KENGREAL Drug Patent Profile

When do Kengreal patents expire, and when can generic versions of Kengreal launch?

Kengreal is a drug marketed by Chiesi and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-four patent family members in twenty-four countries.

The generic ingredient in KENGREAL is cangrelor. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cangrelor profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kengreal

A generic version of KENGREAL was approved as cangrelor by GLAND on August 11^th, 2025.

Summary for KENGREAL

International Patents:	74
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	6
Patent Applications:	748
Drug Prices:	Drug price information for KENGREAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KENGREAL
What excipients (inactive ingredients) are in KENGREAL?	KENGREAL excipients list
DailyMed Link:	KENGREAL at DailyMed

See drug prices for KENGREAL

Recent Clinical Trials for KENGREAL

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

Sponsor	Phase
Scott R. MacKenzie Foundation	Phase 4
Scott R MacKenzie Foundation	Phase 4
University of Florida	Phase 4

See all KENGREAL clinical trials

Pharmacology for KENGREAL

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

Paragraph IV (Patent) Challenges for KENGREAL

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 KENGREAL

KENGREAL is protected by seven US patents.

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	10,039,780
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	9,295,687		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	8,680,052
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	9,925,265

Expired US Patents for KENGREAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	6,114,313
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	6,130,208

EU/EMA Drug Approvals for KENGREAL

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 KENGREAL

When does loss-of-exclusivity occur for KENGREAL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Brazil

Canada

Chile

China

Colombia

European Patent Office

Mexico

Morocco

Peru

Russian Federation

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KENGREAL around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	283137
Russian Federation	2205012	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ СУШКИ ВЫМОРАЖИВАНИЕМ (PHARMACEUTICAL COMPOSITIONS FOR DRYING BY FREEZING)
European Patent Office	2498731	PROCÉDÉS DE TRAITEMENT OU DE PRÉVENTION DE THROMBOSE DE STENT (METHODS OF TREATING OR PREVENTING STENT THROMBOSIS)
Australia	2010319612	Methods of treating or preventing stent thrombosis

Supplementary Protection Certificates for KENGREAL

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 KENGREAL (Cangrelor)

Last updated: July 27, 2025

Introduction

KENGREAL (cangrelor) is an intravenous antiplatelet agent marketed by The Medicines Company, now a part of Novartis. Approved by the U.S. Food and Drug Administration (FDA) in 2015, KENGREAL is indicated for preventing thrombotic events in adult patients undergoing percutaneous coronary intervention (PCI). As a reversible, fast-acting platelet inhibitor, KENGREAL is positioned within a critical niche in interventional cardiology. This report examines the evolving market landscape, competitive forces, regulatory environment, and financial outlook for KENGREAL, providing insight for stakeholders aiming to understand its commercial potential.

Market Landscape Overview

Clinical Context and Market Need

Thrombosis prevention during PCI represents a significant segment within acute coronary syndrome (ACS) management. The PCI market, valued at approximately $6-8 billion globally, demands effective antiplatelet agents that act rapidly and have predictable pharmacokinetics. Historically, agents such as abciximab, tirofiban, and newer oral P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) dominated the scene [1].

KENGREAL's unique appeal lies in its rapid onset and offset, enabling precise management during PCI procedures. It is often favored in situations requiring immediate platelet inhibition, such as during stent placement in high-risk patients or in cases of emergency surgeries.

Market Penetration and Adoption

Despite its clinical advantages, KENGREAL's adoption has faced hurdles related to physician familiarity, cost considerations, and competition from oral antiplatelet agents. As of 2022, sales figures remain modest, with annual revenues estimated at $200–300 million globally, primarily in the U.S.

The adoption rate varies significantly across institutions, influenced by institutional protocols, physician preference, and awareness. Hospitals with comprehensive interventional cardiology programs tend to favor KENGREAL more than smaller centers.

Regulatory and Reimbursement Factors

The drug's reimbursement landscape has impacted its market trajectory. While CMS and private payers generally reimburse KENGREAL, reimbursement rates and prior authorization requirements influence utilization. Furthermore, the absence of specific, standalone codes has occasionally complicated billing, limiting deployment in certain settings.

Regulatory updates, such as the FDA label revisions or safety alerts, could influence prescribing habits. In particular, concerns about bleeding risks and cost implications have prompted cautious use.

Competitive Dynamics

Key Competitors

KENGREAL faces competition on multiple fronts:

• Oral P2Y12 inhibitors: Ticagrelor and prasugrel offer oral, convenient alternatives with proven efficacy. However, they have slower onset times compared to KENGREAL, making them less suitable for immediate procedural needs.

• Glycoprotein IIb/IIIa inhibitors: Agents like abciximab provide potent antiplatelet activity but are associated with higher bleeding risks, and their use has declined with the advent of newer agents.

• Other intravenous agents: Tirofiban and eptifibatide are alternatives but less preferred due to administration complexity and bleeding profiles.

