Bivalirudin - Generic Drug Details

What are the generic drug sources for bivalirudin and what is the scope of patent protection?

Bivalirudin is the generic ingredient in four branded drugs marketed by Sandoz, Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Meitheal, Mylan Institutional, Shuangcheng, 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.

Thirteen 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
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	78
Patent Applications:	7,911
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
Chibi People's Hospital	NA
Laohekou First Hospital	NA
The Central Hospital of Huanggang	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
Hospira	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090816-001	Jul 14, 2015		DISCN	No	No
Hainan Poly	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	213078-001	May 28, 2021	AP	RX	No	No
Baxter Hlthcare Corp	BIVALIRUDIN IN 0.9% SODIUM CHLORIDE	bivalirudin	SOLUTION;INTRAVENOUS	208374-001	Dec 21, 2017		DISCN	Yes	No
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
Apotex	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	204876-001	Jul 6, 2017		DISCN	No	No
Mylan Institutional	BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	202471-001	Jun 1, 2018	AP	RX	No	No

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 (Angiomax) Market Dynamics and Financial Trajectory (US and Global)

Last updated: July 6, 2026

Executive summary: Bivalirudin’s market is shrinking under structural pressure from generic competition and guideline-driven preference shifts in percutaneous coronary intervention (PCI). In the US, the Angiomax brand’s sales peak is past as generic hirudin-like and heparin-based pathways captured share where clinically interchangeable. The financial trajectory since maturity shows declining revenues, with any stabilization tied to institutional formulary retention, acute-care contract renewals, and patient-access channels rather than new clinical expansion. Patent and exclusivity-driven protections are largely expired in major markets, so post-generic dynamics are dominated by pricing, hospital contracting, and procurement compliance.

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How big is the bivalirudin market and what are the key drivers of demand?

Demand base: Bivalirudin is used primarily in cardiology for anticoagulation during PCI and related catheter-based procedures, where it has been positioned as an option to reduce bleeding risk versus unfractionated heparin in select settings. The practical buying unit is hospital cath lab and peri-procedural pharmacy contracting rather than outpatient prescription volume.

Core demand drivers

• PCI procedure volume and case mix (elective vs ACS, left main, complex PCI, rotational atherectomy use patterns).
• Institutional preference for anticoagulant strategy during cath lab workflows.
• Switching costs: inventory, order sets, nursing protocols, and familiarity.
• Safety and monitoring burden perceptions, especially around heparin-induced thrombocytopenia (HIT) risk management.

Core demand inhibitors

• Competitive substitution by unfractionated heparin with standard protocols and by newer anticoagulant approaches in catheterization pathways.
• Post-generic price compression once multiple manufacturers enter.
• Guideline and formulary changes that reduce “default” use outside niche populations.

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What is the financial trajectory of Angiomax (bivalirudin) and how has revenue trended?

Trajectory (high-level pattern): Bivalirudin’s revenue path follows a classic branded biologically derived anticoagulant profile: growth through adoption, plateau as formularies standardized, then decline as exclusivity ended and generics entered. Post-entry financial performance typically depends less on incremental clinical adoption and more on:

• how aggressively hospitals switch to lower-priced entrants,
• whether a “preferred” generic remains stable across contract cycles, and
• whether supply continuity issues arise.

What controls year-to-year sales

• US acquisition price and ASP declines after generic competition.
• Contracting outcomes in large integrated delivery networks and group purchasing organizations.
• Inventory behavior during manufacturing disruptions and allocation periods (when they occur).

Investor and competitor lens

• Bivalirudin is usually treated as a cash-flow commodity for generic entrants rather than an R&D frontier drug.
• The incumbent’s financial trajectory after generic entry is dominated by margin and contract retention, not by new SKU launches.

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Where is bivalirudin sold and who buys it: hospital contracts, IDNs, or specific geographies?

US procurement center of gravity

• The dominant purchasing channel is hospital cath labs, cath lab pharmacies, and peri-procedural anticoagulation protocols.
• Coverage and reimbursement are less likely to be a binding growth driver than contract pricing and product availability.

Global footprint

• Bivalirudin’s global market is shaped by approvals by country and the extent of local generic infiltration.
• Developed markets with established hospital tender systems tend to switch faster after generic availability.

Commercial implication

• The “winner” post-generic competition is typically the supplier that holds preferred status in:
  • IDNs,
  • group purchasing agreements,
  • state or national tender cycles,
  • and hospital distribution arrangements.

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What do post-generic price dynamics look like for bivalirudin?

Pricing mechanics

• After generic entry, bivalirudin pricing compresses quickly due to:
  • high substitutability in clinical workflow,
  • procurement standardization on INN (international nonproprietary name),
  • and payer and clinician neutrality once bioequivalence/PK similarity is accepted.

Margin pressure

• Branded manufacturers face declining gross margin because they either match pricing or lose formulary placement.
• Generic entrants compete on:
  • tender wins,
  • allocation and supply reliability,
  • and net price after rebates and distribution discounts.

Typical outcomes

• Reduced unit revenue per vial.
• Greater volume volatility tied to contract renewals rather than demand growth.

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What patent and exclusivity protections historically mattered for bivalirudin, and when did they expire?

Exclusivity category: The relevant framework for bivalirudin includes FDA listed drug exclusivity for the branded reference product plus patent estate covering the active ingredient manufacturing, formulations, and method claims. Once core protections expire and generics are approved, the market becomes pricing-driven.

Outcome: For business planning, bivalirudin is treated as post-exclusivity in the US and other developed markets. Any remaining residual patent coverage tends to shift from “block generic entry” to “influence specific formulations, pack sizes, or manufacturing changes,” which has limited effect on broad hospital purchasing unless tied to a specific product form.

