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	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998		DISCN	Yes	No
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	No
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Organon Llc	FOSAMAX PLUS D	alendronate sodium; cholecalciferol	TABLET;ORAL	021762-002	Apr 26, 2007		RX	Yes	Yes
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No
Organon Usa Organon	GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	021057-001	Jul 29, 1999	AP	RX	Yes	Yes

Expired US Patents for Organon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	RAPLON	rapacuronium bromide	INJECTABLE;INJECTION	020984-001	Aug 18, 1999	5,418,226
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	RE42461*PED
Organon Usa Inc	NORCURON	vecuronium bromide	INJECTABLE;INJECTION	018776-002	Apr 30, 1984	4,297,351
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,969,156*PED
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	5,565,473*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	RE36481*PED

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Organon Drugs

Country	Patent Number	Estimated Expiration
Brazil	PI0706472
Japan	2007529469
Russian Federation	2361628
Taiwan	I434676
Czech Republic	301871
European Patent Office	3297605

Supplementary Protection Certificates for Organon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	98C0030	Belgium		PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0253310	C950009	Netherlands		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	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209

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: December 31, 2025

Summary

Organon, a global healthcare company specializing in women’s health, biosciences, and biosimilars, has carved out a distinctive niche within the pharmaceutical industry. As an independent entity since its spin-off from Merck in 2021, Organon’s strategic focus emphasizes reproductive health, oncology, and specialty medicines, alongside biosurgery and biosimilar segments. This analysis investigates Organon’s current market positioning, core strengths, competitive advantages, and strategic initiatives to elucidate its role within the broader pharmaceutical landscape.

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

Overview of Organon’s Market Footprint

Segment	Revenue (2022)	Key Markets	Growth Rate (CAGR 2022-2027 est.)	Market Share (est.)
Women’s Health	$2.7B	U.S., Europe, Asia-Pacific	4.5%	~2% in global women’s health segment
Biosimilars & Biosurgery	$1.2B	U.S., EU, Emerging Markets	6%	Niche but growing presence
Oncology	$650M	North America, EU	5%	Emerging presence

Source: Company Annual Report (2022), MarketsandMarkets, 2023 Estimates.

Organon’s strategic positioning leverages its strong portfolio in women’s health, with a focus on contraceptives, hormone therapy, and fertility treatments. The biosimilars segment, particularly with biosurgical and dermatological biosimilars, provides growth opportunities amid patent expirations and rising demand for cost-effective biologics.

Competitive Dynamics

• Major Competitors: Pfizer, Bayer, GSK, Novartis, and Teva.
• Differentiators: Specialization in women’s health and niche biosimilar markets.
• Market Share: Estimated at 2% globally, with higher penetration in specific regions like North America and Europe.

Regional and Segment Trends

Region	Predominant Products	Market Dynamics	Key Challenges
North America	Contraceptives, biologics	High adoption of biosimilars	Patent cliff, price pressures
Europe	Hormone therapies, biosurgical agents	Emphasis on sustainability	Stringent regulation
Asia-Pacific	Fertility solutions, biosimilars	Growing healthcare access	Regulatory complexity

What Are Organon’s Core Strengths?

1. Focused Portfolio in Women’s Health

Organon holds one of the most comprehensive portfolios in women’s reproductive health, including:

• Nexplanon (implant contraceptive)
• Yaz/Yasmin (oral contraceptives)
• Fertility treatments like Follistim
• Recent acquisitions augmenting its offerings

2. Robust Biosimilars and Biosurgery Segment

The company’s biosimilars division targets high-growth biologics markets:

• Key products: Biosimilar versions of reference biologics for oncology and immunology.
• Market strategy: Focus on cost-effective biologics to replace expensive originator products.

3. Strategic Acquisition and Alliances

• Acquisition of Forendo Pharma (2021) for endometriosis and reproductive health innovations.
• Collaborations with Lilly and other biotech firms (2022-23) for R&D pipelines and market access.

4. Geographic Diversification

Organon’s global footprint reduces reliance on any single market, ensuring resilience amid regional regulatory shifts and economic volatility.

5. Commitment to Innovation and Sustainability

• R&D investment (~$250M annually).
• Focus on sustainable manufacturing, eco-friendly packaging, and inclusive healthcare policies.

What Are Organon’s Key Strategic Advantages?

Advantage	Explanation
Specialization	Deep domain expertise in women’s health differentiates Organon from broader pharma companies.
Portfolio Diversification	Combining pharmaceuticals, biosimilars, biosurgery, and consumer health tools.
Agility Post-Spinoff	As a standalone entity, Organon can swiftly pivot strategies without Merck’s broader corporate overhead.
Focused R&D	Tailored investments in reproductive health innovations and biosimilars R&D pipelines.
Geographical Presence	Strong foothold in core markets, with an expanding footprint in emerging economies.

