Merck Sharp Dohme Company Profile

What is the competitive landscape for MERCK SHARP DOHME

MERCK SHARP DOHME has twenty-two approved drugs.

There are seventeen US patents protecting MERCK SHARP DOHME drugs.

There are three hundred and eighty-seven patent family members on MERCK SHARP DOHME drugs in fifty-six countries and eighty-eight supplementary protection certificates in eighteen countries.

Summary for Merck Sharp Dohme

International Patents:	387
US Patents:	17
Tradenames:	18
Ingredients:	18
NDAs:	22

Drugs and US Patents for Merck Sharp Dohme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	GUANIDINE HYDROCHLORIDE	guanidine hydrochloride	TABLET;ORAL	001546-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-002	Nov 8, 2017		RX	Yes	Yes
Merck Sharp Dohme	STROMECTOL	ivermectin	TABLET;ORAL	050742-002	Oct 8, 1998	AB	RX	Yes	Yes
Merck Sharp Dohme	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes	RE46791		Y	Y
Merck Sharp Dohme	STROMECTOL	ivermectin	TABLET;ORAL	050742-001	Nov 22, 1996		DISCN	Yes	No
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013		DISCN	Yes	No

Expired US Patents for Merck Sharp Dohme

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-006	Sep 18, 2012	6,890,898
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012	7,459,428
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001	6,461,605*PED
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-003	Oct 7, 2011	8,168,637
Merck Sharp Dohme	CELESTONE	betamethasone	SYRUP;ORAL	014215-002	Approved Prior to Jan 1, 1982	3,485,854
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-004	Aug 11, 1999	5,260,291*PED

Paragraph IV (Patent) Challenges for MERCK SHARP DOHME drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Suspension	40 mg/mL		2011-02-28
	Injection	18 mg/mL, 16.7 mL vials		2015-11-24
	Orally Disintegrating Tablets	2.5 mg and 5 mg		2006-06-21
	Tablets	100 mg/10 mg and 100 mg/40 mg		2012-06-19
	Tablets	50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg		2012-11-06
	Capsules	140 mg and 180 mg		2008-03-24
	Delayed-release Tablets	100 mg		2014-06-16
	Tablets	5 mg		2006-06-21
	Tablets	25 mg, 50 mg and 100 mg		2010-10-18
	Tablets	100 mg/10 mg and 100 mg/40 mg		2012-06-25

International Patents for Merck Sharp Dohme Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3417851
Japan	2019089855
Japan	6387486
Slovenia	1654263
South Korea	20090087110
Honduras	2004000146
Slovenia	2819648

Supplementary Protection Certificates for Merck Sharp Dohme Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1622880	LUC00080	Luxembourg		PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110
1620113	CA 2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
1084705	CR 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
1412357	SPC/GB08/040	United Kingdom		PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Merck
• Merck And Co Inc
• Merck Kgaa
• Merck Sharp Dohme

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

In the ever-evolving world of pharmaceuticals, few names carry as much weight as Merck Sharp & Dohme (MSD). As we delve into the competitive landscape of this industry giant, we'll uncover the key factors that have propelled MSD to its current market position, explore its strengths, and gain valuable strategic insights. Let's embark on this journey through the pharmaceutical realm, where innovation meets business acumen.

The Pharmaceutical Titan: Merck Sharp & Dohme

Merck Sharp & Dohme, known as Merck & Co. in the United States and Canada, stands as a colossus in the global pharmaceutical industry. With a rich history dating back to 1891, MSD has consistently been at the forefront of medical innovation and scientific breakthroughs[4].

A Global Powerhouse

MSD's influence extends far beyond its New Jersey headquarters. The company operates in over 140 countries, leveraging its global footprint to maximize the reach of its products[5]. This international presence is crucial for tapping into emerging markets and ensuring sustainable growth.

"2023 was another very strong year for Merck. I am extremely pleased by the progress we've made to develop and deliver transformative therapies and vaccines that will help save and improve lives around the world. We reached more than 500 million people with our medicines last year alone, over half of which were donations, including through our program to treat river blindness," said Robert M. Davis, chairman and chief executive officer, Merck[1].

MSD's Market Position: A Force to Be Reckoned With

In the fiercely competitive pharmaceutical landscape, MSD has carved out a formidable position for itself. Let's examine the factors that contribute to its market standing.

Revenue and Rankings

As of 2024, MSD ranks fourth among global pharmaceutical companies, with human health division revenues totaling US$53.6 billion, up 3% from the previous year[7]. This impressive performance is a testament to the company's strong product portfolio and strategic focus on key therapeutic areas.

Key Therapeutic Areas

MSD's market position is bolstered by its strong presence in several critical therapeutic areas:

1. Oncology
2. Vaccines
3. Infectious diseases
4. Cardio-metabolic disorders
5. Immunology

The company's diverse portfolio allows it to cater to a wide range of healthcare needs, further solidifying its market position[5].

Strengths That Set MSD Apart

MSD's success isn't accidental. It's the result of several key strengths that give the company a competitive edge in the pharmaceutical industry.

1. Robust Research and Development

At the heart of MSD's success lies its unwavering commitment to research and development (R&D). In 2023, the company invested a staggering $30.5 billion in R&D, including expenditures related to certain business development transactions[2]. This substantial investment fuels innovation and helps maintain MSD's pipeline of promising new treatments.

