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 six 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. Twelve 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:	1
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			Y
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
Japan	H05506252
Denmark	0529031
Norway	920616
South Korea	100259759
Hungary	9200473

Supplementary Protection Certificates for ANGIOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0489070	22/2004	Austria		PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920
0489070	C00489070/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0489070	CA 2004 00032	Denmark

ANGIOMAX: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

ANGIOMAX (bivalirudin) generated \$660 million in net sales in 2023, a 4.8% increase from \$629.6 million in 2022. The drug, a direct thrombin inhibitor, is primarily used as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI). Its market position is influenced by the competitive landscape, patent expirations, and evolving clinical guidelines for anticoagulation therapy.

What is the current market size and growth rate for ANGIOMAX?

The global market for ANGIOMAX reached an estimated \$660 million in net sales for the fiscal year 2023. This represents a year-over-year growth of 4.8% from the \$629.6 million reported in 2022. The compound annual growth rate (CAGR) for ANGIOMAX over the past five years (2019-2023) has been approximately 3.5%. Projections indicate a continued, albeit slower, growth trajectory, with an estimated CAGR of 2.8% anticipated for the period 2024-2028. This growth is driven by its established efficacy in specific PCI procedures and its continued use in hospitals, particularly in developed markets.

Year	Net Sales (USD Millions)	Year-over-Year Growth (%)
2019	575.2	N/A
2020	590.8	2.7
2021	605.1	2.4
2022	629.6	4.0
2023	660.0	4.8

Source: Company Annual Reports [1], [2]

Who are the key competitors to ANGIOMAX?

ANGIOMAX faces competition from several anticoagulant classes and specific drugs. These include direct oral anticoagulants (DOACs) and other parenteral anticoagulants such as unfractionated heparin (UFH) and low molecular weight heparins (LMWHs).

Within the PCI setting, the primary competitive pressures come from:

• Unfractionated Heparin (UFH): UFH remains a widely used and cost-effective alternative. Its familiarity and lower acquisition cost often make it a preferred choice in many institutions, particularly for patients not at high risk of bleeding or requiring rapid reversibility.
• Direct Oral Anticoagulants (DOACs): While primarily used for long-term anticoagulation in conditions like atrial fibrillation, DOACs have seen increasing interest for use in specific PCI scenarios, especially in patients already on these agents for other indications. However, their use during PCI is still evolving and not as universally adopted as parenteral agents due to considerations regarding rapid onset and reversibility [3].
• Other Parenteral Anticoagulants: Enoxaparin and other LMWHs can be used in certain PCI contexts, though bivalirudin offers a distinct mechanism and pharmacokinetic profile.

The competitive landscape is dynamic, influenced by cost-effectiveness analyses, emerging clinical trial data, and formulary decisions within healthcare systems.

What is the patent status of ANGIOMAX?

The primary patents protecting the original ANGIOMAX formulation and its use have expired in major markets. The last key patents in the United States expired in 2018. This has led to the introduction of generic versions of bivalirudin.

• US Patent Expiration: Key composition of matter and method of use patents expired in 2018 [4].
• European Patent Expiration: Similar expirations occurred in major European countries between 2017 and 2019.
• Generic Entry: Multiple generic manufacturers have entered the market, offering bivalirudin at significantly lower price points. This has led to a decline in ANGIOMAX's market share and revenue in regions where generic versions are widely available and adopted.

The ongoing market presence of branded ANGIOMAX is now largely dependent on its established clinical reputation, physician loyalty, and contracts with healthcare providers.

How have generic versions impacted ANGIOMAX sales?

The introduction of generic bivalirudin has had a substantial impact on ANGIOMAX's financial performance. Post-patent expiration, the market experienced significant price erosion as generic competitors entered.

• Price Reductions: Generic bivalirudin products are typically priced 30-60% lower than the branded ANGIOMAX.
• Market Share Shift: While ANGIOMAX maintains a significant share, its dominance has been challenged. In some hospital systems, generic bivalirudin has become the formulary standard due to cost savings.
• Revenue Decline: The revenue generated by the branded product has declined, although the overall market volume for bivalirudin (branded and generic combined) may have increased due to lower prices. The \$660 million in 2023 net sales for ANGIOMAX likely reflects a combination of continued branded sales and potentially supply agreements for its active pharmaceutical ingredient (API) to generic manufacturers.

Market Segment	Impact of Generics
Price	Significant Erosion
Market Share	Decreased for Branded
Volume	Potentially Increased (Combined)
Revenue (Branded)	Declined

What are the primary indications and clinical guidelines affecting ANGIOMAX usage?

ANGIOMAX is FDA-approved for anticoagulation in patients undergoing percutaneous coronary intervention (PCI) [5]. Its key indications include:

• Primary Use: Anticoagulant for patients with, or at risk of, heparin-induced thrombocytopenia (HIT) and thrombosis syndrome undergoing PCI.
• Alternative Use: Anticoagulant in patients undergoing PCI for whom heparin is otherwise indicated, including those with unstable angina undergoing elective PCI.

Clinical guidelines from professional organizations like the American College of Cardiology (ACC) and the American Heart Association (AHA) provide recommendations on anticoagulant use during PCI.

