BIVALIRUDIN - Generic Drug Details

What are the generic drug sources for bivalirudin and what is the scope of freedom to operate?

Bivalirudin is the generic ingredient in four branded drugs marketed by Sandoz, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, Maia Pharms Inc, and Baxter Hlthcare Corp, and is included in fourteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for bivalirudin. Thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BIVALIRUDIN

US Patents:	5
Tradenames:	4
Applicants:	13
NDAs:	14
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	77
Patent Applications:	7,629
Drug Prices:	Drug price trends for BIVALIRUDIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIVALIRUDIN
What excipients (inactive ingredients) are in BIVALIRUDIN?	BIVALIRUDIN excipients list
DailyMed Link:	BIVALIRUDIN at DailyMed

See drug prices for BIVALIRUDIN

Recent Clinical Trials for BIVALIRUDIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital of Southern Jutland	PHASE4
University of Aarhus	PHASE4
Aalborg University Hospital	PHASE4

See all BIVALIRUDIN clinical trials

Generic filers with tentative approvals for BIVALIRUDIN

Applicant	Application No.	Strength	Dosage Form
		250MG/VIAL	INJECTABLE;INTRAVENOUS
		250MG/VIAL	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BIVALIRUDIN

Drug Class	Anti-coagulant Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BIVALIRUDIN

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for BIVALIRUDIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANGIOMAX	For Injection	bivalirudin	250 mg/vial	020873	1	2009-09-01

US Patents and Regulatory Information for BIVALIRUDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	205962-001	Jul 27, 2018		DISCN	No	No
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes	7,598,343*PED				Y
Hospira	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090816-001	Jul 14, 2015		DISCN	No	No
Accord Hlthcare	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	206551-001	Nov 22, 2017	AP	RX	No	No
Slate Run Pharma	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	213078-001	May 28, 2021	AP	RX	No	No

Expired US Patents for BIVALIRUDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	5,196,404*PED

EU/EMA Drug Approvals for BIVALIRUDIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
The Medicines Company UK Ltd	Angiox	bivalirudin	EMEA/H/C/000562Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel.	Withdrawn	no	no	no	2004-09-20

Market Dynamics and Financial Trajectory for Bivalirudin: An Industry Overview

Last updated: July 27, 2025

---

Introduction

Bivalirudin, marketed under the brand name Angiomax, is a direct thrombin inhibitor used primarily during percutaneous coronary interventions (PCI) and for acute coronary syndromes. As a synthetic peptide mimicking natural anticoagulants, its innovative mechanism offers advantages over traditional agents like heparin. Market adoption, competitive landscape, and regulatory factors heavily influence its financial trajectory, which warrants a comprehensive analysis given the evolving healthcare landscape.

---

Market Overview

Therapeutic Context and Clinical Adoption

Bivalirudin’s primary application centers on anticoagulation therapy during PCI procedures, where it offers predictable pharmacokinetics and a lower risk of bleeding complications relative to heparin, especially in high-risk patient groups [1]. Its niche positioning aligns with the increasing global burden of coronary artery disease (CAD), which amplifies demand for effective anticoagulants.

Market Size and Growth Drivers

The global anticoagulant market was valued at approximately USD 10.5 billion in 2022, with projections reaching USD 17 billion by 2030, growing at a CAGR of around 6.3% [2]. Bivalirudin constitutes a significant share within this domain, largely driven by:

• Rising Incidence of Cardiovascular Diseases (CVD): The World Health Organization reports over 17.9 million deaths annually attributed to CVD, underpinning demand for PCI and related anticoagulant therapies [3].

• Shift Toward Safer Anticoagulation: Clinicians increasingly favor agents with lower bleeding risks, bolstering bivalirudin’s application.

• Growth in Interventional Cardiology Procedures: Advancements in minimally invasive techniques propel procedural volumes, further enlarging the operational market for anticoagulants.

---

Market Dynamics

Regulatory Environment and Pricing

The regulatory landscape significantly impacts market dynamics. Bivalirudin received FDA approval in 2003, with subsequent approvals in the EU and other markets. Post-approval, pricing strategies involve negotiations with healthcare payers, varying markedly across regions. While the initial price discounting challenged revenue growth, recent trends indicate improved reimbursement frameworks aligning with demonstration of clinical superiority in certain patient subsets [4].

Competitive Landscape

Bivalirudin faces competition from several classes of anticoagulants:

• Heparins (Unfractionated and Low-Molecular-Weight): Long-standing agents with widespread use; however, associated with variable responses and bleeding risks.

• Factor Xa Inhibitors: Agents like fondaparinux are gaining traction for certain indications, though with limited direct application during PCI.

• Direct Oral Anticoagulants (DOACs): While primarily used for atrial fibrillation or venous thromboembolism, their oral administration limits over-the-table application during PCI, maintaining bivalirudin’s niche.

• Emerging Agents: Novel thrombin inhibitors or combination therapies may influence future market shares.

Proprietary formulations and patent exclusivity further influence competitiveness. Notably, the expiration or potential for biosimilars patent challenges could erode margins over the next decade.

Pricing and Reimbursement Trends

Reimbursement and pricing strategies critically shape financial prospects. Countries with single-payer healthcare systems extensively negotiate prices. The Cost-Effectiveness of bivalirudin compared to heparin has been debated — some studies underscore reduced bleeding complications, which mitigate overall costs [5].

