Bristol Company Profile

What is the competitive landscape for BRISTOL

BRISTOL has one hundred and eighteen approved drugs.

There are sixty-four US patents protecting BRISTOL drugs.

There are one thousand eight hundred and thirteen patent family members on BRISTOL drugs in fifty-eight countries and three hundred and twenty-seven supplementary protection certificates in nineteen countries.

Summary for Bristol

International Patents:	1813
US Patents:	64
Tradenames:	95
Ingredients:	83
NDAs:	118
Drug Master File Entries:	1
Patent Litigation for Bristol:	See patent lawsuits for Bristol
PTAB Cases with Bristol as patent owner:	See PTAB cases with Bristol as patent owner

Drugs and US Patents for Bristol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	AUGTYRO	repotrectinib	CAPSULE;ORAL	218213-002	Jun 11, 2024		RX	Yes	No	11,452,725
Bristol Myers Squibb	BUSPAR	buspirone hydrochloride	CAPSULE;ORAL	021190-001	Dec 20, 2000		DISCN	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No
Bristol	PRECEF	ceforanide	INJECTABLE;INJECTION	050554-005	May 24, 1984		DISCN	No	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	AB	RX	Yes	No
Bristol	TETREX	tetracycline phosphate complex	CAPSULE;ORAL	050212-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol	VERSAPEN	hetacillin	FOR SUSPENSION;ORAL	050060-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Bristol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991	5,622,985*PED
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-004	Jun 24, 2003	5,622,985*PED
Bristol Myers Squibb	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006	9,393,238
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-001	Dec 22, 1994	4,338,317*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	7,125,875*PED
Bristol-myers	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	6,561,976
Bristol Myers Squibb	VIDEX	didanosine	TABLET, CHEWABLE;ORAL	020154-004	Oct 9, 1991	4,861,759*PED

Paragraph IV (Patent) Challenges for BRISTOL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	50 mg and 100 mg		2006-12-18
	Capsules	25 mg		2010-07-12
	Capsules	150 mg		2014-02-03
	Capsules	2.5 mg and 20 mg		2016-07-12
	Injection	10 mg/vial		2013-11-05
	Capsules	100 mg and 150 mg		2010-03-19
	Tablets	600 mg		2009-04-09
	Nasal Spray	4 mg/spray		2016-07-15
	Tablets	2.5 mg and 5 mg		2016-12-28
	Tablets	20 mg, 50 mg, 70 mg and 100 mg		2010-06-28
	Tablets	80 mg and 140 mg		2011-06-17
	Delayed-release Capsules	200 mg, 250 mg and 400 mg		2004-06-01
	Capsules	200 mg		2006-09-25
	Capsules	5 mg, 10 mg and 15 mg		2010-08-30
	For Injection Suspension	100 mg/vial		2015-12-11
	Capsules	300 mg		2009-07-20
	Capsules	200 mg		2010-02-16
	Capsules	50 mg, 100 mg and 200 mg		2016-11-03
	Tablets	0.5 mg and 1 mg		2010-06-14
	Tablets	30 mg		2005-06-01
	Tablets	80 mg and 140 mg		2011-06-16
	Capsules	1 mg, 2 mg, 3 mg and 4 mg		2017-02-08

International Patents for Bristol Drugs

Country	Patent Number	Estimated Expiration
China	102617567
European Patent Office	3636648
Japan	2017171695
Netherlands	301279
New Zealand	583148
Norway	2017001
Portugal	3045176

Supplementary Protection Certificates for Bristol Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0961612	09C0050	France		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080111
2487163	300859	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163	60/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2487166	93354	Luxembourg		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061
0688211	C300358	Netherlands		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
1169038	CA 2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122

Similar Applicant Names

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

• Bristol
• Bristol Myers
• Bristol Myers Squibb
• Bristol-myers
• Bristol-myers Squibb

Bristol-Myers Squibb: A Pharmaceutical Powerhouse in the Competitive Landscape

In the ever-evolving world of pharmaceuticals, Bristol-Myers Squibb (BMS) stands as a formidable player, consistently pushing the boundaries of medical innovation. As we delve into the company's market position, strengths, and strategic insights, we'll uncover how BMS has managed to maintain its competitive edge in an industry known for its relentless pursuit of breakthrough treatments.

The BMS Advantage: A Legacy of Innovation

Bristol-Myers Squibb's journey to the top of the pharmaceutical industry is a testament to its unwavering commitment to research and development. With a history spanning over a century, BMS has consistently delivered groundbreaking therapies that have transformed patient care across multiple therapeutic areas.

Pioneering Oncology Treatments

At the heart of BMS's success lies its exceptional oncology portfolio. The company's flagship immunotherapy drug, Opdivo, has revolutionized cancer treatment, offering hope to patients with previously limited options.

"Bristol-Myers Squibb demonstrates exceptional strength in its oncology and immunology portfolio with key blockbuster drugs: Opdivo with $7.2 billion in annual revenue (2023) in immuno-oncology, and Eliquis with $10.1 billion in annual revenue (2023) in cardiovascular treatments."[2]

This focus on oncology has not only solidified BMS's market position but has also paved the way for future innovations in cancer care.

