CANGRELOR - Generic Drug Details

What are the generic sources for cangrelor and what is the scope of freedom to operate?

Cangrelor is the generic ingredient in two branded drugs marketed by Gland and Chiesi, and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cangrelor has seventy-four patent family members in twenty-four countries.

There are three drug master file entries for cangrelor. Two suppliers are listed for this compound.

Summary for CANGRELOR

International Patents:	74
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	31
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CANGRELOR
What excipients (inactive ingredients) are in CANGRELOR?	CANGRELOR excipients list
DailyMed Link:	CANGRELOR at DailyMed

Recent Clinical Trials for CANGRELOR

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

Sponsor	Phase
IRCCS San Raffaele	PHASE2
Federico II University	Phase 4
Mercy Health Ohio	Phase 3

See all CANGRELOR clinical trials

Pharmacology for CANGRELOR

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for CANGRELOR

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for CANGRELOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KENGREAL	For Injection	cangrelor	50 mg/vial	204958	2	2019-06-24

US Patents and Regulatory Information for CANGRELOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes			Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes			Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes			Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes

Expired US Patents for CANGRELOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015

EU/EMA Drug Approvals for CANGRELOR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A.	Kengrexal	cangrelor	EMEA/H/C/003773Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.	Authorised	no	no	no	2015-03-23

International Patents for CANGRELOR

Country	Patent Number	Title	Estimated Expiration
Brazil	112015022070	métodos para tratar, reduzir a incidência de, e/ou prevenir eventos isquêmicos
European Patent Office	3244900	FORMULATIONS PHARMACEUTIQUES COMPRENANT DU CANGRELOR DE HAUTE PURETÉ ET LEURS PROCÉDÉS DE PRÉPARATION ET D'UTILISATION (PHARMACEUTICAL FORMULATIONS COMPRISING HIGH PURITY CANGRELOR AND METHODS FOR PREPARING AND USING THE SAME)
Colombia	2017006958	Formulaciones farmacéuticas que comprenden cangrelor de alta pureza y métodos para la preparación y uso de los mismos
Eurasian Patent Organization	201270617	СПОСОБЫ ЛЕЧЕНИЯ ИЛИ ПРЕДОТВРАЩЕНИЯ ТРОМБОЗА СТЕНТА
China	115990138	包含高纯度坎格雷洛的药物制剂以及制备和使用它们的方法 (Pharmaceutical formulations comprising high purity cangrelor and methods of making and using same)
South Korea	102440847

Supplementary Protection Certificates for CANGRELOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007094	15C0060	France		PRODUCT NAME: CANGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,NOTAMMENT UN SEL TETRASODIQUE; REGISTRATION NO/DATE: EU/1/15/994/001 20150323

Market Dynamics and Financial Trajectory for Cangrelor

Last updated: July 30, 2025

Introduction

Cangrelor, marketed as Kengreal, is an intravenous platelet aggregation inhibitor developed by The Medicines Company (acquired by Novartis in 2020). Approved by the U.S. Food and Drug Administration (FDA) in 2015, cangrelor is indicated for use as an adjunct to percutaneous coronary intervention (PCI) to reduce thrombotic cardiovascular events, such as death, myocardial infarction, or ischemia-driven revascularization [1]. Its pharmacological profile as a rapid-onset, reversible ADP receptor antagonist positions it uniquely within acute coronary syndromes (ACS) treatment protocols.

Understanding cangrelor's market dynamics entails analyzing its current positioning, competitive landscape, regulatory environment, and financial prospects. These factors collectively influence its adoption rate, revenue potential, and long-term sustainability.

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Market Overview and Demand Drivers

Clinical Need and Market Penetration

Cangrelor addresses a critical niche in acute cardiovascular management—providing fast, reversible platelet inhibition during PCI procedures. Its rapid onset (within seconds) and short half-life (3-6 minutes) make it particularly appealing for patients at high bleeding risk or those who require rapid drug effect termination, such as patients transitioning to oral P2Y12 inhibitors.

Despite its therapeutic advantages, cangrelor remains underutilized, primarily due to competition from established oral P2Y12 inhibitors like clopidogrel, prasugrel, and ticagrelor. These agents, with proven efficacy and cost advantages, dominate the market, relegating cangrelor to specific clinical scenarios and limited hospital settings.

Key Demand Influencers

• Clinical guidelines and physician preferences: Adoption hinges largely on cardiologists' confidence in evidence-based protocols and familiarity with the drug. While cangrelor's FDA approval was based on trials demonstrating non-inferiority in ischemic outcomes, some practitioners favor oral agents due to convenience and cost.

• Cesarean delivery of concomitant therapies: The ability of cangrelor to act as a seamless bridge during PCI or in patients with intolerance to oral agents influences its demand.

• Hospital adoption rate: As an intravenous agent, cangrelor’s utilization is concentrated within hospital settings, influencing overall sales potential.

Regulatory and Reimbursement Environment

The absence of widespread adoption is compounded by limited insurance coverage and reimbursement challenges, which restrict access and inhibit acute care centers from integrating cangrelor into routine practice. Moreover, the relatively high cost of the drug compared to oral alternatives diminishes its attractiveness.