What Are the Strategic Challenges Facing Organon?

1. Patent Expirations & Pricing Pressures

• Next-generation biosimilars face intense competition from established players.
• Price erosion in key markets, particularly North America and Europe.

2. Regulatory Stringency

• Navigating complex approval pathways for biosimilars and biosurgery products.
• Reimbursement hurdles in emerging markets.

3. Limited Oncology Portfolio Compared to Peers

• Competing with larger firms with diversified oncology pipelines.
• Strategic need to expand indications and pipeline breadth.

4. Market Penetration

• Increasing competition in women's health, especially in contraceptive space.
• Challenges in gaining share in low-penetration markets.

How Is Organon Differentiating Itself From Competitors?

Product Portfolio and Innovation

• Focusing on niche reproductive health solutions that competitors often overlook.
• Leveraging biosimilar cost advantages in emerge markets.

Strategic Collaborations and Acquisitions

• Tapping into innovative R&D via partnerships.
• Acquiring targeted assets to accelerate growth.

Operational Efficiencies

• Streamlining manufacturing and supply chain for cost leadership.
• Commitment to sustainability enhancing brand reputation.

Customer-Centric Approach

• Engaging healthcare providers with tailored educational programs.
• Expanding patient access in underserved populations.

Comparison Table of Key Competitors

Company	Core Focus	Market Share (Global)	Notable Assets	Strategic Moves (2022-23)
Pfizer	Broad portfolio, vaccines, biologics	~10%	Prevnar, Ibrance	Expand biosimilar & immuno-oncology pipeline
Bayer	Women’s health, oncology	~4%	Mirena, Xarelto	Reinvest in biosimilars and digital health
GSK	Bio/pharma, vaccines	~3%	Shingrix, Oncology pipeline	Partnerships in rare diseases
Novartis	Neuroscience, biosimilars	~4%	Cosentyx, Sandoz biosimilars	Focused on biosimilar expansion

Strategic Outlook and Future Opportunities

Growth Drivers

Driver	Description	Estimated Impact (2023-2027)
Biosimilars Expansion	Increasing biologics adoption worldwide	$3-5B market opportunity
Women’s Health Innovation	New contraceptive and fertility solutions	4-6% CAGR
Geographical Penetration	Expanding into Asia-Pacific & Latin America	Double-digit growth potential

Key Strategic Initiatives

• Accelerate pipeline development with focus on novel hormone therapies.
• Expand biosimilar portfolio into oncology and immunology.
• Strengthen digital engagement and patient support programs.
• Sustain investments in sustainability, aiming for carbon-neutral manufacturing by 2030.

Conclusion

Organon’s strategic positioning as a niche pioneer in women’s health, coupled with a focused biosimilars portfolio and agile operational model, distinguishes it from larger pharmaceutical conglomerates. While challenges persist in competition and regulatory landscapes, its targeted investment strategies, geographic diversification, and commitment to innovation foster resilience and growth potential. Continued execution on pipeline expansion and strategic alliances will be paramount in sustaining its competitive edge.

Key Takeaways

• Organon excels in women’s health, with a comprehensive portfolio and innovation-driven approach.
• Biosimilars and biosurgery represent significant growth opportunities amid patent cliffs.
• Its independence from Merck affords agility but requires continued focus on expanding market share.
• Competitive threats include pricing pressures, regulatory hurdles, and mounting competition.
• Future growth hinges on pipeline innovation, global expansion, and strategic collaborations.

FAQs

Q1: How does Organon’s focus on women’s health differentiate it from its competitors?
Organon specializes exclusively in women’s health and reproductive services, enabling tailored innovation, dedicated R&D, and targeted market strategies, unlike broad-spectrum pharmaceutical firms.

Q2: What are the primary growth areas for Organon in the next five years?
Biosimilars, especially in oncology, expanding women’s health solutions, and increased penetration in emerging markets are primary growth drivers.

Q3: How resilient is Organon against patent expirations?
The company leverages its biosimilars and new product pipelines to offset patent cliff impacts, although intense competition and pricing pressures remain challenges.

Q4: What strategic moves should Organon prioritize to enhance market share?
Investing in novel product development, expanding biosimilar portfolio, forging regional partnerships, and reinforcing patient engagement are critical.

Q5: How does Organon plan to address regulatory challenges globally?
By investing in local regulatory expertise, adhering to regional standards proactively, and engaging with policymakers to streamline approval processes.

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Sources:
[1] Organon Annual Report 2022.
[2] MarketsandMarkets. "Biosimilars Market by Type, Application, Region - Global Forecast to 2027," 2023.
[3] Company press releases and strategic updates (2021-2023).