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Last Updated: December 12, 2025

Bristol-myers Company Profile


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Drugs and US Patents for Bristol-myers

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes 9,511,046*PED ⤷  Get Started Free Y ⤷  Get Started Free
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-001 Sep 26, 2024 RX Yes No 10,369,144 ⤷  Get Started Free Y ⤷  Get Started Free
Bristol-myers COBENFY trospium chloride; xanomeline tartrate CAPSULE;ORAL 216158-003 Sep 26, 2024 RX Yes Yes 11,890,378 ⤷  Get Started Free Y ⤷  Get Started Free
Bristol-myers ABRAXANE paclitaxel POWDER;INTRAVENOUS 021660-001 Jan 7, 2005 AB RX Yes Yes 8,268,348*PED ⤷  Get Started Free Y ⤷  Get Started Free
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No 8,900,566 ⤷  Get Started Free ⤷  Get Started Free
Bristol-myers INREBIC fedratinib hydrochloride CAPSULE;ORAL 212327-001 Aug 16, 2019 RX Yes Yes 10,391,094 ⤷  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 Bristol-myers

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 8,589,188 ⤷  Get Started Free
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 8,204,763 ⤷  Get Started Free
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 6,315,720 ⤷  Get Started Free
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-003 Jan 17, 2003 8,143,283 ⤷  Get Started Free
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-001 Jul 16, 1998 6,755,784 ⤷  Get Started Free
Bristol-myers THALOMID thalidomide CAPSULE;ORAL 020785-002 Jan 17, 2003 5,629,327 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for BRISTOL-MYERS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Capsules 50 mg and 100 mg ➤ Subscribe 2006-12-18
➤ Subscribe Capsules 150 mg ➤ Subscribe 2014-02-03
➤ Subscribe Injection 10 mg/vial ➤ Subscribe 2013-11-05
➤ Subscribe Capsules 200 mg ➤ Subscribe 2006-09-25
➤ Subscribe For Injection Suspension 100 mg/vial ➤ Subscribe 2015-12-11

Supplementary Protection Certificates for Bristol-myers Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1951684 132021000000053 Italy ⤷  Get Started Free PRODUCT NAME: FEDRATINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, O UN SUO IDRATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE FEDRATINIB DICLORIDRATO MONOIDRATO(INREBIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1514, 20210209
1853250 C300673 Netherlands ⤷  Get Started Free PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250 300673 Netherlands ⤷  Get Started Free PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1951684 CA 2021 00011 Denmark ⤷  Get Started Free PRODUCT NAME: FEDRATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET FARMACEUTISK ACCEPTABELT HYDRAT DERAF, ISAER FEDRATINIB-DIHYDROCHLORIDMONOHYDRAT; REG. NO/DATE: EU/1/20/1514 20210209
1951684 C20210010 00394 Estonia ⤷  Get Started Free PRODUCT NAME: FEDRATINIIB;REG NO/DATE: EU/1/20/1514; 09.02.2021
2049522 SPC/GB15/003 United Kingdom ⤷  Get Started Free PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTERED: UK EU/1/14/939/001-004 20140826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: BRISTOL-MYER'S – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025

Introduction

Bristol-Myers Squibb (BMS) stands as a prominent multinational biopharmaceutical powerhouse, deeply embedded within the competitive landscape of innovative medicines. With an expansive portfolio spanning oncology, immunology, cardiovascular, and neuroscience, BMS's strategic positioning influences its resilience and growth trajectory amid evolving industry dynamics. This analysis dissects Bristol-Myers's market stance, core competencies, and future-oriented strategic pursuits to inform stakeholders seeking a comprehensive understanding of its competitive edge.

Market Position and Industry Footprint

Bristol-Myers Squibb has secured a formidable position in the global pharmaceutical arena. As of 2023, it ranks among the top-tier biotech companies by revenue and R&D investment. The company's strategic focus on delivering transformative therapies in oncology (notably immuno-oncology agents like Opdivo) and immunology (e.g., Orencia) has driven consistent revenue growth.

Revenue Composition and Key Therapeutic Areas

  • Oncology: The cornerstone of BMS's portfolio, contributing approximately 55-60% of total revenue [1]. Its flagship products, Opdivo (nivolumab) and Yervoy (ipilimumab), dominate the immune checkpoint inhibitor market, a rapidly expanding segment.

  • Immunoscience: Including drugs like Orencia (abatacept), which address autoimmune disorders such as rheumatoid arthritis. Although smaller than oncology, this segment remains crucial for diversification.

  • Late-Stage Pipeline and Emerging Areas: BMS is capitalizing on the rise of cell therapy and personalized medicine, expanding into bispecific antibodies and CAR-T therapies, which position it favorably against competitors like Merck (Keytruda) and Roche.

Market Share and Competitive Position

In 2022, BMS held approximately 18% of the global immuno-oncology drug market [2], with its flagship agents competing directly with Merck's Keytruda and Roche's Tecentriq. Its strategic acquisitions, notably Celgene in 2019, expanded its pipeline and market share, bolstering its presence in hematologic malignancies and immunology.

