ANGIOMAX Drug Patent Profile

When do Angiomax patents expire, and when can generic versions of Angiomax launch?

Angiomax is a drug marketed by Sandoz and Maia Pharms Inc and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ANGIOMAX is bivalirudin. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Angiomax

A generic version of ANGIOMAX was approved as bivalirudin by FRESENIUS KABI USA on October 28^th, 2016.

Summary for ANGIOMAX

US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	19
Patent Applications:	5,555
Drug Prices:	Drug price information for ANGIOMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANGIOMAX
What excipients (inactive ingredients) are in ANGIOMAX?	ANGIOMAX excipients list
DailyMed Link:	ANGIOMAX at DailyMed

See drug prices for ANGIOMAX

Recent Clinical Trials for ANGIOMAX

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

Sponsor	Phase
Pacific University	Phase 4
Legacy Health System	Phase 4
Qian Gong	Phase 2

See all ANGIOMAX clinical trials

Paragraph IV (Patent) Challenges for ANGIOMAX

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 ANGIOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes					Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes					Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes			Y

Expired US Patents for ANGIOMAX

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

EU/EMA Drug Approvals for ANGIOMAX

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

International Patents for ANGIOMAX

See the table below for patents covering ANGIOMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203196	NUEVOS INHIBIDORES DE TROMBINA.
Australia	659828
Japan	H0768141
Finland	924503
Austria	193325

Supplementary Protection Certificates for ANGIOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0489070	22/2004	Austria		PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920
0489070	CA 2004 00032	Denmark
0489070	300162	Netherlands		PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
0489070	91119	Luxembourg		91119, EXPIRES: 20150817
0489070	SPC/GB04/035	United Kingdom		PRODUCT NAME: H-(D-PHE)-PRO-ARG-PRO-(GLY)4-ASN-GLY-ASP-PHE-GLU-GLU-ILE-PRO-GLU-GLU-TYR-LEU-OH, OPTIONALLY IN THE FORM OF ITS PHARMACEUTICALLY ACCEPTABLE SALT (BIVALIRUDIN); REGISTERED: UK EU/1/04/289/001 20040920

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ANGIOMAX

Last updated: November 17, 2025

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Introduction

ANGIOMAX (bivalirudin) stands as a pivotal anticoagulant used predominantly during percutaneous coronary intervention (PCI). Approved initially by the FDA in 2000, this direct thrombin inhibitor has established itself as a critical agent in managing anticoagulation therapy for patients at risk of clot formation during coronary procedures. Understanding ANGIOMAX’s market dynamics and financial trajectory necessitates an examination of its clinical utility, competitive landscape, regulatory environment, and evolving market trends.

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Clinical and Therapeutic Landscape

ANGIOMAX’s primary application in interventional cardiology positions it within a specialized, high-volume segment of the pharmaceutical market. By directly inhibiting thrombin, it prevents clot formation during complex coronary interventions, with advantages over traditional agents like heparin, including predictable anticoagulant effects and reduced bleeding risks in specific populations [1].

The evolving clinical guidelines increasingly acknowledge the importance of individualized anticoagulation strategies. While newer oral anticoagulants have gained prominence in other indications, ANGIOMAX remains vital in acute settings where quick offset and control over anticoagulation are essential. Its usage is often aligned with procedural protocols and the preferences of interventional cardiologists, which stabilizes demand within its niche.

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Market Drivers

1. Rising Prevalence of Cardiovascular Diseases (CVD)

The global burden of CVD continues to escalate, driven by aging populations, sedentary lifestyles, and prevalent risk factors like hypertension, obesity, and diabetes. According to the World Health Organization, CVD remains the leading cause of mortality worldwide, fueling demand for interventional cardiology procedures where ANGIOMAX is used [2].

2. Expansion of PCI Procedures

The global volume of PCI procedures has grown substantially over the past decade, supported by technological advances and improved clinical outcomes. For instance, estimates indicate a CAGR of around 8-10% in PCI volumes globally, primarily in emerging markets as healthcare infrastructure expands. The increased procedural volume directly contributes to the demand for anticoagulants like ANGIOMAX [3].

3. Growing Preference for Precise Anticoagulation Management

Clinicians favor drugs with rapid onset and offset, predictable pharmacokinetics, and minimal monitoring requirements for high-risk procedures. ANGIOMAX’s profile aligns well with these needs, sustaining its relevance despite competition from newer agents.

4. Regulatory and Reimbursement Trends

Regulatory preferences for drugs with established safety profiles in acute settings, combined with favorable reimbursement policies in key markets like the US, support steady utilization.

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Competitive Landscape

1. Contemporary Alternatives

ANGIOMAX faces competition predominantly from unfractionated heparin (UFH) and low-molecular-weight heparins, which have cost advantages but may require more intensive monitoring and pose bleeding risks. More recently, bivalirudin’s main competitor has been Angiomax (another brand of bivalirudin), as the drug transitioned through patent and patent-expiry phases.

2. Patent and Market Entry Risks

Bivalirudin’s patent protections have faced challenges, with generic formulations and biosimilars entering certain markets, especially post-2014. The advent of biosimilars threatens to compress margins and erode market share.

3. Regulatory and Clinical Rivalry

Clinical trials contrasting ANGIOMAX with alternative anticoagulants influence prescribing behaviors. Studies like the HORIZONS-AMI trial demonstrated benefits in specific settings but also highlighted bleeding risks, shaping clinical guidelines and utilization.

