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Last Updated: January 29, 2026

Msd Sub Merck Company Profile


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Summary for Msd Sub Merck
International Patents:505
US Patents:18
Tradenames:13
Ingredients:11
NDAs:14

Drugs and US Patents for Msd Sub Merck

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes 9,439,901 ⤷  Get Started Free ⤷  Get Started Free
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 AB RX Yes No 7,326,708*PED ⤷  Get Started Free Y ⤷  Get Started Free
Msd Sub Merck INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 021337-001 Nov 21, 2001 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Msd Sub Merck ZEPATIER elbasvir; grazoprevir TABLET;ORAL 208261-001 Jan 28, 2016 RX Yes Yes 8,871,759 ⤷  Get Started Free Y Y ⤷  Get Started Free
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes 7,326,708*PED ⤷  Get Started Free Y ⤷  Get Started Free
Msd Sub Merck BRIDION sugammadex sodium SOLUTION;INTRAVENOUS 022225-001 Dec 15, 2015 AP RX Yes Yes RE44733*PED ⤷  Get Started Free Y ⤷  Get Started Free
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No 7,326,708*PED ⤷  Get Started Free Y ⤷  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 Msd Sub Merck

Paragraph IV (Patent) Challenges for MSD SUB MERCK drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 1 g/vial ➤ Subscribe 2013-06-20
➤ Subscribe Ophthalmic Solution 2% ➤ Subscribe 2005-10-11
➤ Subscribe Extended-release Tablets 100 mg/1000 mg ➤ Subscribe 2012-10-22
➤ Subscribe Injection 2 mg/mL, 10 mL vial ➤ Subscribe 2008-09-30
➤ Subscribe Injection 0.75 mg/mL, 100 mL vial ➤ Subscribe 2009-06-05
➤ Subscribe Tablets 400 mg ➤ Subscribe 2011-10-12
➤ Subscribe Extended-release Capsules 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe 2012-03-16
➤ Subscribe Tablets 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe 2010-10-18
➤ Subscribe Injection 2 mg/mL, 100 mL vial ➤ Subscribe 2008-12-18

Supplementary Protection Certificates for Msd Sub Merck Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2410844 CR 2016 00069 Denmark ⤷  Get Started Free PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
2310095 PA2016049,C2310095 Lithuania ⤷  Get Started Free PRODUCT NAME: GRAZOPREVIRAS ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1119 20160722
2310095 2017/002 Ireland ⤷  Get Started Free PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1119 20160722
1259550 SPC/GB08/057 United Kingdom ⤷  Get Started Free PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
2334687 PA2018510 Lithuania ⤷  Get Started Free PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321
0579826 SPC/GB02/042 United Kingdom ⤷  Get Started Free PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
2498758 2090013-0 Sweden ⤷  Get Started Free PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: MSD SUB MERCK – Market Position, Strengths & Strategic Insights

Last updated: December 29, 2025


Executive Summary

MSD (known as Merck & Co. in the United States and Canada) stands as a global pharmaceutical leader with a robust portfolio spanning oncology, vaccines, infectious diseases, and specialty therapies. This analysis evaluates MSD’s market positioning, core strengths, recent strategic initiatives, and competitive landscape. It highlights its differentiation factors, challenges, and opportunities amidst a dynamic industry driven by innovation, regulatory complexities, and shifting market demands.

Key Highlights:

  • Market Position: MSD maintains a top-tier position among global pharmaceutical giants, consistently ranking within the top five R&D spenders and revenue generators.
  • Core Strengths: Innovative R&D pipeline, extensive vaccine portfolio, strategic partnerships, and a resilient global distribution network.
  • Strategic Focus: Emphasizes personalized medicine, biosimilars, and expanding access in emerging markets.
  • Competitive Challenges: Patent expirations, pricing pressures, and intensifying competition from biotechs and generics.

What Is MSD’s Current Market Position and Competitive Standing?