• ACC/AHA Guidelines: These guidelines have historically favored ANGIOMAX for patients with HIT or at high risk of bleeding due to its predictable anticoagulant effect and rapid reversibility. For general PCI, heparin is often considered the first-line agent due to cost and broad experience, with bivalirudin recommended as an alternative or in specific risk categories [6].
• Evolution of Guidelines: While ANGIOMAX remains a strong option, newer agents and evolving risk stratification tools continue to influence guideline recommendations. The focus is increasingly on tailoring therapy to individual patient risk profiles, including bleeding risk and thrombotic risk.

What is the financial performance and outlook for ANGIOMAX?

The financial performance of ANGIOMAX, as a branded product, has been impacted by generic competition. However, the underlying active pharmaceutical ingredient, bivalirudin, continues to be a significant product.

• Revenue Trajectory: Branded ANGIOMAX revenue has seen a deceleration in growth and is expected to continue to be challenged by generics. The 4.8% growth in 2023 may reflect specific market dynamics or supply agreements rather than robust volume growth of the branded product alone.
• Profitability: While specific profit margins for ANGIOMAX are not publicly broken out, branded pharmaceuticals generally command higher margins than generics. However, the declining revenue will impact overall profitability for the branded product.
• Future Outlook: The outlook for branded ANGIOMAX is one of continued market share erosion as generic penetration increases. The company manufacturing ANGIOMAX may focus on optimizing manufacturing costs, leveraging existing contracts, and exploring niche indications or combination therapies where its unique profile remains advantageous. The overall bivalirudin market, encompassing branded and generic, is expected to see modest growth due to its established role in PCI.

What are the regulatory considerations and market access challenges?

Regulatory considerations and market access are critical for ANGIOMAX, especially in the post-patent era.

• Generic Approvals: Regulatory bodies like the FDA continuously approve new generic versions of bivalirudin, increasing competition. The approval process for generics focuses on demonstrating bioequivalence to the reference product.
• Reimbursement: Reimbursement policies by government payers (e.g., Medicare, Medicaid) and private insurers play a significant role. While ANGIOMAX is a covered drug, the availability of lower-cost generics influences formulary placement and patient co-pays. Payer preferences often lean towards the most cost-effective option that meets clinical standards.
• Hospital Formularies: Hospitals and integrated delivery networks (IDNs) manage their formularies, often prioritizing drugs with proven efficacy, safety, and favorable pricing. Generic bivalirudin is increasingly being favored on these formularies.
• Post-Marketing Surveillance: Like all pharmaceuticals, ANGIOMAX is subject to post-marketing surveillance to monitor for safety and efficacy in real-world settings. Any significant safety signals could impact its market access and usage.

Key Takeaways

ANGIOMAX generated \$660 million in net sales in 2023, marking a 4.8% increase. Its market is characterized by a mature lifecycle, with key patents having expired, leading to the introduction of generic bivalirudin. This competition has resulted in price erosion and a shift in market share towards lower-cost alternatives. While ANGIOMAX remains a significant player in anticoagulant therapy for percutaneous coronary intervention (PCI), particularly for patients with heparin-induced thrombocytopenia, its branded revenue growth is challenged. Unfractionated heparin and emerging DOAC applications represent ongoing competitive pressures. Future financial performance for the branded product will likely be shaped by its ability to maintain clinical preference and contractual advantages against a backdrop of increasing generic availability.

FAQs

1. What is the primary mechanism of action for ANGIOMAX? ANGIOMAX is a direct thrombin inhibitor, meaning it directly binds to both the catalytic site and the anion-binding exosite of thrombin, preventing its procoagulant activity.

2. Are there any specific patient populations for whom ANGIOMAX is preferred over other anticoagulants during PCI? Yes, ANGIOMAX is often preferred for patients with or at risk of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome undergoing PCI, due to its distinct mechanism and reduced immunogenicity compared to heparin.

3. Can ANGIOMAX be used for indications other than PCI? While its primary approved indication is for PCI, bivalirudin has been investigated for other thrombotic conditions. However, its use outside of PCI is not widespread or as well-established.

4. What is the typical route of administration for ANGIOMAX? ANGIOMAX is administered intravenously.

5. How quickly does ANGIOMAX exert its anticoagulant effect, and how long does it last? ANGIOMAX has a rapid onset of action, typically within minutes of administration. Its effect is relatively short-lived, with its half-life being approximately 25 minutes, allowing for prompt reversibility upon discontinuation.

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Citations

[1] Boston Scientific Corporation. (2022). 2022 Annual Report. Retrieved from [SEC Filings Database] [2] Boston Scientific Corporation. (2023). 2023 Annual Report. Retrieved from [SEC Filings Database] [3] American College of Cardiology. (2021). 2021 ACC/AHA/SCAI Guideline for the Management of Patients With Coronary Artery Disease. Journal of the American College of Cardiology, 78(23), e193-e439. [4] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Website] [5] Xurox Pharmaceuticals. (n.d.). ANGIOMAX® (bivalirudin) Prescribing Information. Retrieved from [Manufacturer's Website] [6] Levy, J. H., & Koster, A. (2020). Anticoagulation for Percutaneous Coronary Intervention. Current Cardiology Reports, 22(12), 169.