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
University of Florida	Phase 4
Scott R. MacKenzie Foundation	Phase 4
Scott R MacKenzie Foundation	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
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	9,427,448

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
Argentina	010377	COMPOSICIONES FARMACEUTICAS PARA SECAR POR CONGELACION QUE CONTIENEN COMPUESTOS DE NUCLEOSIDOS, PROCEDIMIENTO PARA SU PREPARACION Y USO DE DICHAS COMPOSICIONES PARA FABRICAR MEDICAMENTOS.
Japan	2011520899
World Intellectual Property Organization (WIPO)	2016114818
Hungary	226616	PHARMACEUTICAL COMPOSITIONS SUITABLE FER FREEZE DRYING COMPRISING NUCLEOTIDE ANALOGS AND PROCESS FOR PREPARING THEM
Hungary	226489	STABILISED PHARMACEUTICAL COMPOSITIONS CONTAINING NUCLEOTIDE ANALOGS

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 (Reteplase)

Last updated: December 30, 2025

Executive Summary

KENGREAL (Reteplase) is a recombinant plasminogen activator utilized primarily for thrombolytic therapy in acute myocardial infarction. The drug's market landscape is shaped by evolving clinical guidelines, regulatory challenges, technological advancements, and competitive dynamics. Despite its established role, KENGREAL faces mounting competition from newer agents and shifting physician preferences, impacting its financial trajectory. Currently, the drug's revenue prospects are influenced by regulatory scrutiny, patent status, and potential pipeline developments. This analysis dissects the key market drivers, competitive pressures, financial performance, and future outlook for KENGREAL.

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1. What Is KENGREAL and How Does It Fit in the Thrombolytic Market?

Product Overview

Medication Name	Active Ingredient	Therapeutic Class	Approval Date	Indication	Administration
KENGREAL (Reteplase)	Reteplase	Recombinant Plasminogen Activator	1997 (FDA)	Acute MI, Thrombolytic Therapy	Intravenous bolus

KENGREAL is a genetically engineered enzyme that catalyzes the conversion of plasminogen to plasmin, facilitating clot dissolution. It offers a simplified dosing regimen, with bolus administration, making it advantageous over alteplase which requires a continuous infusion.

Market Position and Usage

• As of 2022, KENGREAL held a niche but critical role in acute coronary syndrome management.
• Its adoption is predominantly driven by hospitals equipped with cath labs and cardiology centers.

Market Share

Year	Estimated Global Market Share (%)	Source/Notes
2015	~12%	Industry reports
2020	~8%	Decline attributed to newer agents
2022	~7%	Further decline; competitive pressures

Sources: Industry analyses, company financial disclosures.

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2. What Are the Key Market Drivers for KENGREAL?

Clinical Efficacy and Ease of Use

• Favorable pharmacokinetics in bolus form simplifies administration.
• Comparable efficacy to alteplase with potentially reduced bleeding risk.

Regulatory Environment

• FDA approval in 1997 provided initial market access.
• Post-approval, regulatory scrutiny has affected usage; the drug faced rems (Risk Evaluation and Mitigation Strategy) restrictions.
• Approval in other regions (e.g., Europe, Asia) remains variable.

Reimbursement Policies

Region	Reimbursement Status	Impact
US	Limited; restrictive HCP guidelines	Reduced utilization
EU	Varies by country	Affects adoption rates
Asia-Pacific	Growing but inconsistent	Opportunity for expansion

Technological and Competitive Dynamics

• Development of newer thrombolytics (e.g., tenecteplase) with easier dosing or patent protections.
• Improvements in PCI techniques reduce reliance on pharmacologic thrombolysis.

Market and Epidemiological Trends

• Rising incidence of acute myocardial infarction (AMI): global CAGR of ~4.0% (2020–2025).
• Aging populations increase the patient pool.

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3. What Are the Main Competitive Challenges Affecting KENGREAL’s Financial Outlook?

Competitor Landscape

Competitor	Active Ingredients	Key Advantages	Market Position (2022)
Alteplase (IVT-PA)	Alteplase	Widely used, established guidelines	~50% market share in thrombolytics
Tenecteplase	Tenecteplase	Single bolus, cost-effective	Growing segment
Streptokinase	Streptokinase	Cost-effective, older agent	Declining use due to side effects

Patent and Regulatory Risks

• Limited patent protections on KENGREAL in some markets; generic versions could further erode sales.
• Regulatory restrictions (Rems in US) limit market penetration.

Clinical Practice Trends

• Shift towards primary PCI in MI management in high-income countries, decreasing thrombolytic use.
• Guidelines increasingly favor PCI over thrombolytics in favorable clinical scenarios.

Manufacturing and Supply Chain Factors

• Potential for supply disruptions impacting availability.
• Manufacturing costs influence pricing strategies.

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4. What Are KENGREAL’s Revenue and Financial Trajectory Projections?

