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Last Updated: February 17, 2025

Emd Serono Inc Company Profile


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Summary for Emd Serono Inc
International Patents:200
US Patents:13
Tradenames:6
Ingredients:5
NDAs:6
Drug Master File Entries: 2

Drugs and US Patents for Emd Serono Inc

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 GLUCOPHAGE metformin hydrochloride TABLET;ORAL 020357-005 Nov 5, 1998 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 9,284,300 ⤷  Try for Free Y ⤷  Try for Free
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-002 Aug 11, 2000 DISCN Yes No ⤷  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 MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 RX Yes Yes 10,849,919 ⤷  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 Inc

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 7,605,121 ⤷  Try for Free
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 6,660,300 ⤷  Try for Free
Emd Serono Inc GEREF sermorelin acetate INJECTABLE;INJECTION 020443-001 Sep 26, 1997 4,517,181 ⤷  Try for Free
Emd Serono Inc GEREF sermorelin acetate INJECTABLE;INJECTION 020443-002 Sep 26, 1997 4,703,035 ⤷  Try for Free
Emd Serono Inc CETROTIDE cetrorelix acetate POWDER;SUBCUTANEOUS 021197-001 Aug 11, 2000 7,605,121 ⤷  Try for Free
Emd Serono Inc MAVENCLAD cladribine TABLET;ORAL 022561-001 Mar 29, 2019 7,888,328 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Emd Serono Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2164843 28/2022 Austria ⤷  Try for Free PRODUCT NAME: TEPOTINIB UND PHARMAZEUTISCH VERWENDBARE SOLVATE, SALZE, TAUTOMERE UND STEREOISOMERE DAVON; REGISTRATION NO/DATE: EU/1/21/1596 (MITTEILUNG) 20220217
1506211 C01506211/02 Switzerland ⤷  Try for Free PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357 50/2008 Austria ⤷  Try for Free PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1506211 132014902277722 Italy ⤷  Try for Free PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
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
2498758 301040 Netherlands ⤷  Try for Free PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Emd Serono Inc Market Analysis and Financial Projection

Pharmaceutical Competitive Landscape Analysis: EMD Serono Inc – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, understanding the competitive landscape is crucial for success. EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, has established itself as a significant player in the biopharmaceutical sector. Let's dive into an in-depth analysis of EMD Serono's market position, strengths, and strategic insights.

EMD Serono: A Brief Overview

EMD Serono is a specialized biopharmaceutical company dedicated to developing groundbreaking therapies. With a rich history dating back to the oldest pharmaceutical and chemical company in the world, EMD Serono has carved out a niche for itself in the US market[1].

Market Position and Core Focus Areas

EMD Serono has strategically positioned itself in several key therapeutic areas:

Neurology

The company has established strong market positions in neurology, particularly in multiple sclerosis (MS) treatment[2]. Their commitment to this field is evident in their ongoing research and development efforts.

Endocrinology

EMD Serono has a significant presence in the endocrinology market, offering treatments for various hormonal disorders[2].

Reproductive Health

The company maintains a robust portfolio in reproductive health, addressing fertility issues and related conditions[2].

Oncology and Immuno-oncology

EMD Serono is actively expanding its presence in oncology and immuno-oncology, with a focus on developing innovative cancer therapies[1].

Immunology

The company is investing in immunology research, aiming to develop new treatments for autoimmune and inflammatory diseases[1].

Strengths and Competitive Advantages

Strong R&D Capabilities

EMD Serono's commitment to research and development is a key strength. The company has invested significantly in state-of-the-art research facilities, particularly in Massachusetts[1].

Global Research Network

With four global R&D hubs in Boston, Darmstadt, Beijing, and Tokyo, EMD Serono leverages a diverse pool of talent and resources[1].

Strategic Partnerships

The company has demonstrated a willingness to collaborate with other industry leaders. For instance, their research agreement with Pfizer and the Broad Institute showcases their commitment to advancing scientific knowledge[4].

Patient-Centric Approach

EMD Serono's focus on specialty care and commitment to improving patients' lives sets them apart in the competitive landscape[8].

Market Expansion and Growth Strategies

US Market Focus

EMD Serono has been actively expanding its presence in the United States, recognizing it as one of the fastest-growing markets[1].

Investment in Infrastructure

The company has invested over $75 million in a new state-of-the-art research facility in Massachusetts, signaling its long-term commitment to the US market[1].

Talent Acquisition

EMD Serono's expansion plans include a significant increase in its employee base, particularly in the Boston area[1].

