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Last Updated: March 18, 2026

Organon Llc Company Profile


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Summary for Organon Llc
International Patents:84
US Patents:13
Tradenames:11
Ingredients:9
NDAs:11

Drugs and US Patents for Organon Llc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Llc XACIATO clindamycin phosphate GEL;VAGINAL 215650-001 Dec 7, 2021 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Organon Llc DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Organon Llc CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 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 Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 6,365,581*PED ⤷  Get Started Free
Organon Llc CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 7,214,683*PED ⤷  Get Started Free
Organon Llc ASMANEX HFA mometasone furoate AEROSOL, METERED;INHALATION 205641-002 Apr 25, 2014 6,365,581*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ORGANON LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Nasal Spray 50 mcg/ Spray ➤ Subscribe 2009-08-07
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2004-09-02
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe 2007-11-20

Supplementary Protection Certificates for Organon Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 SPC/GB13/061 United Kingdom ⤷  Get Started Free PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
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
2435024 2021019 Norway ⤷  Get Started Free PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Organon Llc: Market Position, Strengths & Strategic Insights

Last updated: February 19, 2026

Organon Llc holds a diversified portfolio in women's health, biosimil products, and established medicines, positioning it as a significant player in specific therapeutic areas. The company's market approach leverages its legacy product base, strategic acquisitions, and a focus on meeting unmet needs within its core segments. Key strengths include a broad geographic reach and established brand recognition for certain products.

What is Organon Llc's Core Business Strategy?

Organon Llc's strategy centers on providing essential medicines and improving women's health globally. The company operates through three key segments: Women's Health, Biosimil Products, and Established Brands.

Women's Health Segment

This segment represents a cornerstone of Organon's portfolio, encompassing contraception, fertility treatments, and other women's health therapeutics. The company aims to address gaps in care and expand access to reproductive health solutions.

  • Contraception: Organon has a significant presence in the contraceptive market with brands like Nexplanon (etonogestrel implant) and NuvaRing (etonogestrel/ethinyl estradiol vaginal ring). These products offer long-acting reversible contraception (LARC) options. [1]
  • Fertility: The company offers fertility treatments, contributing to its commitment to reproductive health.
  • Other Women's Health: This includes therapeutics addressing various life stages and conditions relevant to women.

Biosimilar Products Segment

Organon is actively developing and commercializing biosimilar products. This segment aims to increase access to more affordable biologic medicines by offering high-quality alternatives to originator biologics.

  • Pipeline and Launches: The company has pursued partnerships and internal development to build its biosimilar pipeline. Notable areas include oncology and immunology. [2]
  • Partnerships: Organon has engaged in strategic collaborations to expand its biosimilar offerings and market reach. For example, its agreement with Amgen for biosimilar versions of Avastin, Erbitux, and Neulasta. [3]
  • Regulatory Approvals: The company seeks regulatory approvals in major markets like the U.S. and Europe. For instance, the biosimilar bevacizumab (Abevmy) received FDA approval in May 2020. [4]

Established Brands Segment

This segment comprises a portfolio of well-established medicines across various therapeutic areas, which provide a stable revenue base for Organon. These brands often have a long history of use and patient familiarity.

  • Diverse Therapeutic Areas: This segment includes products in cardiovascular, infectious diseases, and other therapeutic categories.
  • Market Presence: Organon leverages its global commercial infrastructure to maintain and grow these established brands.

What are Organon Llc's Key Strengths?

Organon possesses several distinct strengths that underpin its market position. These include a strong foundation in women's health, a robust global presence, and a strategic approach to its biosimilar portfolio.

1. Leadership in Women's Health

Organon is recognized for its significant contribution to women's health, particularly in contraception.

  • Market Share: The company holds a substantial share in the global contraceptive market, driven by its LARC products. [1]
  • Product Innovation: Organon continues to invest in research and development for novel women's health solutions.
  • Brand Recognition: Established brands within its women's health portfolio benefit from high patient and physician recognition.

