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Last Updated: July 10, 2025

Emd Serono Company Profile


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Summary for Emd Serono
International Patents:138
US Patents:11
Tradenames:9
Ingredients:8
NDAs:10

Drugs and US Patents for Emd Serono

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes 8,927,540 ⤷  Try for Free ⤷  Try for Free
Emd Serono Inc GEREF sermorelin acetate INJECTABLE;INJECTION 020443-002 Sep 26, 1997 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes 9,062,029 ⤷  Try for Free Y ⤷  Try for Free
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes 7,713,947 ⤷  Try for Free ⤷  Try for Free
Emd Serono Inc EUTHYROX levothyroxine sodium TABLET;ORAL 021292-003 May 31, 2002 AB2 RX No No ⤷  Try for Free ⤷  Try for Free
Emd Serono Inc EUTHYROX levothyroxine sodium TABLET;ORAL 021292-012 May 31, 2002 DISCN No No ⤷  Try for Free ⤷  Try for 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 Emd Serono

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-002 Aug 11, 2000 6,863,891 ⤷  Try for Free
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 6,863,891 ⤷  Try for Free
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-001 Dec 23, 1987 4,617,319 ⤷  Try for Free
Emd Serono GEREF sermorelin acetate INJECTABLE;INJECTION 019863-001 Dec 28, 1990 4,517,181 ⤷  Try for Free
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-003 Dec 23, 1987 4,820,738 ⤷  Try for Free
Emd Serono Inc GEREF sermorelin acetate INJECTABLE;INJECTION 020443-001 Sep 26, 1997 4,517,181 ⤷  Try for Free
Emd Serono NOVANTRONE mitoxantrone hydrochloride INJECTABLE;INJECTION 019297-002 Dec 23, 1987 4,820,738 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Emd Serono Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 132020000000034 Italy ⤷  Try for Free PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1730131 C01730131/02 Switzerland ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2498758 16/2020 Austria ⤷  Try for Free PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113
1412357 PA2008013,C1412357 Lithuania ⤷  Try for Free PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1412357 C 2008 016 Romania ⤷  Try for Free PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1412357 77 5006-2008 Slovakia ⤷  Try for Free PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
2498758 122020000018 Germany ⤷  Try for Free PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: EMD Serono – Market Position, Strengths & Strategic Insights

Last updated: February 12, 2025

In the ever-evolving pharmaceutical industry, EMD Serono has established itself as a formidable player, leveraging its rich history and innovative approach to carve out a significant market position. As we delve into the competitive landscape surrounding this biopharmaceutical powerhouse, we'll uncover the strengths, strategies, and market dynamics that define EMD Serono's place in the industry.

The EMD Serono Legacy

EMD Serono, the biopharmaceutical arm of Merck KGaA, Darmstadt, Germany, boasts a legacy that spans over three centuries. This rich history has been instrumental in shaping the company's identity and approach to pharmaceutical development[1].

A Heritage of Innovation

Founded in 1668, EMD Serono's parent company, Merck KGaA, holds the distinction of being the world's oldest pharmaceutical and chemical company[1]. This longevity speaks volumes about the company's ability to adapt, innovate, and remain relevant in an industry characterized by rapid change and technological advancements.

The EMD Brand in North America

In the United States and Canada, the company operates under the EMD brand, a nod to its German roots. The name EMD stands for Emmanuel Merck, Darmstadt, highlighting the company's connection to its founding family and original location[1].

Market Position and Core Focus Areas

EMD Serono has carved out strong market positions in several key therapeutic areas, demonstrating its commitment to addressing critical healthcare needs.

Neurology

The company has established a significant presence in the field of neurology, with a particular focus on multiple sclerosis (MS)[1]. This commitment is evident in their research efforts and product portfolio dedicated to improving the lives of patients with neurological conditions.

Endocrinology

EMD Serono's expertise extends to the field of endocrinology, where they have developed treatments for various hormonal disorders[1]. This focus area aligns with the company's mission to address complex medical challenges.

Reproductive Health

Another cornerstone of EMD Serono's market position is its strong presence in reproductive health[1]. The company has made significant strides in developing treatments and technologies to address infertility and other reproductive health issues.

Emerging Focus: Oncology and Immunology

In addition to its established areas of expertise, EMD Serono has demonstrated an enduring commitment to expanding its reach. The company is actively developing new therapies in oncology, immuno-oncology, and immunology, showcasing its ambition to solve previously intractable medical challenges[1].

EMD Serono's Market Share and Financial Performance

EMD Serono's market presence is substantial, with a notable share in key therapeutic areas.

Fertility Treatment Market

EMD Serono boasts of 9.2% market share in the fertility treatment market[2].

This significant market share underscores the company's strong position in reproductive health and its ability to meet the needs of patients and healthcare providers in this specialized field.

Overall Financial Performance

While specific revenue figures for EMD Serono are not provided in the search results, its parent company, Merck KGaA, reported impressive financial results:

  • Revenue at the fiscal year-end 2018: $24,358 million
  • By the third quarter of 2019, revenue exceeded $24 billion
  • Market value: $131,817.8 million
  • Sales growth: 16.45%[2]

These figures indicate the overall financial health and growth trajectory of the parent company, which directly impacts EMD Serono's operations and market position.

Strengths and Competitive Advantages

EMD Serono's market position is bolstered by several key strengths that set it apart in the competitive pharmaceutical landscape.

Research and Development Prowess

One of EMD Serono's major strengths lies in its robust research and development capabilities. In 2018, the company invested €2.2 billion ($2.42 billion) in R&D[2]. This substantial investment underscores the company's commitment to innovation and its ability to develop cutting-edge therapies.

