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
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

ANGIOMAX is protected by two US patents.

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	7,582,727*PED				Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	12,472,224		Y
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	AP	RX	Yes	Yes	7,598,343*PED				Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	11,903,993
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	11,992,514		Y
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	11,918,622

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	H0768141
Finland	120348
Hungary	T65675
Australia	1362192
Taiwan	222642
Hong Kong	1001562

Supplementary Protection Certificates for ANGIOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0489070	300162	Netherlands		PRODUCT NAME: BIVALIRUDINE; FIRST REGISTRATION,DATE: EU/1/04/289/001, 20040920
0489070	CA 2004 00032	Denmark
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	C00489070/01	Switzerland		FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0489070	22/2004	Austria		PRODUCT NAME: BIVALIRUDIN UND TRIFLUORACETAT DAVON; REGISTRATION NO/DATE: EU/1/04/289/001 20040920

Angiomax (bivalirudin): market dynamics and financial trajectory

Last updated: April 26, 2026

Angiomax is the brand of bivalirudin, a direct thrombin inhibitor used primarily in cardiology settings such as percutaneous coronary intervention (PCI). The commercial trajectory is dominated by (1) mature market dynamics, (2) competitive pressure from cheaper anticoagulation options and procedural practice shifts, and (3) the pipeline reality for the originator: the product is already in late life, and incremental new indications or formulation advances have limited reach relative to overall growth markets.

What drives Angiomax demand in the market?

Angiomax demand is closely tied to cardiology procedure volumes, especially PCI and related thrombotic-risk pathways. Its use depends on guideline-consistent adoption and clinician preference in settings where bleeding risk management is critical.

Key demand drivers:

• Procedure mix and volume
  Use correlates with PCI volumes and with site-level protocols that select anticoagulation strategy per patient risk. Mature penetration means growth is incremental and mostly tied to procedural throughput rather than net-new patient populations.

• Bleeding-risk management versus alternatives
  Clinicians weigh bleeding risk, monitoring burden, and reversibility/practicality across anticoagulant options. Angiomax’s clinical positioning relies on anticoagulation control with predictable management relative to some comparators, but it operates in a payer environment focused on cost.

• Hospital formulary control
  Formularies and group purchasing organizations influence uptake. Even where clinical preference exists, formulary decisions often track relative acquisition cost and contracted pricing.

• Competition from low-cost anticoagulation and practice patterns
  In a mature interventional cardiology market, competitors include established anticoagulation regimens that can be less costly and already embedded in standard care pathways. These products compress Angiomax’s growth and limit pricing power.

What does Angiomax’s competitive landscape look like?

Angiomax is exposed to competition at two levels:

1. Drug-class substitution inside anticoagulation pathways
   Alternative anticoagulants and procedural regimens can displace bivalirudin in parts of the PCI pathway depending on bleeding risk, protocol design, and local experience.

2. Economic substitution through contracting
   Contract pricing and tender outcomes often decide formulary share. In mature hospital markets, price becomes a stronger determinant than marginal clinical differences.

The outcome is persistent share pressure and limited ability to sustain premium pricing over time.

How has Angiomax financial performance likely evolved given product life-cycle dynamics?

Angiomax’s financial trajectory follows a late-life branded product pattern:

• Growth decelerates as penetration saturates
  When a product reaches high standard-of-care adoption, the market stops expanding from incremental new accounts and begins expanding mainly through procedure volume growth and periodic protocol changes.

• Revenue volatility tracks procedure volumes and payer contracting cycles
  Hospital procurement cycles can create revenue step-changes. Growth can be capped even when underlying cardiology volumes rise.

• Pressure increases with competitive pricing and guideline-driven protocol standardization
  Over time, payer and hospital decision-makers re-optimize procurement, pushing utilization toward lower cost options where clinically acceptable.

This overall structure tends to produce a profile where revenues plateau or decline slowly in real terms, with occasional rebounds driven by short-term contracting outcomes or temporary protocol shifts.

What are the patent and exclusivity realities that shape long-run economics?

Angiomax’s economics are heavily influenced by the maturity of exclusivity and the presence of generic or authorized competitor exposure. Bivalirudin is a biologic-like small molecule peptide drug; manufacturing and regulatory status drive entry pathways. The market dynamics reflect an environment where long-term branded pricing leverage is constrained once exclusivity weakens.

Key implication for financial trajectory

Once exclusivity erodes or generic competition strengthens, revenue typically transitions from branded premium pricing to price erosion, with the brand retaining only its strongest accounts. That dynamic limits long-range upside and forces the originator to rely on incremental usage, contracts, and any remaining differentiation.

Where does Angiomax sit in the payer and hospital cost equation?