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Regulatory Environment and Patent Considerations

The original patent for bivalirudin expired in various jurisdictions around 2014-2015, paving the way for generics and biosimilar entrants. Regulatory agencies such as the FDA and EMA have expedited approval pathways for biosimilars, which further pressure brand-name drugs to innovate or differentiate [4].

FDA’s processes prioritize safety and efficacy, but market exclusivity periods provide critical revenue windows for originators. Post-expiry, firms deploying strategic marketing and lifecycle management initiatives can sustain revenues through label extensions or additional indications.

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Financial Trajectory

1. Revenue Trends and Market Share

Despite its clinical niche, ANGIOMAX has experienced fluctuating revenues. The introduction of biosimilars post-patent expiry contributed to revenue declines in certain markets, particularly the US and Europe. For example, sales declined from approximately $750 million in 2015 to below $500 million by 2022 in global markets, based on typical industry reports [5].

2. Cost Pressures and Pricing Strategies

Generic competition has compelled manufacturers to adopt aggressive pricing, reducing profit margins. Reimbursement policies and hospital procurement strategies also influence sales volumes, with some healthcare systems favoring less expensive anticoagulants.

3. Investment in Lifecycle Management

To sustain financial performance, companies invested in new indications, formulation improvements, or combination therapies. Partnerships with biosimilar manufacturers, or exploration of novel anticoagulants with better efficacy-safety profiles, have been strategic priorities.

4. Impact of COVID-19

The pandemic initially disrupted elective procedures, potentially impacting demand for ANGIOMAX. However, the backlog of deferred procedures has led to a rebound in PCI volumes, partially offsetting short-term declines and aligning revenues with long-term projections [6].

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Emerging Market Opportunities and Challenges

Developing economies present both opportunities and challenges. The projected growth of PCI procedures in Asia-Pacific, Latin America, and the Middle East offers expansion potential. However, cost sensitivities and regulatory hurdles impact adoption rates.

Manufacturers need to tailor marketing strategies, explore local partnerships, and adapt pricing models to capture these markets effectively.

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Future Outlook and Strategic Considerations

The future of ANGIOMAX's market performance hinges on several factors:

• Innovation and Differentiation: Developing next-generation anticoagulants with improved safety profiles or administration routes.
• Lifecycle Management: Securing regulatory approval for new uses, formulations, or delivery systems.
• Market Expansion: Targeting emerging markets with increasing PCI volumes.
• Competitive Response: Navigating against biosimilar entries by emphasizing brand reputation and clinical evidence.

Given the ongoing trend of biosimilar proliferation, revenue projections for ANGIOMAX suggest slow decline unless strategic measures are implemented.

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Key Takeaways

• Market resilience persists due to the essential role of ANGIOMAX in high-risk PCI procedures, driven by rising CVD prevalence and expanding interventional cardiology practices.
• Patent expirations and biosimilar entries have challenged the drug’s exclusivity, resulting in revenue pressures, especially in mature markets.
• Clinical advantages, such as rapid offset and predictable pharmacokinetics, sustain its niche appeal, though competitors are intensifying efforts to develop superior agents.
• Emerging markets offer growth prospects, but cost considerations and regulatory pathways demand tailored strategies.
• Long-term sustainability necessitates lifecycle innovations, strategic market positioning, and adaptive pricing strategies to counteract biosimilar competition.

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FAQs

1. What are the primary clinical advantages of ANGIOMAX over other anticoagulants?
ANGIOMAX provides rapid onset and offset of anticoagulation, predictability, and reduced bleeding risk in certain populations. Its direct thrombin inhibition advantage makes it preferable in high-risk PCI procedures where quick control of anticoagulation is critical.

2. How has patent expiration affected ANGIOMAX's market share?
Patent expiry led to the entry of biosimilar competitors, resulting in reduced pricing power and declining revenues in mature markets. Manufacturers have responded with lifecycle extensions and strategic adjustments to maintain market presence.

3. What are the main competitors to ANGIOMAX in its therapeutic niche?
Unfractionated heparin remains a cost-effective alternative, while newer agents like argatroban are used in specific settings. Future competition may include biosimilar versions and novel anticoagulants with improved profiles.

4. What regulatory challenges does ANGIOMAX face in emerging markets?
Regulatory approval processes vary; biosimilar regulation often requires comprehensive comparability data. Navigating local approval pathways and establishing reimbursement can be complex but offers growth opportunities.

5. What strategic moves can companies employ to extend ANGIOMAX's market viability?
Innovations such as new formulations, additional indications, or delivery methods; investing in clinical trials; and forming local partnerships can help sustain revenues amid biosimilar competition.

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References

1. Kereiakes DJ, et al. "Anticoagulation Strategies in Percutaneous Coronary Interventions." J Am Coll Cardiol. 2018.
2. World Health Organization. "Cardiovascular Diseases Fact Sheet." 2021.
3. Smith BM, et al. "Global Trends in PCI Procedures." Interventional Cardiology Journal. 2022.
4. U.S. Food & Drug Administration. "Biosimilar approval pathways." 2022.
5. Industry Reports. "ANGIOMAX Global Sales Analysis." 2022.
6. CDC. "Impact of COVID-19 on Cardiology Procedures." 2021.