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Competitive Landscape

Major Competitors

• Oral P2Y12 inhibitors: Clopidogrel, prasugrel, and ticagrelor dominate due to established safety profiles, extensive clinical data, and cost-effectiveness.

• Other Intravenous Agents: Glycoprotein IIb/IIIa inhibitors, such as abciximab, eptifibatide, and tirofiban, serve similar roles but with different mechanisms and bleeding profiles.

Market Challenges

The limited incremental benefit of cangrelor over oral agents in large-scale outcome trials, such as the CHAMPION program, has hampered broad adoption. The CHAMPION PCI trial (2013) demonstrated non-inferior safety compared to oral agents but failed to show superiority, which diminishes its market appeal [2].

Moreover, the rising use of oral P2Y12 inhibitors with rapid onset (e.g., ticagrelor) and improved safety profiles further constrain cangrelor’s niche.

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Regulatory Landscape and Market Expansion Opportunities

Global Approvals and Off-Label Use

Beyond the U.S., cangrelor has received approval in several countries in Europe, the Middle East, and Asia, often with less restrictive indications. These markets exhibit growth potential, especially where infusion-based therapies are standard for PCI.

Label Expansion and New Indications

Novartis has envisaged potential expansion into other acute settings—such as stroke or peripheral artery disease—though clinical validation is pending. Regulatory approvals for new indications could substantially alter its market dynamics.

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Financial Trajectory and Revenue Forecast

Historical Revenue Performance

Initial sales post-approval were modest, constrained by limited adoption and reimbursement hurdles. For example, in 2019, cangrelor generated approximately $34 million globally, with the majority from U.S. hospital sales [3].

Future Revenue Estimates

Considering the current market position and anticipated growth drivers, revenue projections are cautiously optimistic. Factors impacting these include:

• Increased hospital adoption driven by evolving clinical guidelines emphasizing rapid platelet inhibition techniques.
• Potential expansion into new markets, especially Asia and Europe, where infusion therapy protocols are prevalent.
• Line extensions or combination therapies, possibly pairing cangrelor with other antithrombotic agents, could revitalize interest.

An industry analysis suggests that, without substantial market penetration or clinical breakthrough, cangrelor’s revenue may remain within the $50-$100 million range annually over the next five years. However, targeted efforts to bolster clinical awareness and reimbursement support could accelerate growth toward $150 million or more.

Pricing Strategies and Cost Considerations

The per-dose pricing of cangrelor significantly influences its feasibility. Currently, cost per administration exceeds $1,000, which poses constraints, especially within cost-sensitive healthcare ecosystems. Negotiations with payers and institutional formularies are vital for expanding adoption.

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Strategic Outlook and Market Trends

Emerging Trends

• Advances in PCI and antithrombotic therapy: Adoption of newer, more potent oral agents with rapid onsets might limit reliance on intravenous alternatives, impacting cangrelor's growth.
• Personalized medicine approaches: Genetic testing for drug responsiveness and bleeding risk could refine patient selection, improving utilization in specific cohorts.
• Technological innovations: Improved infusion protocols and integration into catheterization lab workflows could facilitate higher usage.

Potential Growth Catalysts

• Regulatory approvals for new indications—pending ongoing clinical trials.
• Hospital protocols favoring intravenous agents due to safety or efficacy benefits.
• Market share gains through education emphasizing cangrelor's unique pharmacodynamics.

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Key Takeaways

• Cangrelor remains a niche player in the acute coronary syndrome therapeutic landscape, constrained by existing competition from oral P2Y12 inhibitors and limited clinical adoption.
• Market expansion hinges on increased hospital utilization, broader international approval, and potential label extensions.
• Financial prospects appear modest, with revenues likely stabilizing around current levels unless significant strategic shifts occur.
• Cost and reimbursement barriers present notable challenges; negotiations and value-based pricing are critical.
• The future of cangrelor depends on clinical trial outcomes, regulatory support, and evolving interventional cardiology practices.

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FAQs

1. What are the primary advantages of cangrelor over oral P2Y12 inhibitors?
Cangrelor offers rapid onset and offset, making it ideal for PCI procedures requiring immediate platelet inhibition and quick reversal if needed, especially in patients with gastrointestinal absorption issues or high bleeding risk.

2. Why has cangrelor not achieved widespread adoption since its approval?
Limited clinical superiority over oral agents, higher costs, reimbursement hurdles, and clinician familiarity with existing therapies have restricted its clinical uptake.

3. Are there plans to expand cangrelor’s indications?
Novartis continues to explore potential new indications, which depend on ongoing clinical trials. Regulatory approval for additional uses could enhance its market prospects.

4. How does the competitive landscape affect cangrelor’s sales?
Strong market presence of oral P2Y12 inhibitors and existing intravenous alternatives restrict its use to specific settings, limiting growth potential.

5. What strategies could improve cangrelor’s market performance?
Enhanced clinical education, reimbursement negotiations, international approvals, and evidence demonstrating superior outcomes could bolster utilization.

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References

[1] FDA Drug Label for Kengreal (cangrelor). 2015.
[2] Bhatt, D. L., et al. (2013). "Cangrelor Versus Clopidogrel in Patients Undergoing PCI." New England Journal of Medicine, 368(14), 1303–1313.
[3] Novartis Annual Report 2019.