Diverse Product Portfolio

EMD Serono offers a wide range of products and services across diverse industries[2]. This diversification not only provides multiple revenue streams but also allows the company to leverage expertise across different therapeutic areas.

Global Presence

The company has been expanding its global footprint, with new bases established in China and the US[2]. This international expansion enhances EMD Serono's ability to serve patients worldwide and tap into emerging markets.

Quality and Reputation

EMD Serono has built a strong reputation as a provider of high-quality products and services[2]. This reputation is a valuable asset in an industry where trust and reliability are paramount.

Innovative Solutions

The company offers innovative solutions across lab technologies, therapeutics, connectivity, and services[2]. This holistic approach to healthcare solutions positions EMD Serono as a comprehensive partner for healthcare providers and patients alike.

Strategic Insights and Future Outlook

EMD Serono's strategic direction and future outlook are shaped by several key factors and initiatives.

Focus on Patient-Centric Approach

The company's commitment to improving patients' lives is evident in its approach to product development and support services. An estimated 2 million people have been helped through EMD Serono's patient support services[7]. This focus on patient outcomes and experiences is likely to remain a cornerstone of the company's strategy.

Emphasis on Digital Transformation

EMD Serono has been investing in digital technologies to enhance its operations and patient care. As Eduardo, a company representative, states:

"At EMD Serono, we focus on our patients, and we in IT always make sure our systems are robust, secure and modern, to safeguard this important work[5]."

This commitment to digital transformation is crucial in an increasingly technology-driven healthcare landscape.

Continued Investment in R&D

With its significant investment in research and development, EMD Serono is well-positioned to continue developing innovative therapies. The company aims to transform research into first-in-class and best-in-class medicines by doubling its R&D productivity in oncology, neurology, and immunology[7].

Expansion of Product Pipeline

EMD Serono has been actively expanding its product pipeline. Since 2017, the company has received 6 FDA approvals[7]. This track record of regulatory success bodes well for the company's future growth and market position.

Strategic Partnerships

EMD Serono's collaboration with partners like Model N for revenue management demonstrates its strategic approach to leveraging external expertise[5]. Such partnerships are likely to play a crucial role in the company's future growth and operational efficiency.

Competitive Landscape

While EMD Serono holds a strong position in the pharmaceutical industry, it faces competition from other major players.

Key Competitors

Major pharmaceutical companies such as Pfizer, Johnson & Johnson, and Novartis are among EMD Serono's primary competitors[3]. These companies constantly challenge EMD Serono's market share, driving the need for continuous innovation and strategic positioning.

Competitive Pressures

The pharmaceutical industry is characterized by intense competition, particularly in areas such as:

  1. Patent expirations
  2. Pricing pressures
  3. Regulatory challenges
  4. Race for breakthrough therapies

EMD Serono must navigate these challenges while maintaining its market position and pursuing growth opportunities.

SWOT Analysis

A brief SWOT analysis provides further insights into EMD Serono's position in the competitive landscape.

Strengths

  • Strong brand reputation
  • Extensive research capabilities
  • Diverse product portfolio
  • Global presence
  • Patient-centric approach

Weaknesses

  • Patent expirations
  • Regulatory challenges
  • Annual increase in energy consumption (potential environmental concern)[2]

Opportunities

  • Emerging markets
  • Development of breakthrough therapies
  • Digital health innovations
  • Expansion in oncology and immunology

Threats

  • Increasing competition
  • Pricing pressures
  • Regulatory changes
  • Economic uncertainties

Key Takeaways

  1. EMD Serono, with its rich heritage and innovative approach, has established a strong market position in neurology, endocrinology, and reproductive health.

  2. The company's significant investment in R&D ($2.42 billion in 2018) underscores its commitment to innovation and developing cutting-edge therapies.

  3. EMD Serono holds a 9.2% market share in the fertility treatment market, demonstrating its strength in reproductive health.

  4. The company's patient-centric approach, evidenced by its support services that have helped an estimated 2 million people, is a key differentiator.

  5. EMD Serono's focus on digital transformation and strategic partnerships positions it well for future growth and operational efficiency.

  6. While facing competition from major pharmaceutical companies, EMD Serono's diverse product portfolio and global presence provide a solid foundation for continued success.

  7. The company's expansion into oncology and immunology presents significant growth opportunities, aligning with its mission to address complex medical challenges.

FAQs

  1. What is EMD Serono's market share in the fertility treatment market? EMD Serono holds a 9.2% market share in the fertility treatment market.

  2. How much did EMD Serono invest in R&D in 2018? In 2018, EMD Serono invested €2.2 billion ($2.42 billion) in research and development.

  3. What are EMD Serono's core focus areas? EMD Serono's core focus areas include neurology, endocrinology, reproductive health, and emerging focus on oncology and immunology.

  4. How many FDA approvals has EMD Serono received since 2017? EMD Serono has received 6 FDA approvals since 2017.

  5. What is the significance of the EMD brand name in North America? In the United States and Canada, the company operates under the EMD brand, which stands for Emmanuel Merck, Darmstadt, reflecting its German roots and connection to its founding family.

Sources cited:

  1. https://www.massbio.org/members/emd-serono-inc/
  2. https://fidelmanco.com/wp-content/uploads/2023/03/Fidelman_Research_Report_US-Fertility-Treatment-Market-Size.pdf
  3. https://pitchgrade.com/companies/merck
  4. https://technologymagazine.com/company-reports/aspiring-to-create-improve-and-prolong-life-at-emd-serono
  5. https://www.emdserono.com/us-en/company/who-we-are.html

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