Strengths and Competitive Advantages

Innovative R&D and Robust Pipeline

BMS invests approximately 20% of its revenue into R&D, fostering a pipeline rich with promising candidates spanning multiple therapeutic areas. Its focus on novel immunotherapies and personalized medicine differentiates it from traditional pharmaceutical competitors, enabling the development of first-in-class drugs that secure high market exclusivity periods.

Strategic Acquisitions and Collaborations

The acquisition of Celgene elevated BMS’s oncology and hematology portfolios, notably adding Revlimid and Pomalyst, and catalyzed a pipeline centered around cell therapies and immunomodulators. Strategic alliances with biotech firms and academic institutions further augment innovation capacity.

Global Commercial Footprint

BMS benefits from a diversified geographic footprint, with established operations in North America, Europe, and Asia-Pacific. Its wide-reaching sales network enhances product penetration and market resilience, particularly critical amid regional regulatory challenges.

Regulatory Success and Market Exclusivity

BMS boasts a track record of navigating complex regulatory pathways efficiently, securing approvals for breakthrough therapies. Its ability to secure market exclusivity through patents and expanded indications prolongs revenues and deters competitors.

Challenges and Strategic Risks

Intense Competition and Patent Expirations

The immuno-oncology landscape is highly competitive, with Merck’s Keytruda maintaining a lead in market share. Expiring patents, notably on Revlimid (2026), pose risks to revenue streams, necessitating pipeline acceleration and diversification.

Pricing Pressures and Healthcare Reforms

Growing global emphasis on drug affordability, especially in the U.S. and Europe, pressures BMS to adopt innovative pricing and value-based care models. Navigating regulatory landscapes that favor cost-effective therapies remains critical.

Pipeline Uncertainties

While BMS’s R&D investments are substantial, the inherent risks of clinical trial failures pose a threat to pipeline health. The transition from promising candidates in early phases to commercially successful drugs is not guaranteed.

Strategic Insights and Future Outlook

Emphasis on Next-Generation Immunotherapies

BMS’s pipeline includes bispecific antibodies, personalized cell therapies, and novel checkpoint inhibitors aimed at overcoming resistance mechanisms and broadening therapeutic applicability. The integration of artificial intelligence (AI) in drug discovery further enhances efficiency.

Expansion into Cell and Gene Therapy

Capitalizing on advances in precision medicine, BMS’s initiatives in CAR-T therapies and gene editing hold promise for disrupting traditional treatment paradigms. Its joint ventures and acquisitions in this space will be vital to its long-term growth.

Digital Transformation and Data Integration

BMS is leveraging digital technologies to improve clinical trial efficiency, patient monitoring, and post-market surveillance. Such data-driven approaches bolster its competitive positioning by reducing time-to-market and enhancing patient outcomes.

Focus on Emerging Markets

Expanding access in emerging economies via partnerships, localized manufacturing, and pricing strategies will broaden BMS’s reach. These markets offer significant growth potential amidst rising healthcare expenditures.

Key Takeaways

  • Bristol-Myers Squibb stands as a leader in immuno-oncology, with a diversified portfolio and strategic acquisitions enhancing its market position.
  • Its long-standing R&D commitment and pipeline innovation underpin sustained competitive advantage.
  • Challenges include patent expirations and competitive pressures, which BMS mitigates through pipeline expansion and strategic collaborations.
  • Future success hinges on advancing next-generation immunotherapies, embracing cell and gene therapies, and leveraging digital innovations.
  • To maintain its industry leadership, BMS must navigate regulatory landscapes smartly while expanding its footprint in emerging markets.

FAQs

1. How does Bristol-Myers Squibb’s market position compare to peers like Merck and Roche?
BMS is a leading immuno-oncology player, holding approximately 18% of the global market share in immuno-oncology as of 2022 [2]. While Merck's Keytruda leads in market share, BMS's strong product portfolio and recent pipeline innovations position it as a close competitor. Roche’s focus on complementary oncology and diagnostics diversifies its market presence, though BMS's emphasis on immunotherapy affords a competitive edge.

2. What are the primary growth drivers for Bristol-Myers Squibb?
Key drivers include its flagship immuno-oncology drugs (Opdivo, Yervoy), its expanding cell therapy pipeline, strategic acquisitions such as Celgene, and increased penetration into emerging markets. Investment in next-generation immunotherapies and personalized medicine also propels growth.

3. What risks threaten Bristol-Myers Squibb’s future prospects?
Patent cliffs, intense competition, regulatory challenges, pricing pressures, and clinical trial failures are significant risks. The transition from older blockbuster drugs (e.g., Revlimid) to newer therapies requires careful strategic management.

4. How is Bristol-Myers Squibb leveraging digital health and AI?
BMS employs AI to accelerate drug discovery, optimize clinical trials, and enhance post-market surveillance. Digital health initiatives improve patient engagement and data collection, streamlining R&D and improving outcomes.

5. What strategic initiatives will define Bristol-Myers Squibb’s next phase?
Focusing on next-generation immunotherapies, expanding cell and gene therapies, strengthening collaborations, and penetrating emerging markets are central. Embracing digital transformation and personalized treatment approaches will underpin its future competitiveness.

References

[1] Bureau of Economic Analysis, 2022. Company Financials.
[2] IQVIA, 2022. Global Oncology Market Report.

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