent expirations.
  • Strategic focus on innovation in women's health, expansion of the biosimilars portfolio, and leveraging global presence are crucial for future growth.
  • Continued investment in R&D and strategic partnerships will be essential for maintaining competitiveness in the evolving pharmaceutical landscape.
"We believe in a better and healthier every day for every woman. And we understand that women are foundational to a healthier world." - Organon[5]

This comprehensive analysis of Organon's market position, strengths, and strategic insights provides valuable information for industry professionals and investors. As the pharmaceutical landscape continues to evolve, Organon's focused strategy and strong market position in women's health and biosimilars position it well for future growth, despite the challenges inherent in the industry.

FAQs

  1. Q: What is Organon's primary focus in the pharmaceutical industry? A: Organon primarily focuses on women's health, biosimilars, and established brands across various therapeutic areas.

  2. Q: How does Organon's women's health portfolio perform in the market? A: Organon's women's health portfolio holds an 18.4% market share and generates annual revenue of $1.87 billion.

  3. Q: What is the growth potential for Organon's biosimilars business? A: The biosimilars market is expected to grow at a CAGR of 14.3% through 2026, presenting significant opportunities for Organon's biosimilars portfolio.

  4. Q: How is Organon addressing the challenges of patent expirations? A: Organon is investing in R&D, expanding its product portfolio, and diversifying its revenue streams to mitigate the impact of patent expirations.

  5. Q: What sets Organon apart from its competitors in the pharmaceutical industry? A: Organon's specialized focus on women's health, strong biosimilars portfolio, and global presence in 140 countries differentiate it from many competitors in the pharmaceutical industry.

Sources cited: [3] https://dcfmodeling.com/products/ogn-swot-analysis [4] https://dcfmodeling.com/blogs/health/ogn-financial-health [5] https://www.organon.com/uk/about-organon/ [6] https://www.organon.com/wp-content/uploads/sites/2/2023/04/2022_FY_Annual_Report.pdf [7] https://www.investing.com/news/swot-analysis/organons-swot-analysis-stock-poised-for-growth-amid-challenges-93CH-3778943

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