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Last Updated: July 28, 2025

Merck Sharp Dohme Company Profile


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Summary for Merck Sharp Dohme
International Patents:388
US Patents:17
Tradenames:18
Ingredients:18
NDAs:22

Drugs and US Patents for Merck Sharp Dohme

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No 7,754,731*PED ⤷  Try for Free Y ⤷  Try for Free
Merck Sharp Dohme PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER famotidine INJECTABLE;INJECTION 020249-001 Feb 18, 1994 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Merck Sharp Dohme VICTRELIS boceprevir CAPSULE;ORAL 202258-001 May 13, 2011 DISCN No No 8,119,602 ⤷  Try for Free ⤷  Try for Free
Merck Sharp Dohme WELIREG belzutifan TABLET;ORAL 215383-001 Aug 13, 2021 RX Yes Yes RE49948 ⤷  Try for Free Y Y ⤷  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
Showing 1 to 4 of 4 entries

Expired US Patents for Merck Sharp Dohme

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 7,214,683*PED ⤷  Try for Free
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-002 Oct 7, 2011 6,303,661 ⤷  Try for Free
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 6,063,772*PED ⤷  Try for Free
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-002 Jul 25, 2001 6,337,090*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries
Paragraph IV (Patent) Challenges for MERCK SHARP DOHME drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg ➤ Subscribe 2012-11-06
➤ Subscribe Capsules 140 mg and 180 mg ➤ Subscribe 2008-03-24
➤ Subscribe Delayed-release Tablets 100 mg ➤ Subscribe 2014-06-16
➤ Subscribe Tablets 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Tablets 25 mg, 50 mg and 100 mg ➤ Subscribe 2010-10-18
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-25
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe 2011-02-28
➤ Subscribe Injection 18 mg/mL, 16.7 mL vials ➤ Subscribe 2015-11-24
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-19

Supplementary Protection Certificates for Merck Sharp Dohme Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1622880 122018000080 Germany ⤷  Try for Free PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108
1622880 300933 Netherlands ⤷  Try for Free PRODUCT NAME: LETERMOVIR; REGISTRATION NO/DATE: EU/1/17/1245 20180110
1412357 C300287 Netherlands ⤷  Try for Free PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1412357 C300357 Netherlands ⤷  Try for Free PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries
Similar Applicant Names
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Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Merck Sharp & Dohme – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025


Introduction

Merck Sharp & Dohme (MSD), known as Merck & Co. in the United States and Canada, stands as a formidable player within the global pharmaceutical industry. With a legacy spanning over a century, MSD’s strategic initiatives, robust product pipeline, and innovation-driven approach have cemented its reputation as a leading innovator in therapeutics, vaccines, and biologics. This report evaluates MSD’s current market position, core strengths, competitive landscape, and strategic growth avenues to enable stakeholders to make informed decisions.


Market Position of MSD in the Global Pharmaceutical Industry

Market Leadership and Revenue Performance

MSD consistently ranks among the top global pharmaceutical companies by revenue. In 2022, the company's global sales surpassed $59 billion, making it one of the industry's largest players alongside Pfizer, Johnson & Johnson, and Roche [1]. Its portfolio spans infectious diseases, oncology, cardiovascular, and immunology, providing diversified revenue streams and mitigating risks associated with dependence on a single therapeutic area.

Geographical Footprint

MSD maintains a broad geographical presence, with significant markets in North America, Europe, Asia-Pacific, and emerging markets. North America remains its largest contributor, driven by high healthcare expenditure and favorable reimbursement policies, whereas growth in emerging markets offers significant long-term potential due to increasing healthcare access and infrastructure development [2].

Research & Development (R&D) Investment

With annual R&D expenditure exceeding $10 billion, MSD invests heavily in innovation, ranking among the top global R&D spenders [3]. Its focus includes immunooncology, precision medicine, and vaccine development, positioning it favorably against competitors that are similarly committed to R&D.

Patent Portfolio and Product Lifecycle

MSD’s strategic licensing and patent protections provide competitive advantages—particularly in blockbuster drugs like Keytruda (pembrolizumab) and Gardasil (HPV vaccine). The expiry of key patents is a significant concern; however, the company's pipeline aims to offset this risk through novel and biosimilar offerings.


Core Strengths Driving MSD’s Competitive Advantage

1. Innovative Portfolio and Therapeutic Leadership

MSD boasts a strong pipeline anchored by blockbuster therapeutics such as Keytruda, a pioneer in cancer immunotherapy, which earned over $17 billion in revenue in 2022 [4]. Its leadership in vaccine development, especially the HPV vaccine Gardasil, provides a competitive moat, complemented by its leadership in infectious disease therapeutics.

2. Robust R&D Capabilities and Scientific Expertise

The company’s advanced R&D infrastructure and collaborations with academia accelerate drug discovery and development processes. Its focus on personalized medicine and biologics positions MSD at the forefront of therapeutic innovation.

3. Strategic Collaborations and Licensing Agreements

Partnerships with biotech firms, academic institutions, and governments enhance its innovation scope and market reach. Notable collaborations include AstraZeneca, with whom MSD co-developed Lynparza (olaparib), and efforts to expand vaccine access globally.

