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Last Updated: December 13, 2025

Organon Company Profile


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Summary for Organon
International Patents:389
US Patents:18
Tradenames:53
Ingredients:43
NDAs:59

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 CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon Llc VTAMA tapinarof CREAM;TOPICAL 215272-001 May 23, 2022 RX Yes Yes 11,938,099 ⤷  Get Started Free ⤷  Get Started Free
Organon REMERON mirtazapine TABLET;ORAL 020415-002 Jun 14, 1996 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon SINGULAIR montelukast sodium TABLET;ORAL 020829-002 Feb 20, 1998 AB RX Yes Yes ⤷  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 Organon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 5,565,473*PED ⤷  Get Started Free
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 5,977,099 ⤷  Get Started Free
Organon ELOCON mometasone furoate OINTMENT;TOPICAL 019543-001 Apr 30, 1987 4,472,393*PED ⤷  Get Started Free
Organon Llc NASONEX mometasone furoate SPRAY, METERED;NASAL 020762-001 Oct 1, 1997 6,127,353*PED ⤷  Get Started Free
Organon PROSCAR finasteride TABLET;ORAL 020180-001 Jun 19, 1992 5,886,184 ⤷  Get Started Free
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992 4,832,957 ⤷  Get Started Free
>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 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
➤ 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

Supplementary Protection Certificates for Organon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0253310 C950009 Netherlands ⤷  Get Started Free PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902
2435024 SPC/GB21/029 United Kingdom ⤷  Get Started Free PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
1304992 2013/044 Ireland ⤷  Get Started Free PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
2435024 21C1020 France ⤷  Get Started Free PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0771217 CA 2006 00038 Denmark ⤷  Get Started Free PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0720599 C300688 Netherlands ⤷  Get Started Free PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Organon – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025


Introduction

Organon & Co. has established itself as a prominent player within the pharmaceutical and reproductive health sectors, leveraging its legacy as a guaranteed innovator in women's health, biosciences, and established pharmaceuticals. Following its spin-off from Merck & Co. in 2021, Organon is now charting an independent course in a highly competitive industry distinguished by dynamic innovation, regulatory complexities, and evolving healthcare needs. This analysis explores Organon’s current market position, core strengths, vulnerabilities, and strategic opportunities within the competitive pharmaceutical landscape.


Market Position and Business Overview

Organon primarily positions itself as a specialized healthcare provider focusing on women’s health, biosciences, and established pharmaceuticals. Its strategic focus lies in niche, high-growth markets such as contraception, osteoporosis, and other reproductive health solutions [1]. As a relatively new standalone entity, Organon operates in a market with well-entrenched competitors, including Pfizer, Bayer, and Johnson & Johnson, which possess extensive portfolios, global reach, and significant R&D resources.

Organon’s global footprint, with leadership in several regions including North America, Europe, and select emerging markets, affords it a competitive advantage in tailored healthcare solutions. Its portfolio boasts over 50 marketed products, many of which are considered essential medicines within their respective categories [2].


Competitive Strengths

1. Focused Niche Specialization
Organon’s concentration on women’s health enables it to develop tailored marketing, R&D, and patient engagement strategies that differentiate it from broader pharmaceutical giants. Its leadership in contraceptives and reproductive health—areas with unmet needs—positions it as a go-to specialist, capturing a loyal customer base.

2. Strong Portfolio of Established Medicines
The company's portfolio comprises mature, high-margin products with consistent revenue streams—such as the intrauterine device (IUD) brands and hormone therapies—providing financial stability amid pipeline uncertainties [3].

3. Strategic R&D and Innovation Focus
Despite its emphasis on established products, Organon invests in innovative therapeutics, notably in biosimilars and new hormonal formulations. Its relatively lean, focused R&D structure allows for agility and targeted innovation in core segments.

4. Geographical Diversification
Organon leverages a diversified geographic presence to mitigate regional market risks, with significant operations across North America, Europe, and emerging markets like China and Latin America [4]. This distribution enhances revenue stability.

5. Commitment to Sustainability and Corporate Responsibility
Emphasizing environmental, social, and governance (ESG) factors aligns with stakeholder expectations and enhances brand reputation, especially among socially conscious consumers and healthcare providers.


Market Challenges & Vulnerabilities

1. Limited R&D Pipeline Compared to Major Competitors
While focusing on niche segments offers advantages, it also constrains the breadth of innovation. Major players like Pfizer and Bayer invest heavily in diversified pipelines, potentially outpacing Organon in novel therapeutics.

2. Competition from Pharm giants with Broader Portfolios
Pfizer, Bayer, and J&J possess extensive diversification, enabling rapid market penetration and pricing strategies that may challenge Organon’s market share in reproductive health.