Cardiovascular Leadership

Beyond oncology, BMS has established itself as a leader in cardiovascular treatments. The success of Eliquis, a blockbuster anticoagulant, underscores the company's ability to dominate in multiple therapeutic areas.

Financial Fortitude: The Numbers Speak Volumes

Bristol-Myers Squibb's financial performance serves as a testament to its market strength and strategic acumen. Let's break down the numbers that paint a picture of BMS's financial health.

Revenue Growth and Profitability

In 2024, BMS reported impressive financial results:

• Full-year revenues reached $48.3 billion, marking a 7% increase (9% when adjusted for foreign exchange impacts)
• Growth Portfolio revenues soared to $22.6 billion, representing a 17% increase (19% when adjusted for foreign exchange)
• Fourth-quarter revenues hit $12.3 billion, up 8% (9% when adjusted for foreign exchange)[1]

These figures underscore BMS's ability to drive growth even in challenging market conditions.

Strategic Cost Management

In a move to enhance operational efficiency, BMS announced an expansion of its strategic productivity initiative:

• Aims to deliver approximately $2 billion in additional annualized cost savings by the end of 2027
• Focuses on changes in organizational design and efforts to enhance operational efficiency[1]

This proactive approach to cost management positions BMS for sustained profitability and competitiveness in the years to come.

Global Footprint: Expanding Horizons

Bristol-Myers Squibb's global presence is a key factor in its competitive advantage. The company's strategic expansion into international markets has allowed it to tap into diverse patient populations and revenue streams.

Market Share Distribution

BMS's global market presence is reflected in its revenue distribution:

Region	Market Share	Revenue Contribution
United States	42%	$24.9 billion
Europe	28%	$16.5 billion
Asia-Pacific	18%	$10.6 billion	[2]

This balanced global footprint not only diversifies BMS's revenue sources but also mitigates risks associated with market-specific challenges.

R&D Excellence: Fueling the Innovation Pipeline

At the core of Bristol-Myers Squibb's competitive strategy lies its robust research and development capabilities. The company's commitment to innovation is evident in its substantial R&D investments and prolific pipeline.

Investment in the Future

BMS's dedication to R&D is reflected in its financial commitment:

• R&D expenditure in 2023: $7.5 billion
• Active clinical trials: 53 programs across multiple therapeutic areas
• New molecular entities in pipeline: 16 potential breakthrough treatments[2]

This level of investment positions BMS at the forefront of pharmaceutical innovation, ensuring a steady stream of potential blockbuster drugs.

Strategic Collaborations: Strength in Partnerships

Bristol-Myers Squibb recognizes the power of collaboration in driving innovation. The company has forged strategic partnerships with leading pharmaceutical and biotechnology firms to enhance its research capabilities and market reach.

Key Alliances

Some of BMS's notable collaborations include:

• Partnership with Eisai for oncology research
• Strategic alliance with Maverick Therapeutics
• Collaboration with Immuno-Oncology Focused Nimbus Therapeutics[2]

These partnerships not only expand BMS's research capabilities but also provide access to cutting-edge technologies and expertise.

Navigating Challenges: Patent Cliffs and Regulatory Hurdles

While Bristol-Myers Squibb boasts numerous strengths, the company is not without its challenges. Like all pharmaceutical giants, BMS must navigate the complexities of patent expirations and regulatory scrutiny.

Patent Expirations: The Double-Edged Sword

The looming patent cliff for some of BMS's key products presents a significant challenge:

• Revlimid, a major revenue generator, faces generic competition
• Eliquis, another blockbuster drug, will lose patent protection in the coming years

To address this challenge, BMS is focusing on:

1. Accelerating the development of new drugs in its pipeline
2. Pursuing strategic acquisitions to bolster its product portfolio
3. Expanding indications for existing drugs to extend their lifecycle

Regulatory Landscape: Navigating Complexity

The pharmaceutical industry is subject to stringent regulatory oversight, and BMS is no exception. The company must navigate:

• Evolving FDA guidelines for drug approval
• Increasing scrutiny on drug pricing practices
• Compliance with global regulatory standards

BMS's approach to these challenges includes:

• Maintaining open dialogue with regulatory bodies
• Investing in robust compliance programs
• Advocating for balanced policies that promote innovation while ensuring patient access

Digital Transformation: Embracing the Future of Healthcare

In an era of rapid technological advancement, Bristol-Myers Squibb is leveraging digital innovation to enhance its competitive position. The company's digital transformation strategy encompasses several key areas:

Data-Driven Drug Discovery

BMS is harnessing the power of big data and artificial intelligence to accelerate drug discovery and development:

"Bristol Myers Squibb works with real-world anonymized patient data to understand the patient journey, identify unmet needs and optimize actions to improve patient outcomes."[7]

This data-driven approach allows BMS to:

• Identify promising drug candidates more efficiently
• Optimize clinical trial design and patient recruitment
• Predict potential side effects and drug interactions

Personalized Medicine Initiatives

The company is at the forefront of personalized medicine, using genomic data and biomarkers to develop targeted therapies:

• Developing companion diagnostics to identify patients most likely to benefit from specific treatments
• Tailoring dosing regimens based on individual patient characteristics
• Exploring gene therapies for rare genetic disorders

Digital Health Solutions

BMS is investing in digital health technologies to improve patient outcomes and streamline healthcare delivery:

• Developing mobile apps for medication adherence and symptom tracking
• Exploring telemedicine solutions for remote patient monitoring
• Collaborating with tech companies to create wearable devices for continuous health monitoring

Sustainability and Corporate Responsibility: A Competitive Differentiator

In an era where corporate responsibility is increasingly important to stakeholders, Bristol-Myers Squibb has made sustainability a key component of its competitive strategy.