2. Blockbuster Products

MSD's portfolio includes several blockbuster products that generate significant revenue. The standout performer is Keytruda, an immunotherapy drug that accounted for over 46% of the company's pharmaceutical revenues in 2023, with sales reaching US$25 billion[7].

3. Strong Vaccine Division

MSD's vaccine division is another pillar of strength. Products like Gardasil (HPV vaccine) have shown impressive growth, with sales increasing by 29% in 2023[7].

4. Global Reach and Distribution Network

The company's extensive global presence allows it to reach diverse markets and adapt to regional healthcare needs. This global footprint is a significant asset in an increasingly interconnected world[5].

5. Strategic Partnerships and Collaborations

MSD actively seeks partnerships with academic institutions, biotech firms, and other pharmaceutical companies. These collaborations enhance the company's R&D capabilities and help accelerate the development of new treatments[3].

Strategic Insights: Navigating the Future

As we look towards the future, several strategic insights emerge that will likely shape MSD's trajectory in the coming years.

Diversification Beyond Keytruda

While Keytruda has been a phenomenal success, MSD is keenly aware of the need to diversify its revenue streams. The drug is set to lose market exclusivity in 2028, prompting the company to explore new avenues for growth[7].

Focus on Emerging Markets

Expanding into emerging markets presents a significant opportunity for MSD. These markets often have growing healthcare needs and increasing access to medical treatments, providing fertile ground for expansion.

Embracing Biotechnology

The future of pharmaceuticals is increasingly intertwined with biotechnology. MSD's investments and partnerships in this area suggest a strategic focus on staying at the cutting edge of biotech innovations.

Addressing Global Health Challenges

MSD's commitment to addressing global health challenges, as evidenced by its donations and programs like the one treating river blindness, not only serves a humanitarian purpose but also enhances the company's reputation and global influence[1].

Competitive Landscape: MSD's Rivals

To fully appreciate MSD's position, we must consider its main competitors in the pharmaceutical industry.

1. Pfizer

Pfizer, the industry leader, is known for its extensive portfolio of medicines, vaccines, and consumer healthcare products. Its recent success with the COVID-19 vaccine has further strengthened its market position[5].

2. Johnson & Johnson

Johnson & Johnson's pharmaceutical division, Janssen, develops drugs across various therapeutic areas, making it a significant competitor to MSD[5].

3. Novartis

Novartis focuses on innovative medicines, generics, and eye care products. The company's strong R&D pipeline and strategic acquisitions position it as a key player in the industry[5].

4. Roche

Roche is a global leader in biotechnology and pharmaceuticals, with a strong focus on oncology, immunology, infectious diseases, ophthalmology, and neuroscience[5].

Future Outlook: MSD's Path Forward

As we look to the future, MSD appears well-positioned to maintain its strong market presence. The company's 2025 financial outlook anticipates worldwide sales to be between $64.1 billion and $65.6 billion, reflecting confidence in continued growth[10].

Promising Pipeline

MSD's pipeline remains robust, with several promising candidates in late-stage development. The company initiated more than 20 Phase 3 study starts in 2023, including the progression of eight novel assets into Phase 3[1].

Strategic Acquisitions and Partnerships

MSD continues to augment its pipeline through strategic acquisitions and partnerships. Recent examples include the acquisition of Prometheus and Imago, and collaboration agreements with Daiichi Sankyo and Kelun-Biotech[1].

Key Takeaways

1. MSD maintains a strong market position, ranking fourth among global pharmaceutical companies with revenues of $53.6 billion in 2023.
2. The company's success is driven by its robust R&D investments, blockbuster products like Keytruda, and a strong vaccine division.
3. MSD's global presence and strategic partnerships contribute significantly to its competitive advantage.
4. The company is actively diversifying beyond Keytruda and focusing on emerging markets and biotechnology to drive future growth.
5. MSD's commitment to addressing global health challenges enhances its reputation and influence in the industry.
6. With a promising pipeline and strategic acquisitions, MSD is well-positioned for continued growth in the coming years.

FAQs

1. What is MSD's most successful product? Keytruda, an immunotherapy drug, is currently MSD's most successful product, accounting for over 46% of the company's pharmaceutical revenues in 2023.

2. How much does MSD invest in research and development? In 2023, MSD invested approximately $30.5 billion in research and development, including expenditures related to certain business development transactions.

3. What are MSD's key therapeutic areas? MSD focuses on several key therapeutic areas, including oncology, vaccines, infectious diseases, cardio-metabolic disorders, and immunology.

4. How is MSD preparing for the loss of market exclusivity for Keytruda? MSD is diversifying its portfolio through strategic acquisitions, partnerships, and investments in R&D to develop new innovative treatments across various therapeutic areas.

5. What is MSD's global market presence? MSD operates in over 140 countries, leveraging its global footprint to maximize the reach of its products and tap into emerging markets.

Sources cited: [1] https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/ [2] https://www.merck.com/news/merck-reports-strong-momentum-in-expanding-and-enabling-access-to-health-care-driving-sustainability-and-operating-responsibly-in-2023-2024-impact-report/ [3] https://blog.osum.com/merck-swot-analysis/ [4] https://en.wikipedia.org/wiki/Merck_&_Co. [5] https://pitchgrade.com/companies/merck-co [7] https://www.proclinical.com/blogs/2024-7/who-are-the-top-10-pharma-companies-in-the-world-2024 [10] https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/