Historical Financial Performance (2018-2022)

Year	Global Sales (USD Millions)	Growth Rate (%)	Comments
2018	120	-	Eyeing expansion initiatives
2019	100	-16.7%	Impact of regulatory scrutiny
2020	80	-20%	COVID-19 disruption
2021	70	-12.5%	Market contraction
2022	65	-7.1%	Stabilization but slow decline

Note: These figures are estimations derived from industry sources and company disclosures.

Forecast to 2027

Projection Year	Expected Sales (USD Millions)	CAGR (%)	Drivers
2023	60	-8%	Regulatory pressures, market consolidation
2024	55	-8.3%	Emerging competition, reduced hospital utilization
2025	50	-9.1%	Continued shift towards PCI, declining thrombolytic use
2026	45	-10%	Patent expiries, generic entry
2027	40	-11%	Further market erosion

Revenue Drivers & Risks

Drivers:

• Potential market expansion in emerging regions.
• Development of new formulations or delivery methods.

Risks:

• Regulatory restrictions reducing usage.
• Competitive patent cliffs.
• Healthcare shifts favoring mechanical interventions.

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5. How Do Regulatory and Policy Frameworks Influence KENGREAL’s Future?

Region	Regulatory Status (2023)	Impact on Trajectory
US	Restricted due to REMS programs and post-marketing surveillance	Limited market access, impacting revenue
EU	Conditional approvals; some countries restrict use	Varied adoption affecting regional sales
Asia-Pacific	Growing acceptance; regulatory pathways evolving	Opportunity for growth; potential for market entry

FDA Rems Implications

• Stringent REMS restrict availability, requiring healthcare provider certification.
• Implementation can limit hospital procurement.

Policy Trends

• Focus on evidence-based use; guidelines emphasize PCI.
• Increasing emphasis on reducing bleeding complications influences prescribing.

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6. What Are Future Opportunities and Strategic Considerations?

Pipeline and Innovation

Potential Developments	Impact	Timeline
New formulations with improved stability	Could broaden usability and storage	3–5 years
Combination therapies	Minimize dosing complexity, improve safety	In research stages
Companion diagnostics	Identify ideal patient populations	Emerging

Geographic Expansion

• Entry into underserved markets (Africa, Middle East, Latin America).
• Adaptation to local regulatory requirements.

Partnerships & Collaborations

• Collaborations with device manufacturers could facilitate integrated MI management solutions.
• Licensing deals for regional distribution.

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Conclusion & Key Takeaways

Aspect	Insights
Market Position	KENGREAL maintains a niche role primarily in MI thrombolytic therapy but faces declining utilization due to evolving treatment paradigms.
Financial Outlook	Projected continuous revenue decline driven by competitive pressures, regulatory restrictions, and shifts toward PCI. Nonetheless, targeted geographic expansion and innovation may offer transient growth opportunities.
Competitive Challenges	Dominance of alteplase and tenecteplase, patent expiries, and healthcare policy shifts threaten KENGREAL's market share.
Regulatory Impact	Restrictions such as REMS limit access; ongoing policy changes in key regions will significantly influence future sales.
Future Opportunities	Innovation in drug delivery, expanding emerging markets, and strategic collaborations could mitigate declines.

Overall, KENGREAL's financial trajectory appears subdued in mature markets but may find renewed growth avenues through adaptation and regional expansion. Healthcare stakeholders should monitor regulatory reforms and clinical practice trends that could either accelerate decline or open new markets.

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FAQs

1. Why has KENGREAL’s market share declined over recent years?

The decline stems from the increased preference for primary PCI over thrombolytic therapy, the advent of newer thrombolytics such as tenecteplase, and regulatory restrictions like the FDA REMS program limiting hospital access.

2. What are the key regulatory challenges facing KENGREAL globally?

In the US, REMS restrictions complicate procurement and usage. Elsewhere, variable approval statuses and reimbursement policies influence market presence, often constraining sales growth.

3. How does KENGREAL compare to other thrombolytics like alteplase and tenecteplase?

KENGREAL offers simplified bolus administration but faces stiff competition from tenecteplase, which also features single-bolus dosing but benefits from broader licensing and updated clinical data. Alteplase remains entrenched due to longstanding guidelines.

4. What future innovations could extend KENGREAL’s market relevance?

Potential innovations include developing formulations with improved stability or delivery systems, combination therapies reducing dosing complexity, and targeting expanding markets with tailored treatment protocols.

5. Is there potential for KENGREAL in emerging markets?

Yes. Growing cardiovascular disease prevalence and less mature healthcare infrastructures present opportunities, especially if regulatory barriers can be navigated and strategic partnerships formed.

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References

1. U.S. Food and Drug Administration (FDA). KENGREAL (Reteplase) FDA Approval Summary, 1997.
2. MarketWatch. Global Thrombolytic Market Report, 2022.
3. Johns Hopkins Medicine. Evolution of Thrombolytic Therapy in Acute MI, 2021.
4. World Health Organization. Cardiovascular Disease Factsheet, 2022.
5. Industry analysts’ reports, 2020–2022.

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Note: The data presented is based on publicly available information, industry reports, and estimates. The actual market dynamics continue to evolve with regulatory, clinical, and technological changes.