3. Regulatory and Pricing Pressures
Pricing pressures, especially in developed markets with strict reimbursement policies, threaten margins. Additionally, regulatory hurdles in biosimilars or new hormonal therapies could slow commercial expansion.

4. Market Saturation and Demographic Shifts
In mature markets, demographic shifts such as declining birth rates may impede growth in reproductive health sectors. Conversely, emerging markets’ regulatory environments require strategic navigation.


Strategic Insights

1. Expansion Through Strategic Partnerships and Collaborations
Forming alliances with biotech firms or academic institutions can accelerate innovation in women’s health and biosciences. Collaborative R&D can augment Organon’s pipeline while sharing risk.

2. Digital Health and Patient Engagement Technologies
Investing in digital platforms for medication adherence, telemedicine integration, and patient education could strengthen loyalty and improve healthcare outcomes, aligning with modern healthcare trends.

3. Focused Market Penetration and Product Localization
Customizing product offerings to regional needs—particularly in emerging markets with high growth potential—is critical. Local regulatory compliance, culturally tailored marketing, and affordable pricing are essential.

4. Diversification into Adjacent Therapeutic Areas
Expanding into areas such as reproductive genetics or specialized hormonal therapies offers avenues for growth and diversification, reducing dependence on current core categories.

5. Enhancing R&D Capabilities
Investments in cutting-edge technologies, including biosimilars, gene therapies, and personalized medicine, can foster differentiated offerings, defend market share, and open new revenue streams.


Competitive Landscape Overview

Player Core Focus Market Share Strengths Weaknesses
Organon Women’s health, biosciences Niche, with strong presence in contraceptives Focused portfolio; geographic diversification Limited R&D pipeline; smaller scale compared to giants
Pfizer Broad portfolio including reproductive health Largest globally Extensive R&D; broad market penetration Less focus on niche areas; pricing pressures
Bayer Women’s health, oncology, specialty medicines Significant leadership in contraception Innovative pipeline; global reach Regulatory challenges; patent cliffs
J&J Consumer health, pharmaceuticals, devices Diverse portfolio Market brand strength; R&D investments Complex organizational structure; high operating costs

Key Takeaways

  • Strategic Positioning: Organon’s niche focus on women’s health and biosciences positions it favorably within specialized markets, but its growth is constrained by competitors with broader pipelines and resources.

  • Leveraging Core Strengths: Its established portfolio offers stable revenue streams, allowing investment in innovation and digital health initiatives to remain competitive.

  • Growth Opportunities: Expanding via strategic alliances, embracing digital healthcare, and exploring adjacent therapeutic areas can catalyze future growth and mitigate sector-specific risks.

  • Market Risks: Challenges include competitive intensity, regulatory hurdles, demographic shifts, and regional market dynamics requiring proactive, tailored strategies.

  • Actionable Strategy: To elevate its market position, Organon should prioritize innovation, strengthen regional presence through localization, and leverage digital tools for patient engagement and operational efficiency.


FAQs

1. How does Organon differentiate itself from competitors like Bayer and Pfizer?
Organon specializes exclusively in women’s health and biosciences, focusing on niche, high-growth segments such as contraception and reproductive health, enabling tailored marketing and innovation. In contrast, Bayer and Pfizer operate broader portfolios across multiple therapeutic areas, which dilutes focus but offers diversified revenue streams.

2. What are the main growth areas for Organon in the next five years?
Key growth areas include expanding the contraceptive portfolio, advancing biosimilars and hormone therapies, digital health integration for patient engagement, and expanding presence in emerging markets such as Asia and Latin America.

3. How significant is Organon’s pipeline concerning future competitiveness?
Although currently limited compared to industry giants, Organon’s targeted investments in biosimilars, innovative hormonal treatments, and digital health technology are strategically positioned to enhance its future competitiveness.

4. What are the primary regulatory risks facing Organon?
Regulatory uncertainties surrounding biosimilars, evolving safety standards, and approvals in emerging markets pose risks that could delay product launches or impact profitability.

5. How can Organon mitigate competitive threats from larger pharmaceutical firms?
By deepening its specialization, investing in innovative therapies, expanding regional presence, forming strategic partnerships, and leveraging digital health solutions, Organon can sustain its niche dominance and fend off broader competitors.


References

[1] Organon & Co. Corporate Overview, 2022.
[2] Company Annual Report, 2022.
[3] MarketResearch.com, Women’s Health Sector Analysis, 2022.
[4] Global Market Insights, Pharmaceutical Market Trends, 2022.

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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. 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.