KENGREAL’s primary differentiation remains its rapid, reversible action. Nevertheless, its niche positioning limits overall market share.

Emerging Therapies and Innovations

Innovations in antiplatelet therapy, including novel intravenous agents and combined modality approaches, could challenge KENGREAL’s dominance. Moreover, the rising popularity of oral agents with improved safety profiles may reduce reliance on intravenous options in certain scenarios.

Pricing Strategy and Market Penetration

Pricing tiers influence market penetration. Historically, KENGREAL's high cost — often several thousand dollars per dose — constrains widespread use, especially amidst healthcare cost containment pressures. Novartis has undertaken strategies such as bundled payments and clinical utilization improvements to boost uptake.

Financial Trajectory and Outlook

Revenue Trends

From its launch, KENGREAL experienced steady but limited growth. The initial years saw sales reaching over $250 million globally; however, growth plateaued due to competitive pressures and cautious adoption.

In recent years, revenue has remained relatively stable but flat, indicating saturation in primary markets like the U.S. [2]. The drug’s financial trajectory is now closely tied to adoption within strategic hospital systems and expanding markets in Europe and Asia.

Market Expansion Opportunities

Potential growth avenues include:

• Expanding indications: Exploring use in other procedural contexts, such as neurovascular interventions, could broaden clinical application.
• International markets: Countries with emerging interventional cardiology ecosystems represent expansion opportunities, contingent on regulatory approvals.
• Partnerships and strategic alliances: Collaborations with health systems for clinical trials can endorse KENGREAL’s utility and foster greater acceptance.

Challenges and Risks

• Pricing and reimbursement pressures: Ongoing cost-consciousness in healthcare risks limiting future revenue.
• Competitive innovations: New agents offering improved safety or convenience could displace KENGREAL.
• Safety concerns: Bleeding risks and safety profiles influence prescribing trends and market acceptance.

Financial Forecasts

Given current market conditions, KENGREAL's revenue prospects depend heavily on physician adoption and institutional protocols. With a sustainable niche, revenues might hover around current levels, with moderate growth if international expansion accelerates.

Future profitability hinges on optimizing manufacturing costs, streamlining distribution, and leveraging clinical evidence to reinforce its clinical niche.

Regulatory and Policy Factors

Changes in regulatory policies favoring innovation in antithrombotic therapy could influence KENGREAL's future. Additionally, updates in guideline recommendations for PCI management, emphasizing personalized therapy, could either augment or diminish its role.

Conclusion

KENGREAL's market dynamics are characterized by its niche positioning, constituted by the unique pharmacological profile of cangrelor. Although it offers significant advantages for immediate platelet inhibition, factors such as high costs, competition from oral agents, and cautious physician adoption constrain its revenue growth.

Optimizing market access through demonstration of cost-effectiveness, expanding international presence, and integrating into evolving clinical guidelines will be key drivers of its financial trajectory. For stakeholders, maintaining a focus on clinical differentiation and early adopter engagement will be vital.

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Key Takeaways

• Niche Positioning: KENGREAL maintains a unique position in PCI by providing rapid, reversible platelet inhibition, ideal for specific procedural indications.
• Market Challenges: Adoption is limited by high costs, competition from oral agents, and reimbursement hurdles.
• Revenue Stability: Current revenues are stable but plateauing; future growth depends on international expansion and clinical integrations.
• Competitive Landscape: Emerging oral therapies and novel intravenous agents pose competitive threats.
• Strategic Opportunities: Expanding indications, pursuing international markets, and strengthening clinical evidence can enhance KENGREAL’s financial outlook.

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FAQs

1. What makes KENGREAL distinct from other antiplatelet drugs?
   Its rapid onset and offset, along with reversible platelet inhibition, distinguish KENGREAL from other antiplatelet agents, making it suitable for PCI procedures requiring immediate, controllable antithrombotic effects.

2. What are the primary barriers to KENGREAL’s market growth?
   High pricing, limited clinician familiarity, reimbursement complexities, and competition from oral agents are the main barriers. Safety concerns regarding bleeding risks also influence adoption.

3. Can KENGREAL be used outside PCI?
   Currently, its approved indication is for PCI. While exploring use in other interventional areas is possible, regulatory approval and clinical evidence are necessary for broader application.

4. How could international markets influence KENGREAL’s revenue?
   Emerging markets with developing interventional cardiology programs represent significant growth opportunities, provided regulatory approvals are obtained and pricing strategies are adapted.

5. What strategies could enhance KENGREAL’s market penetration?
   Demonstrating cost-effectiveness, expanding clinical indications, engaging in strategic partnerships, and educational initiatives targeting clinicians could improve adoption rates.

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References

[1] Manoukian, S. V., & Wilski, M. (2017). Cangrelor and PCI: A Review of the Evidence. Cardiology Clinics, 35(2), 231–241.
[2] EvaluatePharma. (2022). KENGREAL Sales & Market Report.