(Patent-by-patent expiration timelines and Orange Book status are not included here because this request does not provide the FDA NDA/ANDA identifier or reference product label variant needed for a complete, accurate mapping.)

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What is the Orange Book status of bivalirudin and which patents are listed?

Orange Book listing relevance

• A complete Orange Book status view requires:
  • the NDA number and strength/formulation listed,
  • the exact reference listed drug (RLD) name (brand vs authorized generic),
  • and the patent list by US claims and exclusivity type.

Business use

• Orange Book drives:
  • Paragraph IV risk analysis,
  • infringement trigger points,
  • and launch timing for ANDA filers.

(No Orange Book dataset is included in the prompt. Without the RLD/NDA precision needed for accuracy, a complete Orange Book patent table would risk misstatement.)

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How many generics are in the market for bivalirudin, and what are the typical launch scenarios?

Launch scenarios after approval

• Immediate tender wins if the supplier is positioned as lowest net cost.
• Slow adoption where hospitals have procurement compliance constraints or require switching education.
• Substitute use if stocked alternatives exist.

Key scenario drivers

• Product supply stability.
• Label equivalence acceptance by hospital pharmacists and therapeutics committees.
• Tender structure: award to one supplier vs multi-award.

Financial forecast implication

• Revenue for remaining brand exposure becomes more contract-dependent and less procedure-volume-dependent.
• Generic entrants’ revenue correlates with tender share rather than innovation.

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What impact does patent litigation have on bivalirudin market timing and entry?

Litigation role

• In mature anticoagulants like bivalirudin, litigation primarily affects:
  • whether launch is delayed,
  • whether authorized generics appear,
  • and whether particular manufacturing changes are permitted.

Post-entry reality

• Even when litigation delays some entrants, the market usually transitions quickly once courts settle or when exclusivity/patent barriers lift.

(A litigation timeline requires specific case identifiers and court dockets tied to the NDA/RLD patent list. Those are not supplied in the request, so a case-accurate account cannot be produced.)

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How does bivalirudin compare with alternatives in PCI and anticoagulation strategy?

Clinical positioning

• Bivalirudin is anticoagulant therapy used in PCI workflows.
• Competitors include unfractionated heparin-based strategies and other anticoagulant regimens used in cardiology protocols.

Commercial comparison

• When clinicians view alternatives as therapeutically equivalent within protocol, pharmacy adoption shifts toward lowest net price.
• If bivalirudin maintains an advantage in bleeding risk or workflow simplicity for specific populations, formulary retention can persist, but only if those populations are large enough to justify contracted pricing.

Procurement impact

• Even modest relative cost advantages can drive substitution at scale.

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What are the main formulation and manufacturing risks that influence bivalirudin availability and supply costs?

Manufacturing sensitivity

• Bivalirudin is a synthetic peptide anticoagulant with production complexity tied to peptide synthesis and purification steps.
• Supply continuity impacts hospital purchasing decisions, especially under strict cath lab scheduling.

Business impacts

• Supply constraints lift net prices temporarily for the constrained supplier.
• Stock-outs lead to rapid switching to alternatives, which can become sticky and reduce rebound sales after supply normalizes.

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Biosimilar risk: is bivalirudin exposed to biosimilar competition?

Answer: No. Bivalirudin is not a biologic requiring biosimilar pathways; it is a small peptide drug product. Competition is via generic chemical peptide manufacture under ANDA frameworks rather than biosimilar development.

Commercial implication

• Market dynamics are dominated by generic entrants, not biosimilars.

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Key financial sensitivity: what metrics best predict bivalirudin’s next revenue year?

Forecast indicators

• US hospital contract renewal outcomes and net pricing shifts.
• Market share of preferred supplier among top IDNs.
• ASP trends and vial-level price erosion rate.
• Volume changes driven by cath lab procedural volume, not new patient populations.
• Supply continuity metrics (fill-rate, allocation events).

Why these matter

• Bivalirudin has limited innovation runway once exclusivity ends.
• Revenue is a function of procedure demand and contracted share under commodity-like pricing.

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Key Takeaways

• Bivalirudin’s market has transitioned from adoption-driven growth to pricing- and contracting-driven decline post-exclusivity.
• Financial trajectory is mainly determined by generic competition, ASP compression, and formulary/tender retention rather than new clinical expansion.
• Competitive advantage, when it exists, is procedural workflow fit and institution-specific protocol decisions that can delay or limit full generic switching.
• Future revenue performance is most sensitive to net price and contract share in US hospital networks, with supply reliability acting as a secondary driver.

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FAQs

1) When does generic bivalirudin typically gain share after ANDA approval?
Often quickly in tender-driven hospital systems, but adoption can lag if cath lab order sets and nursing protocols require change management.

2) Does bivalirudin face biosimilar competition risk?
No, competition is through generic peptide products rather than biosimilar pathways.

3) What drives institution-level switching between bivalirudin and alternatives for PCI?
Net cost after contracting, clinical protocol alignment, and perceived bleeding-risk workflow differences.

4) Which hospital purchasing models affect bivalirudin revenue most?
IDN formularies and group purchasing organization tenders, where award structures determine preferred supplier volume.

5) What manufacturing events can move bivalirudin market pricing temporarily?
Supply disruptions, allocation, and limited distribution capacity can briefly change net pricing and shift volumes to alternative anticoagulants.

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References

(No sources were provided in the prompt, and no Orange Book/NDA identifiers or FDA label data were supplied. Inline citations and a reference list cannot be completed without sourceable materials.)