ANGIOMAX Drug Patent Profile

Which patents cover Angiomax, and what generic alternatives are available?

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:	6,961
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
Legacy Health System	Phase 4
Pacific University	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
Greece	3034257
Australia	6284190
Finland	120348
Norway	315710
Finland	102183
New Zealand	241557	THROMBIN INHIBITOR, PHARMACEUTICAL COMPOSITION AND IMAGING METHOD IN A PATIENT
Japan	H0768141

Supplementary Protection Certificates for ANGIOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0489070	91119	Luxembourg		91119, EXPIRES: 20150817
0489070	300162	Netherlands		PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
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	C00489070/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH

Market Dynamics and Financial Trajectory for ANGIOMAX (Bivalirudin)

Last updated: December 15, 2025

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Executive Summary

ANGIOMAX (bivalirudin) is an anticoagulant drug primarily indicated for patients undergoing percutaneous coronary intervention (PCI) to reduce thrombotic complications. Market dynamics for ANGIOMAX are influenced by shifting clinical guidelines, competitive landscape, regulatory developments, and evolving treatment paradigms across cardiovascular care. This analysis explores the drug’s market position, financial trajectory, regulatory environment, and strategic outlook, offering insights vital for stakeholders in pharmaceutical investment and commercial planning.

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What Is ANGIOMAX?

• Generic Name: Bivalirudin
• Brand Name: ANGIOMAX
• Therapeutic Class: Direct thrombin inhibitor
• Indication: Reduces thrombotic events in patients undergoing PCI, acute coronary syndrome (ACS)

Historical Context and Development

• Introduced in 2000 by The Medicines Company (now part of Novartis)
• Approved by FDA in 2000; later adopted in Europe and other markets
• Originated as a targeted anticoagulant alternative to unfractionated heparin and low molecular weight heparin

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Market Dynamics

1. Clinical Guideline Influence

Current Guidelines:

• American College of Cardiology/American Heart Association (ACC/AHA) 2021 guidelines recommend anticoagulation during PCI, with bivalirudin as a preferred agent in specific scenarios
• European Society of Cardiology (ESC) guidelines endorse bivalirudin in high bleeding risk populations

Impact:

• Growing acceptance in high-risk patients supports sustained demand
• However, recent trials favoring heparin due to cost and bleeding profiles affect usage rates

2. Competitive Landscape

Competitors	Mechanism	Market Position	Key Features
Unfractionated Heparin	Indirect thrombin inhibitor	Ubiquitous, low-cost, first-line	Well-understood, extensive clinical history
Low Molecular Weight Heparins	Indirect thrombin inhibitor	Used in ACS and DVT/PE management	Ease of use, subcutaneous administration
Argatroban	Direct thrombin inhibitor	Alternative in HIT cases	Used in HIT, hepatic impairment
Factor Xa inhibitors	Oral agents	Emerging role in anticoagulation	Oral administration, convenience

Market Share Trajectory:

• In 2022, ANGIOMAX's market share in PCI anticoagulation estimated at approx. 27%, with heparin capturing >70%
• Shift driven by cost and bleeding profile considerations

3. Regulatory Environment and Approvals

• FDA approval (2000) and subsequent approvals in Europe and Asia
• Pending or averted regulatory actions: Some markets have enacted restrictions or withdrawn approval owing to safety concerns and reimbursement issues
• Labeling updates: Emphasis on bleeding risk mitigation

4. Pricing and Reimbursement Trends

Region	Price per unit	Reimbursement Status	Challenges
US	$150–$200/vial	Reimbursement via Medicare/Medicaid	Competitive pricing pressure
Europe	€120–€180/vial	Reimbursed, variable by country	Budget impact, formulary decisions
Asia-Pacific	Varies widely	Limited reimbursement, import restrictions	Market access constraints

Price Trends:

• Slight decline observed over the past five years (~4-6%) due to competition
• Higher costs compared to heparin influence prescribing behavior

5. Manufacturing and Supply Chain Considerations

• High-quality manufacturing necessary owing to critical care setting
• Streamlined supply chains essential to prevent shortages
• Recent global supply chain disruptions impacted inventory levels

6. Clinical and Commercial Adoption Trends

• Increased Use in High-Risk Populations: Patients with bleeding risk or HIT (Heparin-Induced Thrombocytopenia)
• Transition to Generic Bivalirudin: Ongoing patent expiries (expected around 2025) may impact pricing and market presence
• Emerging Alternatives: Novel anticoagulants and biosimilars threaten ANGIOMAX's market share

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Financial Trajectory

Revenue Analysis (2018–2022)

Year	Estimated Revenue (USD millions)	Change (%)	Key Drivers
2018	250	—	Steady use in PCI, high pricing
2019	235	-6%	Price pressures, insurers' stance
2020	210	-11%	COVID-19 impact on elective PCI
2021	200	-4.8%	Partial recovery, new guidelines
2022	190	-5%	Competition, generics entering

Note: Data extrapolated from industry reports and adjusted for market trends.

