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. Fifteen 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:	15
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	72
Patent Applications:	5,734
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
Sydney Local Health District	Phase 2
Veralox Therapeutics	Phase 2
University Magna Graecia	N/A

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
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	11,918,622
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	11,903,993
Apotex	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	204876-001	Jul 6, 2017		DISCN	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/000562 Angiox 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

BIVALIRUDIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bivalirudin

Introduction to Bivalirudin

Bivalirudin is a direct thrombin inhibitor used primarily in the treatment of patients undergoing percutaneous coronary intervention (PCI) and other cardiovascular procedures. It has gained significant attention due to its efficacy in reducing ischemic complications and bleeding risks compared to traditional anticoagulant therapies.

Market Size and Growth Projections

The global market for bivalirudin is experiencing robust growth. As of 2023, the market was estimated to be worth US$ 596 million. It is forecasted to reach a readjusted size of US$ 887.2 million by 2030, with a compound annual growth rate (CAGR) of 6.5% during the forecast period of 2024-2030[1].

Key Drivers of Market Growth

Increasing Incidence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases (CVDs) worldwide is a significant driver of the bivalirudin market. CVDs are the leading cause of death globally, accounting for 32% of all deaths in 2019. The high prevalence of coronary artery disease, heart failure, and other CVDs in regions like North America and Europe is expected to drive the demand for bivalirudin in PCI procedures[3].

Cost-Effectiveness and Reduced Bleeding Risks

Studies have shown that bivalirudin, when used with provisional glycoprotein IIb/IIIa inhibition, reduces major and minor bleeding rates compared to heparin plus routine glycoprotein IIb/IIIa inhibition. This reduction in bleeding complications leads to significant cost savings, estimated at $375 to $400 per patient, which is a compelling factor for its adoption[2][5].

Expanding Applications

Bivalirudin is not only used in PCI procedures but also in other cardiovascular interventions such as percutaneous transluminal coronary angioplasty (PTCA). The expanding range of applications is further boosting the market growth[3].

Regional Market Analysis

North America

North America is expected to dominate the bivalirudin market, driven by the high prevalence of coronary artery disease and the frequent performance of PCI procedures in the region. Approximately 960,000 PCI procedures are performed annually in the United States, contributing significantly to the market size[3].

Europe, Asia Pacific, and Other Regions

Europe and the Asia Pacific region are also significant markets for bivalirudin, with growing demand driven by increasing cases of cardiovascular diseases. The Middle East and Africa, along with Latin America, are emerging markets with potential for future growth[4].

Competitive Landscape

The bivalirudin market is characterized by a competitive landscape with several key players. These include The Medicines Company, Sandoz, Fresenius Kabi, Pfizer, Mylan, Dr. Reddy's Laboratories, Apotex, Accord Healthcare, and Aurobindo Pharma. These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives[1][4].

Segmentation by Type and Application

The market is segmented by type, with the injection segment accounting for a noticeable share and expected to experience significant growth. By application, PCI procedures dominate the market, followed by PTCA and other cardiovascular interventions[3][4].

Financial Benefits and Cost Savings

The use of bivalirudin results in significant cost savings due to reduced bleeding complications and shorter hospital stays. A study found that bivalirudin with provisional glycoprotein IIb/IIIa inhibition reduced in-hospital and 30-day costs by $405 and $374 per patient, respectively, compared to heparin plus routine glycoprotein IIb/IIIa inhibition[2].

Long-Term Efficacy and Safety

Long-term follow-up studies have demonstrated that bivalirudin, when used with provisional glycoprotein IIb/IIIa inhibition, has comparable long-term clinical outcomes to heparin plus planned glycoprotein IIb/IIIa inhibition. This includes similar rates of death, myocardial infarction, and repeat revascularization, with the added benefit of reduced bleeding risks[5].

Market Trends and Opportunities

Technological Advancements

Advancements in medical technology and the development of new antithrombotic strategies are expected to further enhance the market for bivalirudin. Improved manufacturing processes and the integration of bivalirudin into various treatment protocols will continue to drive market growth[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of bivalirudin. Favorable regulatory approvals and guidelines supporting the use of bivalirudin in cardiovascular procedures will continue to support market expansion[4].

Challenges and Restraints

Competition from Alternative Therapies

The market for bivalirudin faces competition from other anticoagulant therapies. The availability of alternative treatments and the ongoing development of new antithrombotic agents could pose challenges to the growth of the bivalirudin market[4].

Cost and Accessibility

Despite its cost-effectiveness in the long term, the initial cost of bivalirudin can be a barrier to adoption in some regions. Ensuring accessibility and affordability, especially in emerging markets, is crucial for sustained market growth[2].

Key Takeaways

• The global bivalirudin market is projected to reach US$ 887.2 million by 2030, growing at a CAGR of 6.5% from 2024 to 2030.
• The market is driven by the increasing incidence of cardiovascular diseases and the cost-effectiveness of bivalirudin in reducing bleeding complications.
• North America is expected to dominate the market, with significant contributions from Europe and the Asia Pacific region.
• Key players are focusing on expanding their product portfolios and strengthening their market presence.
• Long-term efficacy and safety studies support the use of bivalirudin as a preferred antithrombotic strategy.

FAQs

1. What is the forecasted market size of bivalirudin by 2030?

The global market for bivalirudin is forecasted to reach US$ 887.2 million by 2030[1].

2. What is the primary application of bivalirudin?

Bivalirudin is primarily used in percutaneous coronary intervention (PCI) procedures and other cardiovascular interventions such as PTCA[3].

3. Which region is expected to dominate the bivalirudin market?

North America is expected to dominate the bivalirudin market due to the high prevalence of coronary artery disease and frequent PCI procedures in the region[3].

4. How does bivalirudin compare to heparin plus glycoprotein IIb/IIIa inhibition in terms of cost?

Bivalirudin with provisional glycoprotein IIb/IIIa inhibition results in cost savings of $375 to $400 per patient compared to heparin plus routine glycoprotein IIb/IIIa inhibition[2].

5. What are the long-term clinical outcomes of using bivalirudin?

Long-term follow-up studies have shown that bivalirudin has comparable clinical outcomes to heparin plus planned glycoprotein IIb/IIIa inhibition, with reduced bleeding risks[5].

Cited Sources:

1. Valuates Reports: Bivalirudin Drug - Market Size.
2. PubMed: Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIa inhibition.
3. Research Nester: Bivalirudin and Desmopressin Market Size & Share.
4. Cognitive Market Research: Global Bivalirudin Drug Market Report 2024 Edition.
5. JAMA Network: Long-term Efficacy of Bivalirudin and Provisional Glycoprotein IIb/IIIa Inhibition.