Product Portfolio and Pipeline

Key Products

EMD Serono's product portfolio includes notable drugs such as:

  • Rebif (for multiple sclerosis)
  • Mavenclad (for multiple sclerosis)
  • Erbitux (for colorectal and head and neck cancers)
  • Bavencio (for various cancers)[7]

Pipeline Development

The company is actively developing new therapies, with a particular focus on oncology, immuno-oncology, and immunology[1].

Competitive Landscape and Market Challenges

Industry Competition

EMD Serono faces stiff competition from other major pharmaceutical companies in its core therapeutic areas. Companies like Novartis, Pfizer, and Biogen are key competitors in the neurodegenerative drugs market[9].

Regulatory Challenges

As with all pharmaceutical companies, EMD Serono must navigate complex regulatory landscapes, particularly in the US market[6].

Patent Expirations

Managing patent lifecycles and developing new products to offset revenue losses from patent expirations is an ongoing challenge[3].

Strategic Initiatives and Future Outlook

Focus on Specialty Care

EMD Serono continues to emphasize its specialty care focus, positioning itself as one of the top five US biopharmaceutical companies exclusively focused on this area[8].

Expansion of Immuno-oncology Platform

The company is heavily investing in its immuno-oncology (iONC) platform, with a unique strategy centered on three innovation clusters: therapeutic cancer vaccines, cancer stem cells, and tumor immunotolerance[8].

Digital Transformation

EMD Serono is leveraging digital technologies to enhance its operations. Their partnership with Model N for revenue management is an example of this digital focus[5].

Financial Performance and Market Share

While specific financial data for EMD Serono is not readily available, the overall performance of Merck KGaA's healthcare division provides insights:

  • In 2023, the Healthcare division generated 38% of Merck Group sales and 41% of EBITDA pre (excluding Corporate and Other)[10].
  • Europe and North America accounted for 53% of Healthcare's net sales in 2023[10].
  • The company has been expanding its presence in growth markets, with Asia-Pacific and Latin America accounting for 40% of sales in 2023[10].
"The US represents one of the fastest growing markets for our company. Strengthening our presence in the US is central to our ability to deliver innovation and value to our patients and customers." - Annalisa Jenkins, Head of Global Drug Development and Medical[1]

Key Takeaways

  • EMD Serono has established strong market positions in neurology, endocrinology, and reproductive health, with growing focus on oncology and immunology.
  • The company's commitment to R&D, global research network, and strategic partnerships are key competitive advantages.
  • EMD Serono is actively expanding its presence in the US market through infrastructure investments and talent acquisition.
  • The company's focus on specialty care and patient-centric approach differentiates it in the competitive landscape.
  • EMD Serono faces challenges from industry competition, regulatory requirements, and patent expirations.
  • Future strategies include expanding the immuno-oncology platform and leveraging digital transformation.

FAQs

  1. What are EMD Serono's main therapeutic areas? EMD Serono focuses primarily on neurology, endocrinology, reproductive health, oncology, and immunology.

  2. How is EMD Serono expanding its presence in the US market? The company is investing in research facilities, increasing its employee base, and focusing on strategic partnerships in the US.

  3. What sets EMD Serono apart from its competitors? EMD Serono's focus on specialty care, strong R&D capabilities, and patient-centric approach are key differentiators.

  4. What are some of EMD Serono's key products? Notable products include Rebif and Mavenclad for multiple sclerosis, Erbitux for certain cancers, and Bavencio for various cancers.

  5. What future strategies is EMD Serono pursuing? The company is focusing on expanding its immuno-oncology platform, digital transformation, and continued investment in specialty care areas.

Sources cited: [1] https://www.businesswire.com/news/home/20130418005235/en/EMD-Serono-Expands-Global-Research-Development-Hub-in-Massachusetts-and-Continues-to-Build-Presence-in-US-Pharmaceuticals-Market [2] https://www.massbio.org/members/emd-serono-inc/ [3] https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/ [4] https://www.emdserono.com/us-en/press-archives/emd-serono-press-releases-2014.pdf [5] https://technologymagazine.com/company-reports/aspiring-to-create-improve-and-prolong-life-at-emd-serono [7] https://en.wikipedia.org/wiki/Merck_Serono [8] https://www.lifescienceleader.com/doc/emd-serono-the-culture-of-specialty-care-0001 [9] https://central.newschannelnebraska.com/story/51721644/new-neurodegenerative-drugs-market-analysis-leading-players-and-future-forecast-2024-2032 [10] https://www.emdgroup.com/investors/reports-and-financials/earnings-materials/2023-q4/us/2023-Single-Entity-Report-NA.pdf

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