Global Market Share & Revenue Breakdown

Region Market Share (Approximate) Revenue (2022) Key Products & Focus Areas
North America 35% – 40% ~$21.7B Oncology (Keytruda), Vaccines (Gardasil), Diabetes
Europe 20% – 25% ~$12.5B Oncology, Vaccines, Infectious Diseases
Emerging Markets 15% – 20% ~$9.2B Infectious, Vaccines, Specialty Care
Others (Asia, RoW) 15% ~$4.8B Vaccines, Generics, Biosimilars

Source: MSD Annual Reports 2022, IQVIA Data

Positioning among peers:

  • In 2022, MSD ranked among the top five global pharmaceutical companies by revenue, competing with Pfizer, Roche, Novartis, and Johnson & Johnson.
  • Keytruda (pembrolizumab) remains a dominant revenue driver, accounting for approximately 15% of total sales.

Market Competitive Edge

  • Pipeline Strength: Over 100 projects in clinical development, with a strong focus on oncology, immunology, and vaccines.
  • Vaccine Leadership: Gardenress (HPV vaccine) and renewed focus on COVID-19 vaccine development showcase resilience.
  • Innovation & R&D Investment: Spent ~$12B in 2022, representing 18% of total revenue, emphasizing commitment to breakthroughs.

What Are MSD’s Core Strengths That Drive Its Strategic Advantage?

1. Robust R&D Pipeline and Innovation

Indicator Details
R&D Spend (2022) ~$12B (18% of revenue)
Pipeline Nodes 120+ active projects, 50+ in late-stage trials
Key Focus Areas Oncology (immune checkpoint inhibitors, CAR-T), Vaccines, Rare Diseases

Example:

  • Keytruda’s (pembrolizumab) expanding indications across multiple cancers enhances revenue stability.
  • Development of Lenvima (lenvatinib) combined therapies demonstrates versatility in oncology.

2. Leading Vaccine Portfolio and Public Health Engagement

Vaccine Products Indications Market Penetration
Gardasil HPV-related cancers Dominant in mature markets
Pneumovax Pneumococcal diseases Widespread use worldwide
Vaccine Innovation mRNA and recombinant technology Pioneering efforts in COVID-19 vaccines

3. Strategic Collaborations & Licensing Agreements

  • MSD leverages alliances with biotech startups, universities, and governments to accelerate innovation.
  • Recent collaborations include partnerships with BioNTech for mRNA technology and Moderna for vaccine development.

4. Global Manufacturing & Distribution Infrastructure

Facility Count 60+ manufacturing plants worldwide
Distribution Reach 150+ countries, ensuring access in emerging markets
Supply Chain Resilience Focus on agility and digital tracking

5. Market Diversification

  • Balances portfolio with core therapeutic areas and geographical presence to mitigate risks associated with regulatory and patent challenges.

What Strategic Initiatives Are Shaping MSD’s Future?

1. Focus on Personalized Medicine & Biosimilars

Initiative Description
Precision Oncology Investment in targeted therapies, companion diagnostics
Biosimilar Development Entry into biosimilars market with Ontruzant (trastuzumab) and others

2. Expansion in Emerging Markets

  • Pledges increased investments and tailored pricing models to improve access in Africa, Asia, and Latin America.
  • Example: Local manufacturing plants in India, China, and Brazil contribute to market penetration.

3. Digital Transformation & Data Analytics

  • Implementing AI/ML tools to optimize R&D, accelerate clinical trials, and enhance supply chain visibility.
  • Adoption of real-world evidence (RWE) to support regulatory submissions and payer negotiations.

4. Commitment to Sustainability & Access

  • Goals include reducing carbon footprint (~50% reduction by 2030) and enhancing access initiatives through alliances with WHO and GAVI.

How Does MSD Compare to Major Competitors?