2. Extensive Global Reach and Infrastructure

Organon operates in over 140 countries, providing a significant advantage in market penetration and distribution.

  • Commercial Network: The company has a well-developed commercial and distribution network, enabling broad access to its products.
  • Emerging Markets Focus: Organon has a strategic focus on emerging markets, where unmet medical needs are often high and access to healthcare is expanding.
  • Regulatory Expertise: Navigating diverse regulatory landscapes across multiple geographies is a key operational strength.

3. Strategic Biosimilar Development

Organon's commitment to biosimil development positions it to capitalize on the growing market for affordable biologic medicines.

  • Portfolio Expansion: The company is actively building a pipeline of biosimilar candidates targeting high-value therapeutic areas.
  • Partnership Model: Organon employs a strategic partnership model to access diverse biosimilar assets and accelerate market entry. [3]
  • Cost-Effective Healthcare: By offering biosimil alternatives, Organon contributes to reducing healthcare costs for patients and health systems.

4. Diversified Product Portfolio

The combination of Women's Health, Biosimil Products, and Established Brands creates a diversified revenue stream, mitigating risks associated with reliance on a single therapeutic area or product type.

  • Revenue Stability: Established Brands provide a consistent revenue base.
  • Growth Opportunities: Women's Health and Biosimil Products offer significant growth potential.
  • Synergies: The company can leverage its commercial infrastructure across these diverse segments.

What are Organon's Strategic Priorities and Future Outlook?

Organon's strategic priorities are focused on enhancing its core Women's Health business, expanding its biosimilar offerings, and optimizing its Established Brands portfolio.

Expanding Women's Health Leadership

Organon aims to solidify its position as a leader in women's health by investing in innovation and expanding access to its products.

  • New Product Development: Focus on developing novel contraceptives and treatments addressing unmet needs in areas such as menopause and gynecologic infections.
  • Geographic Expansion: Increasing access to existing women's health products in underserved regions.
  • Partnerships for Innovation: Collaborating with research institutions and biotech companies to bring new therapies to market.

Accelerating Biosimilar Growth

The biosimilar segment is a key growth driver for Organon. The company plans to launch multiple biosimil products in the coming years.

  • Pipeline Advancement: Prioritizing the advancement of its biosimilar pipeline through regulatory approval and commercial launch.
  • Market Access: Developing strategies to ensure broad market access for its biosimilar products, focusing on value-based pricing and payer engagement.
  • Biosimilar Portfolio Diversification: Expanding into new therapeutic areas within the biosimilar market.

Optimizing Established Brands

Organon will continue to manage and optimize its portfolio of established medicines, maximizing their value and ensuring continued patient access.

  • Lifecycle Management: Implementing strategies to extend the market life of key established brands.
  • Efficiency Gains: Streamlining operations and supply chains to improve profitability for this segment.
  • Divestitures: Organon may consider divesting non-core established brands to focus resources on higher-growth areas.

How Does Organon Compare to Key Competitors?

Organon's competitive landscape is shaped by its focus on women's health, biosimil development, and its portfolio of established medicines.

Women's Health Competitors

In the women's health arena, Organon competes with large pharmaceutical companies with significant women's health divisions and specialized biotech firms.

  • Bayer: A major competitor with a comprehensive women's health portfolio including contraceptives (e.g., Mirena IUD, Yaz) and hormone therapy. Bayer also has a strong presence in fertility.
  • Pfizer: Offers a range of women's health products, including contraceptives and treatments for menopause.
  • AbbVie: Through its acquisition of Allergan, AbbVie has a strong position in women's health, particularly with its neurotoxin-based aesthetic and therapeutic products.
  • Agile Therapeutics, HRA Pharma: Smaller companies focused specifically on developing innovative contraceptive solutions.

Organon's differentiation lies in its dedicated focus as a standalone entity for women's health, coupled with its substantial LARC market share.

Biosimilar Competitors

The biosimilar market is highly competitive, with both originator companies and dedicated biosimilar manufacturers.

