ORGANON Company Profile

What is the competitive landscape for ORGANON

ORGANON has fifty-nine approved drugs.

There are eighteen US patents protecting ORGANON drugs. There is one tentative approval on ORGANON drugs.

There are three hundred and eighty-nine patent family members on ORGANON drugs in fifty-three countries and one hundred and forty-one supplementary protection certificates in fifteen countries.

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 Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010		RX	Yes	Yes
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014		RX	Yes	Yes
Organon Usa Inc	DESOGEN	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020071-002	Dec 10, 1992		DISCN	No	No
Organon Usa Inc	LIQUAMAR	phenprocoumon	TABLET;ORAL	011228-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994		DISCN	Yes	No
Organon	ELOCON	mometasone furoate	LOTION;TOPICAL	019796-001	Mar 30, 1989		DISCN	Yes	No
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991	AB	RX	Yes	No

Expired US Patents for ORGANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982	3,769,424
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997	6,127,353*PED
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	RE29892
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007	5,358,941*PED
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	4,832,957
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,153,197*PED
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	6,090,410*PED

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Solution	70 mg/75 mL		2007-09-07
	Tablets	100 mg/12.5 mL		2006-04-04
	Tablets	10 mg		2006-10-25
	Tablets	70 mg/2800 IU and 70 mg/5600 IU		2007-11-20
	Injection	250 mcg/0.5 mL, 1 mL PFS		2012-03-30
	Tablets	10 mg		2007-02-20
	Tablets	5 mg		2006-06-21
	Orally Disintegrating Tablets	5 mg and 10 mg		2006-02-17
	Tablets	50 mg/12.5 mg and 100 mg/25 mg		2004-05-24
	Tablets	10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg		2009-07-27
	Nasal Spray	50 mcg/ Spray		2009-08-07
	Tablets	5 mg and 10 mg		2004-09-02
	Vaginal Ring	0.015 mg/24 hour and 0.12 mg/24 hour		2013-06-17
	Topical Solution (Lotion)	0.10%		2004-06-10
	Chewable Tablets	4 mg and 5 mg		2006-12-26
	Orally Disintegrating Tablets	2.5 mg and 5 mg		2006-06-21

International Patents for ORGANON Drugs

Country	Patent Number	Estimated Expiration
Slovakia	288217
European Patent Office	2039357
Japan	2009132745
World Intellectual Property Organization (WIPO)	2016185428
Taiwan	I705831
Argentina	066143
Hong Kong	1056695

Supplementary Protection Certificates for ORGANON Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	C990009	Netherlands		PRODUCT NAME: MONTELUKASTUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NATRII MONTELUKASTUM; NATL REGISTRATION NO/DATE: RVG 23164 AND RVG 23165 19981103; FIRST REGISTRATION: FI 12766 AND 12767 19970825
0497512	9891028-4	Sweden		PRODUCT NAME: RIZATRIPTAN, N.N-DIMETYL-2-(5-(1, 2, 4-TRIAZOL-1-YLMETYL)-1H-INDOL-3-YL)ET)-1H-I, EVENTUELLT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT, SPECIELLT DA RIZATRIPTANBENSOAT
2481400	132021000000071	Italy		PRODUCT NAME: CALCIFEDIOLO(RAYALDEE); AUTHORISATION NUMBER(S) AND DATE(S): 047870011, 20201201;PL 50784/0005, 20200721
2435024	CA 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
0287150	96C0038	Belgium		PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
0497512	98C0037	France		PRODUCT NAME: RIZATRIPTAN BENZOATE; REGISTRATION NO/DATE IN FRANCE: NL 23 695 DU 19980817; REGISTRATION NO/DATE AT EEC: 21 815 DU 19980211

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Organics Lagrange
• Organon
• Organon Llc
• Organon Usa Inc
• Organon Usa Organon

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

Last updated: July 27, 2025

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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.

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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].

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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.

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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.

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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.

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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

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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.

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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.

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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.