Hospital adoption depends on the balance between total procedural cost and clinical risk management. Angiomax’s value proposition is strongest where bleeding reduction and workflow manageability translate into measurable downstream benefits for the hospital, such as reduced complications and shorter time-to-hemostasis management.

In payer settings that focus on direct drug acquisition and episode-level reimbursement, the brand is pressured to compete against lower cost regimens. This shifts the market from broad protocol adoption to selective use in higher-risk cohorts or where hospital teams have negotiated favorable pricing.

How do procurement and tender cycles affect revenue timing?

Revenue outcomes in hospital-heavy products often depend on contract timing more than day-to-day demand:

• Tender wins can lift share briefly even in a mature category.
• Tender losses can quickly unwind volume because hospitals consolidate purchasing.
• Switching costs are moderate in many PCI anticoagulation pathways, which accelerates displacement when contracts change.

The result is a financial trajectory with uneven quarter-to-quarter changes, while the multi-year trend trends downward or flat once generics or lower-cost alternatives gain traction.

What financial trajectory should investors expect for Angiomax specifically?

Given its mature, late-life nature and the structural forces described above, the expected trajectory is:

• Near-term: stable to modestly pressured revenues as procedural volume grows but utilization shifts and price competition cap growth.
• Medium-term: continued margin compression if discounting and competitive contracting persist.
• Long-term: branded revenue decline as substitution accelerates and the brand loses share in favor of lower-cost alternatives.

This pattern is typical for established anticoagulants after exclusivity and strong competitive pressure reach equilibrium in hospital formularies.

Competitiveness and pricing leverage: a practical read-through

For Angiomax, pricing leverage is constrained by:

• payer sensitivity to acquisition cost
• hospital protocol standardization
• availability of substitutes
• contracting dynamics

In such markets, the brand’s ability to sustain premium pricing is limited. Commercial results typically depend more on managed access and contract structure than on new-to-market expansion.

Key market dynamics by segment

PCI-centric usage

• Volumes anchor demand.
• Competitive anticoagulant regimens can displace bivalirudin when protocols optimize for cost and workflow.

Bleeding-risk selective use

• Helps maintain a residual high-value cohort.
• Still subject to contracting and comparative protocol updates.

Formulary-driven utilization

• High sensitivity to tenders.
• Share can change quickly after procurement renegotiations.

What does the Angiomax financial path imply for R&D planning or investment positioning?

A mature branded anticoagulant creates limited room for large revenue growth unless:

• a new indication opens a different care setting with separate reimbursement channels, or
• a formulation or delivery improvement changes workflow costs enough to overcome payer pushback, or
• a combination strategy materially expands eligible patient populations.

Without these, the financial trajectory remains dominated by price and share dynamics in a mature category.

Key Takeaways

• Angiomax demand is anchored to PCI and bleeding-risk management, but the market is mature and growth is mostly incremental through procedure volumes.
• Competitive pressure and hospital contracting constrain pricing power, leading to plateau-to-decline dynamics over time.
• Financial outcomes are shaped more by formulary and tender outcomes than by strong net-new patient expansion.
• Long-run upside depends on rare structural levers (new reimbursed indications, meaningful differentiation, or favorable contracting), not routine protocol drift.

FAQs

1) What products compete most directly with Angiomax in PCI workflows?

Direct competition comes from other anticoagulant regimens used in PCI and from established alternatives embedded in procedural protocols. Competition is amplified by hospital contracting and cost containment.

2) Why does Angiomax’s revenue tend to plateau or decline in mature markets?

Because utilization saturates, and contracting shifts the balance toward lower-cost options where clinically acceptable, compressing price and share.

3) What has the biggest impact on quarter-to-quarter Angiomax results?

Hospital formulary decisions tied to tender cycles, which can shift volume quickly even when underlying procedure volumes are stable.

4) Does bleeding-risk selection support Angiomax in the market?

Yes, selective use in higher bleeding-risk cohorts can sustain residual demand, but it is still subject to payer and formulary cost pressures.

5) What would most likely change Angiomax’s financial trajectory upward?

A new, clearly reimbursed care setting or an innovation that changes total procedural cost or workflow enough to overcome price pressure and protocol standardization.

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References

[1] Food and Drug Administration. “Angiomax (bivalirudin) Prescribing Information.” FDA label database.
[2] European Medicines Agency. “Angiox/Angiomax (bivalirudin) Product Information.” EMA product documents.
[3] Centers for Medicare & Medicaid Services. National Coverage Determinations and reimbursement frameworks for cardiovascular procedures (general reimbursement context).
[4] Clinical guidance documents on anticoagulation during PCI (society guidelines covering anticoagulant selection and bleeding risk management).