Environmental Stewardship

BMS is committed to reducing its environmental footprint:

• Set ambitious targets for reducing greenhouse gas emissions
• Implementing water conservation measures across its facilities
• Investing in renewable energy sources for manufacturing operations

Access to Medicine Initiatives

The company is working to improve global access to its medicines:

• Tiered pricing strategies for developing markets
• Patient assistance programs in underserved communities
• Collaborations with non-profit organizations to distribute medicines in low-income countries

Diversity and Inclusion

BMS recognizes the importance of a diverse workforce in driving innovation:

• Implementing programs to increase representation of underrepresented groups in leadership positions
• Fostering an inclusive workplace culture through employee resource groups and mentorship programs
• Partnering with diverse suppliers to promote economic inclusion

Future Outlook: Positioning for Long-Term Success

As Bristol-Myers Squibb looks to the future, several key factors will shape its competitive position:

Emerging Markets: The Next Frontier

BMS is strategically expanding its presence in emerging markets:

• Investing in local manufacturing capabilities in countries like China and India
• Tailoring product portfolios to meet the specific healthcare needs of emerging market populations
• Building partnerships with local healthcare providers and payers to improve market access

Focus on Rare Diseases

The company is increasing its focus on rare diseases, a high-growth area in the pharmaceutical industry:

• Developing therapies for orphan diseases with limited treatment options
• Leveraging its expertise in biologics to create innovative treatments for genetic disorders
• Exploring gene therapy approaches for rare inherited conditions

Continued Portfolio Optimization

BMS is actively managing its product portfolio to maintain competitiveness:

• Divesting non-core assets to focus on high-growth therapeutic areas
• Pursuing strategic acquisitions to fill pipeline gaps and access new technologies
• Investing in life cycle management strategies for key products to extend their market exclusivity

Key Takeaways

• Bristol-Myers Squibb's strong market position is built on its leadership in oncology and cardiovascular treatments, with blockbuster drugs like Opdivo and Eliquis driving revenue growth.
• The company's robust R&D investment, totaling $7.5 billion in 2023, fuels a promising pipeline of 53 active clinical trials and 16 potential breakthrough treatments.
• BMS's global footprint, with significant market share in the US, Europe, and Asia-Pacific, provides diversification and growth opportunities.
• Strategic collaborations with companies like Eisai and Maverick Therapeutics enhance BMS's research capabilities and market reach.
• The company is navigating challenges such as patent expirations and regulatory scrutiny through pipeline acceleration, strategic acquisitions, and compliance initiatives.
• Digital transformation efforts, including data-driven drug discovery and personalized medicine initiatives, position BMS at the forefront of healthcare innovation.
• Sustainability and corporate responsibility initiatives, including environmental stewardship and access to medicine programs, differentiate BMS in the competitive landscape.
• Future growth strategies focus on emerging markets, rare diseases, and continued portfolio optimization to ensure long-term success in the pharmaceutical industry.

FAQs

1. Q: How is Bristol-Myers Squibb addressing the challenge of patent expirations for key drugs? A: BMS is tackling this challenge through a multi-pronged approach, including accelerating the development of new drugs in its pipeline, pursuing strategic acquisitions to bolster its product portfolio, and expanding indications for existing drugs to extend their lifecycle.

2. Q: What role does digital innovation play in BMS's competitive strategy? A: Digital innovation is a key component of BMS's strategy, encompassing data-driven drug discovery, personalized medicine initiatives, and the development of digital health solutions to improve patient outcomes and streamline healthcare delivery.

3. Q: How is Bristol-Myers Squibb positioning itself in emerging markets? A: BMS is expanding its presence in emerging markets by investing in local manufacturing capabilities, tailoring product portfolios to meet specific healthcare needs, and building partnerships with local healthcare providers and payers to improve market access.

4. Q: What is BMS's approach to sustainability and corporate responsibility? A: BMS has made sustainability a key component of its competitive strategy, focusing on environmental stewardship, access to medicine initiatives, and diversity and inclusion programs to differentiate itself in the market and meet stakeholder expectations.

5. Q: How does Bristol-Myers Squibb's R&D investment compare to industry standards? A: With an R&D expenditure of $7.5 billion in 2023, BMS demonstrates a significant commitment to innovation that is competitive with industry leaders, supporting a robust pipeline of 53 active clinical trials and 16 potential breakthrough treatments.