4. Strong Manufacturing and Supply Chain

MSD’s established manufacturing infrastructure ensures consistent product quality and supply chain resilience, a critical factor amid global disruptions caused by the COVID-19 pandemic.

5. Market Access and Commercial Excellence

MSD’s extensive commercial network and early engagement with healthcare providers facilitate faster adoption of new therapies and vaccines. Its pricing strategies balance affordability with profitability, especially in emerging markets.


Strategic Insights and Future Outlook

1. Emphasis on Immuno-Oncology and Precision Medicine

The success of Keytruda exemplifies MSD’s mastery within immuno-oncology. Future growth hinges on expanding the indication spectrum and embracing biomarkers for personalized therapies, which promise higher efficacy and market differentiation.

2. Expanding Vaccine Portfolio & Global Immunization Initiatives

Vaccines constitute a pivotal growth area, with investments in mRNA technologies and regional vaccination programs. MSD’s partnerships with Gavi and other entities underline a strategy to expand its influence in global immunization efforts.

3. Integration of Digital Health and Data Analytics

Adopting digital tools for clinical trials, real-world evidence collection, and patient engagement offers efficiencies and enhanced drug development insights. Aligning with digital health trends will augment MSD’s innovation pipeline and market responsiveness.

4. Biosimilar and Specialty Drug Development

In response to patent expirations and market demands, MSD is increasingly focusing on biosimilars and specialty drugs. This diversification aims to offset revenue dips and capture emerging market opportunities.

5. Navigating Regulatory and Market Access Challenges

Complex regulatory landscapes and pricing pressures necessitate proactive engagement with policymakers. Customized strategies tailored to regional healthcare policies will be instrumental in safeguarding profitability.


Competitive Landscape Overview

MSD’s key competitors include Pfizer, Roche, Johnson & Johnson, AstraZeneca, and Bayer. While each possesses distinct strengths, MSD’s focused pipeline, especially in immunotherapy and vaccines, gives it a competitive edge. Nonetheless, patent expirations and patent cliffs present ongoing challenges, emphasizing the need for sustained innovation.

Comparison Highlights:

  • Pfizer: Dominant in vaccines and recently in COVID-19 therapeutics; aggressive in M&A activities.
  • Roche: Leader in oncology with a strong diagnostics presence.
  • Johnson & Johnson: Diversified across pharmaceuticals, medical devices, and consumer health.
  • AstraZeneca: Strong vaccine and oncology portfolio, with recent success in respiratory therapeutics.
  • Bayer: Focused on specialty pharmaceuticals and consumer health sectors.

Strategic Recommendations

  • Invest in Next-Generation Immunotherapies: Prioritize research in combination therapies and biomarker-driven treatments to sustain leadership in oncology.
  • Global Expansion in Emerging Markets: Leverage existing regional partnerships to increase vaccine and drug access, capturing unmet medical needs.
  • Enhance Digital and Data-driven Innovation: Integrate AI and real-world data analytics into R&D to accelerate drug discovery and personalized treatment options.
  • Diversify Revenue Streams: Continue developing biosimilars and specialty drugs to offset patent expiries and enhance profitability.
  • Strengthen Public-Private Partnerships: Collaborate with governments and NGOs to boost global health initiatives, especially in infectious diseases and vaccines.

Key Takeaways

  • Market Leadership: MSD’s diversified global portfolio, with flagship products like Keytruda and Gardasil, solidifies its dominating industry position.
  • Innovation Focus: Heavy investment in R&D and strategic collaborations underpin long-term growth prospects.
  • Pipeline Strength: A robust pipeline emphasizing immuno-oncology, vaccines, and biologics positions MSD ahead in therapeutic innovation.
  • Growth Opportunities: Emerging markets, biosimilars, and digital health adoption represent key avenues for expansion.
  • Challenges & Risks: Patent expiries, regulatory complexities, and mounting pricing pressures necessitate strategic agility.

FAQs

1. How does MSD differentiate itself in the competitive pharmaceutical landscape?
MSD leverages its leadership in immuno-oncology, vaccines, and biologics, supported by substantial R&D investment and strategic collaborations, to maintain a competitive edge.

2. What are the primary growth drivers for MSD in the coming years?
Key drivers include expanding its immuno-oncology portfolio (notably Keytruda), vaccine innovations, growth in emerging markets, and development of biosimilars.

3. How vulnerable is MSD to patent expiries of blockbuster drugs?
While patent expiries pose risks, MSD mitigates this through ongoing pipeline development, biosimilar offerings, and diversification into new therapeutic areas.

4. In what regions does MSD see the most potential for market expansion?
Emerging markets in Asia-Pacific, Latin America, and Africa present significant growth potential due to increasing healthcare access and government initiatives.

5. What strategies should MSD pursue to stay ahead of competitors?
Focus on personalized medicine, digital health integrations, expanding vaccine access globally, and robust pipeline management to sustain innovation leadership.


References

[1] IQVIA, "Pharmaceutical Market Reports," 2022.
[2] MSD Annual Report, 2022.
[3] EvaluatePharma, "R&D Spending Trends," 2022.
[4] Merck & Co. Q4 2022 Earnings Call, 2023.

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