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Last Updated: December 28, 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 IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 DISCN No No 9,757,552 ⤷  Get Started Free Y ⤷  Get Started Free
Organon Usa Inc MAXIBOLIN ethylestrenol ELIXIR;ORAL 014006-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-002 Nov 10, 1998 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon Usa Inc DURABOLIN nandrolone phenpropionate INJECTABLE;INJECTION 011891-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Organon Usa Organon REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Organon REMERON mirtazapine TABLET;ORAL 020415-003 Mar 17, 1997 DISCN Yes 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 Organon

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-004 Jul 23, 2004 RE37721*PED ⤷  Get Started Free
Organon CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 7,214,684*PED ⤷  Get Started Free
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 5,994,329*PED ⤷  Get Started Free
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 6,100,274*PED ⤷  Get Started Free
Organon COZAAR losartan potassium TABLET;ORAL 020386-003 Oct 13, 1998 5,608,075*PED ⤷  Get Started Free
Organon LIPTRUZET atorvastatin calcium; ezetimibe TABLET;ORAL 200153-004 May 3, 2013 RE42461*PED ⤷  Get Started Free
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 5,298,520*PED ⤷  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 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
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 2007-11-20

International Patents for Organon Drugs

Country Patent Number Estimated Expiration
South Korea 20070027530 ⤷  Get Started Free
Hong Kong 1115073 ⤷  Get Started Free
Brazil 112017024934 ⤷  Get Started Free
Taiwan 201705940 ⤷  Get Started Free
Norway 20033358 ⤷  Get Started Free
Russian Federation 2384347 ⤷  Get Started Free
European Patent Office 1510521 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Organon Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0247633 97C0118 France ⤷  Get Started Free PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
2435025 122019000068 Germany ⤷  Get Started Free PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218
1003503 SZ 30/2006 Austria ⤷  Get Started Free PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0497512 98C0037 France ⤷  Get Started Free PRODUCT NAME: RIZATRIPTAN BENZOATE; REGISTRATION NO/DATE IN FRANCE: NL 23 695 DU 19980817; REGISTRATION NO/DATE AT EEC: 21 815 DU 19980211
2435025 CA 2019 00032 Denmark ⤷  Get Started Free PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024 PA2021511,C2435024 Lithuania ⤷  Get Started Free PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
0720599 26/2005 Austria ⤷  Get Started Free PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
>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.