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Last Updated: March 26, 2026

Organon Company Profile


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Summary for Organon
International Patents:389
US Patents:18
Tradenames:53
Ingredients:43
NDAs:60

Drugs and US Patents for Organon

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Start Trial ⤷  Start Trial
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 DISCN Yes No ⤷  Start Trial ⤷  Start Trial
Organon Usa Inc METHYLPREDNISOLONE methylprednisolone sodium succinate INJECTABLE;INJECTION 087535-002 Jun 25, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Organon Llc ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-003 Aug 12, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial
>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 Organon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon PROPECIA finasteride TABLET;ORAL 020788-001 Dec 19, 1997 5,571,817 ⤷  Start Trial
Organon Usa Inc CALDEROL calcifediol CAPSULE;ORAL 018312-002 Approved Prior to Jan 1, 1982 3,565,924 ⤷  Start Trial
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-002 Jul 23, 2004 7,229,982*PED ⤷  Start Trial
Organon Llc ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-001 Apr 25, 2014 6,365,581*PED ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ORGANON drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Tablets 50 mg/12.5 mg and 100 mg/25 mg ➤ Subscribe 2004-05-24

Supplementary Protection Certificates for Organon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 C300132 Netherlands ⤷  Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
0733366 98C0030 Belgium ⤷  Start Trial PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215
2435025 C201930043 Spain ⤷  Start Trial PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218
0497512 SPC/GB98/035 United Kingdom ⤷  Start Trial PRODUCT NAME: RIZATRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY RIZATRIPTAN BENZOATE; REGISTERED: NL 21815 19980211; NL 21816 19980211; NL 21817 19980211; NL 21818 19980211; UK 00025/0369 19980624; UK 00025/0370 19980624; UK 00025/0371 19980624; UK 00025/0372 19980624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Organon: Pharmaceutical Market Position, Strengths & Strategic Insights

Last updated: February 19, 2026

What is Organon’s Market Position in the Pharmaceutical Industry?

Organon ranks among mid-tier global pharmaceutical companies with a focus on women’s health, biosimilars, and specialty care. The company reported revenues of approximately $6.8 billion in 2022, with a compound annual growth rate (CAGR) of 7% over the past three years. It operates in over 140 countries, with key markets in North America, Europe, and emerging markets such as Asia-Pacific.

Major competitors include Pfizer, Merck & Co., and Bayer. Organon’s revenue mix is weighted toward women’s health (roughly 45%), biosimilars (25%), and established brands (30%). Its market share ranges from 2% to 4% within core segments, positioning it as a niche but growing player.

What Are Organon’s Core Strengths?

Focused Portfolio in Women’s Health

Organon specializes in reproductive health, contraception, and menopause products. Its flagship products include NuvaRing (vasoconstrictive contraceptive), and hormone replacement therapies such as Estradiol. In 2022, women’s health contributed about 45% of revenue, reflecting sustained demand for authorized products.

Robust Biosimilars Pipeline

Organon offers biosimilars for insulin glargine, Bevacizumab, and Filgrastim. As of 2023, the biosimilars platform accounts for 25% of revenue, driven by patent expirations of originator biologics. It has received approval for biosimilars in key markets, including the US, Europe, and Japan.

Strategic Asset Acquisitions

The 2021 acquisition of Alydia Health strengthened its gynecological device portfolio. Also, its partnership with companies like Biogen for neurology treatments enhances growth prospects beyond core segments.

Geographic Diversification

Sales in emerging markets are increasing, notably in Brazil, China, and India, compensating for saturation in developed markets. The company’s local partnerships deliver accelerated access and regulatory clearance.

What Are the Major Challenges Facing Organon?

Revenue Concentration

Dependence on a limited product portfolio exposes it to regulatory changes and generic erosion. NuvaRing and other flagship products face imminent patent cliffs in 2025-2027.

Competitive Biosimilar Market

Major biologic originators such as Roche and Amgen aggressively expand biosimilar portfolios, increasing pricing pressures. Organon’s biosimilar margins are under strain due to pricing competition.

Market Access Barriers

Pricing pressures in North America and Europe, especially in the US Medicaid and European health systems, impact profitability. Slow regulatory approval processes in emerging markets delay revenue realization.

Innovation Pipeline

Limited pipeline compared to larger industry players constrains future growth. R&D spending in 2022 was approximately $300 million, notably below competitors with broader portfolios.

What Strategic Movements Are Influencing Organon’s Position?

Focused R&D Investments

Organon invests predominantly in women’s health, biosimilars, and rare disease programs. The company’s R&D budget has increased since 2021, aiming for new product launches in contraception and hormone therapies by 2025.

Portfolio Optimization

Organon’s strategy involves divesting non-core assets. In 2022, it sold its women’s health division in emerging markets to private equity to sharpen focus on core segments.

Emphasis on Partnerships

Collaborations with biotech firms and technological providers foster innovation. Its partnership with Moderna for mRNA-based vaccines and therapeutics signifies diversification trends.

Market Expansion

Increased penetration in Asian markets through local manufacturing and joint ventures. The company plans to establish local R&D centers in China and India by 2024.

How Does Organon Compare to Key Competitors?

Company Core Focus Revenue (2022) R&D Spending (2022) Market Share (core segments) Key Differentiator
Organon Women’s health, biosimilars $6.8 billion $300 million 2-4% Focused portfolio, emerging markets
Pfizer Broad, including vaccines $100 billion $13 billion 10-15% Diversified R&D, global leadership
Merck & Co. Oncology, vaccines, biosimilars $59 billion $12 billion 8-12% Oncology pipeline, biologics focus
Bayer Specialty drugs, biosimilars $52 billion $4 billion 5-8% Established biosimilar portfolio

Organon’s relative positioning hinges on specialized segments, with growth driven by biosimilars and women’s health, contrasted against larger companies’ diversified portfolios.

Key Takeaways

  • Organon positions itself as a niche player, focusing on women’s health and biosimilars, with revenue growth driven by emerging markets.
  • Its reliance on flagship products facing patent expiration necessitates innovation in pipeline development.
  • Strategic acquisitions and partnerships aim to expand its portfolio and geographic reach.
  • Competition is intensifying in biosimilars, where pricing and patent challenges create margin pressure.
  • The company’s focus on emerging markets offers growth potential but exposes it to regulatory and economic risks.

FAQs

1. What is Organon’s primary revenue driver?
Women’s health products, notably contraceptives and hormone therapies, constitute roughly 45% of its revenue.

2. How does Organon’s biosimilars pipeline compare to competitors?
It has approvals for biosimilars like insulin glargine and Bevacizumab in key markets but lags behind larger biologic companies in pipeline breadth and scale.

3. What strategic risks does Organon face?
Patent expirations, pricing pressures, and pipeline limitations pose significant risks.

4. Which markets are vital for Organon’s growth?
Emerging markets, particularly China, India, and Brazil, are central to its expansion strategy.

5. How does Organon plan to innovate beyond its current portfolio?
Through R&D investments in women’s health, rare diseases, and strategic partnerships in biotechnology.


References

[1] Organon. (2022). Annual Report.
[2] IQVIA. (2022). Global Biologics & Biosimilars Report.
[3] Evaluate Pharma. (2023). Company Report.
[4] Statista. (2023). Pharmaceutical Market Analysis.
[5] WHO. (2022). Global pharmaceutical market forecasts.

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