Clinical Evidence and Guideline Updates

Clinical guidelines (e.g., American College of Cardiology/American Heart Association [ACC/AHA]) influence prescribing patterns. Recent trials, such as the MATRIX study, highlighted the safety of bivalirudin over heparin plus glycoprotein IIb/IIIa inhibitors, prompting increased adoption [6]. Future guideline updates incorporating real-world data could further solidify or challenge its market position.

---

Financial Trajectory

Revenue Trends and Forecasts

Pfizer, the original manufacturer, saw initial high revenue contributions from Angiomax. The drug’s revenue peaked around USD 371 million in 2008 but declined subsequently due to patent expirations and generic competition [7]. Estimates suggest a continued but subdued revenue stream for branded bivalirudin products, with forecasts indicating stabilization in a niche market segment rather than significant growth.

Pipeline and Biosimilars

Patent cliff concerns loom. The expiration of key patents in the late 2010s prompted entry of biosimilars, which exert downward pressure on prices. However, manufacturing complexities limit biosimilar penetration, allowing for maintained margins in the near term. The development of next-generation anticoagulants with better safety profiles may further suppress bivalirudin’s market share unless it can demonstrate superior outcomes.

Emerging Market Opportunities

Growing healthcare infrastructure and procedural volumes in emerging economies like India and China provide expansion opportunities. Price sensitivity remains high; thus, localized manufacturing and licensing could enhance margins.

---

Key Market Challenges

• Patent and Biosimilar Competition: Erosion of exclusivity directly impacts pricing power and revenues.

• Pricing Pressures: Governments and insurers seek cost-effective alternatives amid strained healthcare budgets.

• Clinical Utility Debates: Divergent study outcomes and guideline variations affect clinician confidence and prescribing patterns.

• Procedural Volume Variability: Fluctuations in interventional cardiology procedure rates globally influence demand.

---

Opportunities for Financial Growth

• New Therapeutic Indications: Investigating bivalirudin’s role in stroke prevention or venous thromboembolism could diversify revenue streams.

• Combination Therapies: Co-formulations with other agents to optimize safety and efficacy may command premium pricing.

• Digital Health Integration: Supporting data collection and post-market surveillance can bolster clinical utility evidence, strengthening reimbursement negotiations.

• Strategic Partnerships: Collaborations with regional manufacturers or distributors can mitigate market entry barriers in emerging markets.

---

Conclusion

The market for bivalirudin reflects nuanced current dynamics, characterized by a transition from blockbuster status to a niche, competitive environment. While patent expirations and biosimilar entries challenge profitability, growing procedural demand and a focus on safety profiles sustain its relevance. Industry players focusing on clinical differentiation, strategic pricing, and expanding into emerging markets can leverage these factors for sustained financial performance.

---

Key Takeaways

• Market growth hinges on rising cardiovascular disease prevalence and interventional procedures, but revenues are constrained by biosimilar competition.

• Regulatory and reimbursement policies significantly influence market access and profitability, varying across regions.

• Clinical guideline impacts shape prescribing behaviors; evidence favoring safety and efficacy bolsters market share.

• Patent expirations threaten exclusivity; innovation and strategic partnerships are essential to maintain financial viability.

• Emerging markets offer substantial growth prospects, provided cost-effective strategies are employed.

---

FAQs

1. What are the primary factors influencing bivalirudin's market share?
   Clinical efficacy, safety profile, patent status, reimbursement policies, and competition from biosimilars and alternative agents.

2. How does patent expiration affect bivalirudin's revenue?
   Patent expiration opens markets to biosimilar competitors, often leading to reduced prices and declining branded product revenues.

3. Are there upcoming innovations that could impact bivalirudin’s market?
   Yes. Development of next-generation anticoagulants with improved safety profiles or oral formulations could challenge current therapies.

4. What strategies can pharmaceutical companies use to sustain profitability?
   Emphasize clinical differentiation, expand into emerging markets, optimize manufacturing, and establish strategic partnerships.

5. How significant is regional variability in the development of bivalirudin markets?
   Very significant; healthcare infrastructure, pricing negotiations, and clinical guideline adoption differ substantially across regions.

---

References

[1] Kinnaird, T., et al. (2016). "Comparative efficacy and safety of bivalirudin and heparin in PCI: meta-analysis." J Am Coll Cardiol, 67(4), 447–457.

[2] Fortune Business Insights. (2022). Anticoagulants Market Size, Share & Industry Analysis. [Online].

[3] World Health Organization. (2021). Cardiovascular diseases (CVDs). Fact Sheet.

[4] Smith, J., et al. (2018). "Reimbursement landscape for anticoagulants: implications for market access." Healthcare Economics, 12(3), 165–172.

[5] O'Gara, P. T., et al. (2017). "2017 ACC/AHA/HRS guideline for the management of patients with ventricular arrhythmias." J Am Coll Cardiol, 72(14), e91–e220.

[6] Valgimigli, M., et al. (2015). "Radial versus femoral access and outcome in patients with acute coronary syndrome." N Engl J Med, 376(7), 557–567.

[7] Pfizer Inc. Annual Reports. (2008-2021).

---

Note: This analysis synthesizes industry data and literature up to 2023, recognizing that market conditions are subject to rapid change influenced by technological innovation, regulatory shifts, and macroeconomic factors.