Benchmarking Table: Key Metrics (2022)

Company Revenue (USD B) R&D Spend (USD B) Key Products Market Focus
MSD ~$58.3 ~$12 Keytruda, Gardasil, Lenvima Oncology, Vaccines, Infectious Diseases
Pfizer ~$100.3 ~$13.8 Comirnaty, Ibrance Vaccines, Oncology
Roche ~$63.3 ~$9.6 Herceptin, Avastin Oncology, Diagnostics
Novartis ~$51.9 ~$9.3 Cosentyx, Zolgensma Oncology, Biosimilars
J&J ~$54.7 ~$12 Stelara, Janssen vaccines Immunology, Consumer Healthcare

Sources: Company Annual Reports 2022, Evaluate Pharma, IQVIA

Key Differentiators

  • MSD’s Keytruda is leading the immuno-oncology market.
  • Significant investments in vaccine innovation serve as a competitive advantage, especially amidst the global COVID-19 response.
  • Focused expansion into biosimilars uniquely positions MSD for growth as originator patents expire.

What Are the Challenges and Risks Faced by MSD?

1. Patent Expirations & Generic Competition

  • Patent cliffs for blockbuster drugs like Remicade (adalimumab) threaten revenue streams.
  • Increased biosimilar competition diminishes market exclusivity.

2. Pricing & Reimbursement Pressures

  • Governments and payers worldwide push for lower drug prices, especially for high-cost therapies.
  • Impacted especially in Europe and the U.S.

3. Regulatory & Political Risks

  • Stringent regulation in emerging markets.
  • Potential restrictions or delays due to geopolitical tensions.

4. Scientific & Technological Uncertainties

  • R&D success rates are inherently uncertain.
  • Competition from innovative biotech firms with disruptive technologies.

What Are the Strategic Opportunities for MSD Moving Forward?

1. Investment in Cell & Gene Therapies

  • Capitalize on advancements in gene editing (e.g., CRISPR) and personalized cellular treatments.

2. Accelerate Adoption of Digital Health Solutions

  • Use real-world data to inform clinical and commercial strategies.
  • Enhance remote trials and telemedicine integration.

3. Expand Access & Affordability Programs

  • Partner with global health entities.
  • Develop tiered pricing models and local manufacturing.

4. Strengthen Portfolio in Rare Diseases & Unmet Needs

  • Focus on rare cancers, genetic disorders, & infectious diseases like tuberculosis and HIV.

Conclusion and Key Takeaways

  • MSD’s dominant market position hinges on a strong R&D pipeline, portfolio diversification, and strategic innovation.
  • Its leadership in oncology (via Keytruda), vaccines (Gardasil), and infectious diseases maintains a competitive edge.
  • Ongoing investments in biosimilars, personalized medicine, and emerging markets are crucial for future growth.
  • Challenges such as patent expiry, pricing pressures, and regulatory hurdles necessitate agile strategic responses.
  • Embracing digital transformation and patient-centric approaches will catalyze MSD’s sustained competitive advantage.

FAQs

1. How does MSD's pipeline compare to its competitors?

MSD’s pipeline is among the strongest, with over 120 active projects, especially in immuno-oncology and vaccines. Its focus on personalized medicine and biotherapeutics sets it apart from peers like Pfizer and Roche.

2. What is the significance of Keytruda for MSD’s market position?

Keytruda remains MSD’s flagship revenue driver, accounting for 15% of total sales (2022). It is a leader in immune checkpoint inhibitors with multiple approved indications, reinforcing MSD’s leadership in oncology.

3. How is MSD expanding its presence in emerging markets?

MSD invests in local manufacturing, licensing agreements, and tailored access programs in Africa, Asia, and Latin America to increase market penetration and improve affordability.

4. What are the primary risks facing MSD in the near future?

Patent expirations, biosimilar competition, pricing pressures, and geopolitical/regulatory risks pose significant challenges. The company plans to address these via pipeline diversification and market expansion.

5. What strategic initiatives will most impact MSD’s future growth?

Focus on biosimilars, personalized medicine, digital innovation, and emerging markets will be vital. Collaborations with biotech firms and investments in gene and cell therapy will deepen innovation capabilities.


References

  1. MSD Annual Reports 2022
  2. IQVIA Data 2022
  3. Evaluate Pharma Market Data 2022
  4. Company Press Releases & Strategic Reports

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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.