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 six 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. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BIVALIRUDIN

US Patents:	6
Tradenames:	4
Applicants:	13
NDAs:	14
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	78
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
The Fifth Hospital of Wuhan	NA
Wuhan No.3 Hospital	NA
Xiantao First People's Hospital	NA

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	11,992,514		Y
Hospira	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090811-001	Jul 14, 2015		DISCN	No	No
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes	7,582,727*PED				Y
Slate Run Pharma	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	213078-001	May 28, 2021	AP	RX	No	No
Hospira	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090816-001	Jul 14, 2015		DISCN	No	No
Meitheal	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	091602-001	Jul 16, 2018	AP	RX	No	No
Apotex	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	204876-001	Jul 6, 2017		DISCN	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

Bivalirudin: Market Landscape and Financial Outlook

Last updated: February 19, 2026

This report analyzes the current market dynamics and projected financial trajectory for bivalirudin, a direct thrombin inhibitor used primarily for anticoagulation in patients undergoing percutaneous coronary intervention (PCI). The analysis focuses on key market drivers, competitive landscape, patent expirations, and future revenue potential.

What is Bivalirudin's Primary Therapeutic Use?

Bivalirudin is indicated for anticoagulation in patients with or at risk of heparin-induced thrombocytopenia (HIT) undergoing PCI. It is a synthetic peptide analogue of the enzyme hirudin, which directly inhibits thrombin, a key enzyme in the coagulation cascade. This mechanism of action differentiates it from indirect thrombin inhibitors like heparin.

The drug's efficacy in reducing thrombotic events during PCI while also demonstrating a lower bleeding risk compared to some other anticoagulants has established its role in interventional cardiology. Its use is particularly prevalent in patients with a history or high risk of HIT, a serious complication of heparin therapy that involves immune-mediated platelet activation and aggregation, leading to potentially life-threatening thrombotic events.

What is the Current Market Size and Growth for Bivalirudin?

The global bivalirudin market size was estimated at approximately $850 million in 2023. Projections indicate a compound annual growth rate (CAGR) of 3.5% to 4.5% over the next five years, reaching an estimated $1.05 billion by 2028. This growth is driven by the increasing prevalence of cardiovascular diseases, a rising number of PCI procedures globally, and the drug's established safety and efficacy profile.

Metric	2023 Value	Projected 2028 Value	CAGR (2024-2028)
Market Size (USD)	$850M	$1.05B	3.5% - 4.5%

The demand for bivalirudin is closely tied to the volume of PCI procedures performed. The World Health Organization (WHO) reports a steady increase in cardiovascular disease incidence, necessitating interventions like angioplasty and stenting, which in turn drives the use of anticoagulants like bivalirudin.

Who are the Key Players in the Bivalirudin Market?

The bivalirudin market is characterized by a combination of originator and generic manufacturers. The primary originator product is Angiomax (The Medicines Company, now Novalung), which held a significant market share upon its launch.

Major Market Participants:

• The Medicines Company (Novalung): Originator of Angiomax, a key player in the branded segment.
• Generic Manufacturers: A growing number of companies have introduced generic versions of bivalirudin following patent expiries. Prominent generic players include:
  • Fresenius Kabi
  • Hikma Pharmaceuticals
  • Teva Pharmaceutical Industries
  • Viatris (formerly Mylan and Pfizer's Upjohn)
  • Sandoz (Novartis' generic division)

The entry of generics has led to price erosion and increased market accessibility, particularly in developed markets. Competition primarily centers on pricing, supply chain reliability, and market penetration strategies.

What is the Patent Landscape for Bivalirudin?

The patent landscape for bivalirudin is a critical factor influencing market dynamics. The primary patents protecting Angiomax have expired in major markets, paving the way for generic competition.

Key Patent Expirations:

• United States: The principal compound patent for bivalirudin expired in 2014. Subsequent formulation and method-of-use patents have also expired or are nearing expiration, with limited remaining exclusivity.
• Europe: Similar to the US, the core patents have expired, allowing for generic market entry.
• Other Markets: Patent expiries have occurred or are occurring across other key pharmaceutical markets.

While core patents have expired, some companies may hold secondary patents related to specific formulations, manufacturing processes, or new therapeutic indications. However, these are generally less impactful on the broad market availability of generic bivalirudin.

What are the Key Drivers of Bivalirudin Market Growth?

Several factors are contributing to the sustained growth of the bivalirudin market:

1. Increasing Prevalence of Cardiovascular Diseases: The rising global incidence of coronary artery disease, myocardial infarction, and stroke directly correlates with the demand for PCI procedures, a primary application for bivalirudin.
2. Growing Number of Percutaneous Coronary Interventions (PCI): Advances in interventional cardiology techniques and devices have led to a substantial increase in the number of PCI procedures performed worldwide. Bivalirudin is a standard anticoagulant for many of these procedures.
3. Established Efficacy and Safety Profile: Bivalirudin has a well-documented record of efficacy in preventing thrombotic events during PCI and a favorable safety profile regarding bleeding, especially in specific patient populations.
4. Heparin-Induced Thrombocytopenia (HIT) Risk: The ongoing risk of HIT associated with unfractionated and low-molecular-weight heparins makes bivalirudin a preferred alternative for patients with or at risk of developing HIT.
5. Generic Market Penetration: The availability of cost-effective generic versions of bivalirudin has broadened its accessibility, particularly in cost-sensitive healthcare systems, driving volume growth.

What are the Challenges Facing the Bivalirudin Market?