  • Amgen: A leader in biosimil development, with a broad portfolio and significant manufacturing capabilities. Organon has a partnership with Amgen for several biosimil products. [3]
  • Samsung Bioepis: A joint venture between Samsung and Biogen, a major player with multiple biosimilar approvals in Europe and the U.S.
  • Novartis (Sandoz): A pioneer in the biosimilar space, with one of the largest biosimilar portfolios globally.
  • Pfizer (Upjohn legacy integrated into Viatris): Viatris, formed from the merger of Mylan and Pfizer's Upjohn business, has a substantial biosimilar and generic portfolio.

Organon's strategy in biosimil relies on strategic partnerships for access to a pipeline, aiming to compete on quality, regulatory compliance, and market access.

Established Brands Competitors

Competition in the established brands segment is fragmented and depends on the specific therapeutic area. Organon competes with virtually all major pharmaceutical companies for these legacy products.

  • Large Pharma: Companies like Merck & Co., Bristol Myers Squibb, and Sanofi have extensive portfolios of established medicines.
  • Generics Manufacturers: Companies like Teva Pharmaceuticals and Viatris are major players in the generic and established medicines market, often competing on price.

Organon's approach is to leverage its existing infrastructure to maintain and grow these brands, rather than solely competing on price as a generic manufacturer might.

Key Takeaways

Organon Llc occupies a distinct market position through its strategic focus on Women's Health, its growing Biosimilar Products segment, and its stable base of Established Brands. The company's strengths lie in its dedicated women's health portfolio, extensive global infrastructure, and a partnership-driven approach to biosimilar development. Its strategic priorities involve expanding innovation in women's health, accelerating biosimilar growth through pipeline advancement and market access, and optimizing the value of its established brands. Organon competes with a range of companies across its segments, from specialized women's health firms and major biosimilar players to broad-spectrum pharmaceutical giants.

FAQs

  1. What is Organon Llc's primary therapeutic focus? Organon Llc's primary therapeutic focus is women's health, encompassing contraception, fertility, and other related areas. The company also has a significant and growing presence in biosimilar products and a portfolio of established medicines across various therapeutic categories.

  2. Which are Organon Llc's key women's health products? Key women's health products for Organon Llc include Nexplanon (etonogestrel implant) and NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), which are prominent long-acting reversible contraception (LARC) options.

  3. What is Organon Llc's strategy for its biosimilar business? Organon Llc's strategy for its biosimilar business involves developing and commercializing high-quality, more affordable alternatives to originator biologic medicines. This includes pursuing strategic partnerships to build its pipeline, seeking regulatory approvals in major markets, and focusing on market access for its biosimilar products.

  4. How does Organon Llc differentiate itself in the established medicines market? Organon Llc differentiates itself in the established medicines market by leveraging its extensive global commercial infrastructure to maintain and grow these legacy brands, rather than solely competing on price as a pure generics manufacturer. The company also aims to optimize the lifecycle of these products.

  5. What are Organon Llc's primary growth drivers for the future? Organon Llc's primary growth drivers for the future are the expansion of its women's health leadership through innovation and market access, and the acceleration of its biosimilar business through product launches and market penetration.

Citations

[1] Organon. (n.d.). Women's Health. Retrieved from https://www.organon.com/our-business/womens-health/ [2] Organon. (n.d.). Biosimil Products. Retrieved from https://www.organon.com/our-business/biosimil-products/ [3] Organon. (2021, January 12). Organon and Amgen Announce Agreement for Amgen’s Biosimilar Portfolio in Certain Territories. Retrieved from https://www.organon.com/news/organon-and-amgen-announce-agreement-for-amgens-biosimilar-portfolio-in-certain-territories/ [4] U.S. Food & Drug Administration. (2020, May 20). FDA approves Amgen’s biosimilar bevacizumab-abgs (Abevmy). Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amgens-biosimilar-bevacizumab-abgs-abejmy

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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.