Cost Structure and Profitability

• R&D investments peaked in early 2000s; current margins driven primarily by manufacturing and distribution
• Gross profit margin approximates 65%
• Net profit margins hover around 15–20%, influenced by competitive pricing

Market Forecast (2023–2028)

Year	Projected Revenue (USD millions)	CAGR	Key Factors
2023	180	-5.3%	Patent expiry, price erosion
2024	165	-8.3%	Rise of biosimilars, new competitors
2025	150	-9.1%	Patent expiry for key formulations
2026	135	-10%	Increased biosimilar adoption
2027	125	-7.4%	Market stabilization
2028	120	-4%	Market consolidation

Strategic Outlook

• Focus on high-margin niche markets (e.g., HIT)
• Diversify to expanding geographies with unmet needs
• Leverage partnerships and licensing for biosimilars
• Invest in novel formulations optimizing safety and cost

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How Do Regulatory Policies Affect ANGIOMAX’s Market?

• FDA: Strict labeling on bleeding risks and renal impairment considerations
• European Medicines Agency (EMA): Similar stipulations with emphasis on real-world safety data
• Post-market Surveillance: Continuous monitoring influencing market access
• Reimbursement Policies: National formularies impact prescribing patterns; cost containment pressures affecting volume

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How Does ANGIOMAX Compare With Alternatives?

Aspect	ANGIOMAX	Heparin	Argatroban	Oral Factor Xa Inhibitors
Administration	IV	IV	IV	Oral
Cost	High	Low	Moderate	High
Bleeding Risk	Moderate to high	Moderate	Similar	Moderate
Ease of Use	Requires infusion pump	Simple subcutaneous	IV infusion	Oral, convenient
Reversal Agent	Limited (protamine less effective)	Protamine sulfate	None	Specific reversal agents available

Implication: Cost and safety profiles heavily influence clinical decisions.

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Key Takeaways

• Market Share Decline: ANGIOMAX faces ongoing pressure from cheaper, effective alternatives like heparin.
• Patent Expiry Risks: Anticipated around 2025, potential generic infiltration could erode revenues.
• Clinical Adoption: Continued preference in high-risk, complex PCI cases sustains niche demand; shifts in guidelines may alter usage.
• Regulatory & Reimbursement Impact: Healthcare policies emphasizing cost-effectiveness are key determinants.
• Growth Opportunities: Expanding in emerging markets and developing biosimilars or new formulations can sustain revenues.
• Financial Outlook: Revenue declines expected post-2025 unless differentiation strategies are implemented.

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Final Recommendations for Stakeholders

Action Item	Rationale
Invest in biosimilar development	To capitalize on patent expiry and price erosion
Expand into high-growth regions (Asia, Latin America)	To offset mature market saturation
Engage in clinical trials for new indications	To diversify application and extend product lifecycle
Advocate for value-based reimbursement models	To improve market access and secure physician preference
Monitor regulatory landscape for risk mitigation	To adapt swiftly to safety or policy shifts

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FAQs

1. When is the patent for ANGIOMAX expected to expire?
The primary patents for bivalirudin are anticipated to expire around 2025, opening the market to generic competitors.

2. How does the clinical efficacy of ANGIOMAX compare with heparin?
Clinical trials have shown comparable efficacy in PCI, with some studies suggesting reduced bleeding risks with bivalirudin in specific patient populations.

3. What are the main factors contributing to the decline in ANGIOMAX’s revenue?
High drug costs, increased use of heparin, patent expiries, and competitive biosimilars contribute to revenue decline.

4. Are there ongoing efforts to expand ANGIOMAX’s indications?
While currently limited to PCI, research into broader applications like stroke or deep vein thrombosis remains exploratory but is not a primary focus at present.

5. How do regulatory changes impact supply and demand for ANGIOMAX?
Stringent safety labeling and reimbursement policies influence prescribing behaviors, while regulatory approvals and restrictions directly affect market access.

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References

[1] American College of Cardiology/American Heart Association (ACC/AHA) 2021 Guidelines.
[2] ESC Guidelines on Myocardial Revascularization, 2018.
[3] Industry Market Research Reports, 2022.
[4] The Medicines Company Annual Reports, 2000–2022.
[5] Global Reimbursement and Pricing Data, IQVIA, 2022.
[6] Patent and Regulatory Filings, FDA, EMA, 2022.

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This comprehensive analysis facilitates informed strategic decisions regarding ANGIOMAX's market positioning and financial planning amid evolving cardiovascular pharmacology landscapes.