Despite positive growth indicators, the bivalirudin market faces several challenges:

1. Price Erosion Due to Generic Competition: The entry of multiple generic manufacturers has led to significant price reductions, impacting the revenue streams of both originator and generic companies.
2. Competition from Alternative Anticoagulants: While bivalirudin holds a strong position in PCI, it faces competition from other anticoagulant classes for different therapeutic indications. Furthermore, within the PCI space, newer anticoagulants or alternative strategies could emerge.
3. Reimbursement Policies: Evolving reimbursement policies and formulary restrictions in different healthcare systems can influence prescribing patterns and market access for bivalirudin.
4. Development of Novel Therapies: Continuous innovation in cardiovascular treatments could lead to the development of new anticoagulants or procedural techniques that reduce the reliance on existing drugs like bivalirudin.
5. Supply Chain Vulnerabilities: Like many pharmaceuticals, the bivalirudin supply chain can be susceptible to disruptions from raw material shortages, manufacturing issues, or geopolitical events.

What is the Competitive Landscape in the Bivalirudin Market?

The competitive landscape for bivalirudin is segmented into branded and generic products.

Branded Segment: The Medicines Company (Novalung) with Angiomax remains a significant player, particularly in markets where brand loyalty or specific contracts persist. However, its market share is steadily being eroded by generic alternatives.

Generic Segment: This segment is highly competitive, with numerous manufacturers vying for market share. Key competitive factors include:

• Pricing: Generic manufacturers often compete aggressively on price to gain market share.
• Manufacturing Capacity and Reliability: Consistent supply and robust manufacturing capabilities are crucial to secure contracts and meet demand.
• Geographic Reach: Companies with extensive distribution networks can access a wider patient population.
• Regulatory Approvals: Obtaining and maintaining regulatory approvals in diverse global markets is essential for expansion.

The presence of multiple generic suppliers intensifies price competition and necessitates efficient operational management for profitability.

What is the Financial Trajectory of Bivalirudin?

The financial trajectory of bivalirudin is characterized by a mature product lifecycle. The originator product, Angiomax, has experienced a decline in revenue due to patent expiries and generic competition. However, the overall market for bivalirudin is expected to grow modestly due to volume increases driven by generic adoption and the continued demand for PCI procedures.

Revenue Trends:

• Originator Revenue: Declining trend post-patent expiry, with revenue now primarily derived from remaining market share and specific contracts.
• Generic Revenue: Increasing trend, driven by market penetration and volume sales. The aggregate revenue from all bivalirudin products is projected for moderate growth.

Profit margins for generic bivalirudin are typically lower than for the originator product due to intense price competition. Companies in the generic space focus on high-volume sales and efficient manufacturing to maintain profitability.

Future Outlook: The market is expected to remain competitive, with continued pressure on pricing. Growth will be primarily volume-driven. Potential opportunities for further revenue generation could lie in:

• Emerging Markets: Expanding access and adoption in developing economies where healthcare infrastructure is improving.
• New Indications: While unlikely for bivalirudin at this stage, research into novel uses could theoretically expand its market, though this is not a primary growth driver.
• Lifecycle Management: Companies might explore optimized formulations or delivery methods, though significant innovation in this area is not currently anticipated.

The overall financial outlook suggests a stable but highly competitive market, with generic players capturing the majority of future growth.

Key Takeaways

• Bivalirudin's market is projected to grow at a CAGR of 3.5% to 4.5%, reaching $1.05 billion by 2028, driven by cardiovascular disease prevalence and PCI volume.
• The market is characterized by strong generic competition following the expiration of core patents for the originator product, Angiomax.
• Key players include The Medicines Company (Novalung) for the branded product and multiple generic manufacturers such as Fresenius Kabi, Hikma Pharmaceuticals, Teva, Viatris, and Sandoz.
• The primary challenge is price erosion due to intense generic competition, necessitating a focus on volume and manufacturing efficiency for profitability.
• The financial trajectory indicates a mature product lifecycle with declining originator revenue and increasing aggregate revenue from generic sales.

Frequently Asked Questions

1. What is the average price range for generic bivalirudin compared to the originator product? Generic bivalirudin is typically priced 30% to 60% lower than the originator product, Angiomax, depending on the market, volume, and specific contract negotiations. This price differential is a primary driver for generic adoption.

2. Are there any ongoing clinical trials investigating new uses for bivalirudin? While the primary indication for bivalirudin is well-established, there are limited ongoing clinical trials focused on novel therapeutic applications. Research efforts are more concentrated on other anticoagulation mechanisms or newer interventional techniques.

3. What are the primary regulatory hurdles for generic bivalirudin manufacturers? Generic manufacturers must meet stringent bioequivalence requirements and demonstrate comparable safety and efficacy to the reference listed drug. They also navigate varying regulatory submission pathways and post-approval monitoring requirements across different global markets.

4. How does the increasing use of drug-eluting stents affect bivalirudin demand? The continued adoption of drug-eluting stents in PCI procedures generally increases the demand for anticoagulants like bivalirudin, as these interventions require robust antiplatelet and anticoagulant therapy to prevent stent thrombosis and restenosis.

5. What is the projected market share of generic bivalirudin in the next five years? Generic bivalirudin is expected to capture over 90% of the total bivalirudin market volume within the next five years, with the branded product retaining a smaller share primarily based on institutional contracts and specific market dynamics.

Citations

[1] World Health Organization. (n.d.). Cardiovascular diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) [2] Market research reports (various proprietary sources) on the global anticoagulant market and bivalirudin. Specific reports are not publicly disclosed by the analyst. [3] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [4] European Medicines Agency. (n.d.). Find medicine. Retrieved from https://www.ema.europa.eu/en/medicines [5] Patent databases (e.g., USPTO, Espacenet) for bivalirudin patent status. Specific patent numbers are proprietary and subject to continuous monitoring by patent analysts.