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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KENGREAL

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
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	9,700,575		Y

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
Iceland	5331
Canada	2844931	ENTRETIEN D'INHIBITION DE PLAQUETTES PENDANT THERAPIE ANTIPLAQUETTAIRE (MAINTENANCE OF PLATELET INHIBITION DURING ANTIPLATELET THERAPY)
Morocco	41326	FORMULATIONS PHARMACEUTIQUES COMPRENANT DU CANGRELOR DE HAUTE PURETÉ ET LEURS PROCÉDÉS DE PRÉPARATION ET D'UTILISATION
Portugal	2276541
Japan	6840197
Poland	2498731

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

KENGREAL (Cangrelor): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

KENGREAL (Cangrelor), an intravenous antiplatelet agent developed for rapid platelet inhibition in percutaneous coronary intervention (PCI), presents unique market and investment considerations. Initially approved by the FDA in 2015 for use during PCI in patients unable to tolerate oral antiplatelet therapy, its commercial trajectory has faced challenges owing to competition, limited approved indications, and evolving clinical guidelines. This report analyzes its market dynamics, potential growth pathways, and financial outlook to inform investment strategies.

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What Is KENGREAL (Cangrelor)?

Attribute	Details
Approval Date	December 2015 (FDA)
Manufacturer	The Medicines Company (acquired by Novartis in 2020)
Indication	IV antiplatelet agent for patients undergoing PCI who are not treated with abciximab and unable to tolerate oral P2Y12 inhibitors
Mechanism of Action	Reversible inhibition of platelet aggregation via P2Y12 receptor blockade
Administration	Continuous IV infusion during PCI, rapid onset and offset of action

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Market Dynamics

1. Current Market Landscape

Parameter	Details
CAG and P2Y12 Inhibitor Competition	Primarily competes with oral agents like clopidogrel, prasugrel, ticagrelor
Alternative Agents	IV agents (e.g., glycoprotein IIb/IIIa inhibitors, eptifibatide)
Market Size (Global PCI procedures)	Approximately 1.7 million annually in the US (2022) and growing
Market Share	Limited, attributable to competition and narrow indications

2. Key Market Challenges

Challenge	Impact
Limited therapeutic indication restricts market penetration	Focus on acute settings, narrow patient subset
Competition from oral P2Y12 inhibitors with convenience	Oral agents like ticagrelor preferred for ease of administration
Pricing pressures and reimbursement hurdles	Reduced margins and adoption barriers
Clinical guideline adoption	Lag in preparation for broad adoption outside immediate PCI context

3. Potential Market Expansion Factors

• Expanding Indications: Combination with other antithrombotic therapies or acute coronary syndrome (ACS) protocols.
• Oncology and Thrombosis: Emerging off-label research.
• Global Markets: Expanding beyond US, especially in Europe and Asia where clinical practices differ.
• Innovative Delivery: Potential new formulations for broader or more convenient use.

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Financial Trajectory and Investment Considerations

1. Revenue and Sales Trends

Year	Estimated US Sales (USD)	Growth/Decline	Notes
2016	$105 million	—	Post-approval uptake
2017	$95 million	Decline	Due to initial hesitancy
2018	$80 million	Decline	Market saturation, competition
2019	$75 million	Slight decline	Reimbursement pressures
2020	$70 million	Decline	Acquisition by Novartis late in year
2021	$65 million	Slight decline	Ongoing market challenges

Note: Figures are estimates based on available data.

2. Financial Outlook

• 2022–2025 projections indicate stabilization or slight decline in US sales due to limited indications unless new uses are approved.
• Emerging markets and hospital protocols may provide upside.

3. Investment Risks

Risk Factors	Implications
Pipeline and Label Expansion	Delays or failure limit growth opportunities
Pricing and Reimbursement	Price erosion reduces profitability
Competitive Advancements	New IV or oral agents may replace KENGREAL
Regulatory Approvals	Challenges in expanding indications or formulations

4. Strategic Opportunities

Opportunity	Description
New Indications	Stroke, myocardial ischemia, or other thrombotic events
Combination Therapies	Synergy with other antithrombotic agents
Formulation innovations	Less invasive delivery routes or sustained-release forms
Global Market Penetration	Tailored strategies for emerging markets

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Comparison with Key Competitors

Agent	Type	Indications	Administration	Market Position
Cangrelor (KENGREAL)	IV P2Y12 inhibitor	PCI, No oral P2Y12 tolerance	Continuous IV infusion	Niche, hospital setting
Ticagrelor (Brilinta)	Oral P2Y12 inhibitor	ACS, PCI	Oral	Primary competitor, convenience
Prasugrel (Effient)	Oral P2Y12 inhibitor	ACS, PCI	Oral	Similar market but limited outside PCI
Glycoprotein IIb/IIIa inhibitors	IV	Acute coronary syndromes	IV bolus/infusion	Alternative for specific cases

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Regulatory and Policy Environment

1. FDA Post-Marketing Requirements

• Novartis committed to additional clinical trials for expanded indications.
• CDC and hospital protocols influence usage patterns, emphasizing rapid administration in PCI.

2. Reimbursement Policies

Payer Type	Coverage	Challenges
Medicare/Medicaid	Reimbursement largely aligned	Need for clear value demonstration
Private Insurers	Varies; favor oral agents	Limited coverage outside PCI

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Future Prospects and Forecasting

Year	Estimated US Revenue (USD)	Global Revenue Potential	Key Growth Drivers
2023	$60 million	$150 million	Clinical guideline adoption, expanded indication trials
2024	$70 million	$180 million	New formulation approvals, international expansion
2025	$80 million	$200 million	Integration into broader acute coronary protocols

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Key Takeaways

• KENGREAL's niche position in the hospital setting limits its market growth unless new indications or formulations emerge.
• Competition from oral P2Y12 inhibitors is a primary obstacle; thus, differentiation relies on rapid onset/offset benefits.
• Potential expansion via novel clinical trials targeting broader thrombotic events could unlock growth.
• Cost management, reimbursement strategy, and clinical protocol integration are critical for sustained revenue.
• Acquiring and leveraging new delivery methods or combination therapies could alter the financial trajectory favorably.

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FAQs

Q1: What are the main challenges facing KENGREAL's market expansion?
Limited indications, competition from oral agents, reimbursement issues, and slow adoption of new clinical guidelines are primary challenges.

Q2: Are there ongoing clinical trials that could expand KENGREAL's uses?
Yes, several trials are evaluating its use in stroke, acute myocardial infarction, and thrombotic complications outside PCI (clinical trial registries: ClinicalTrials.gov).

Q3: How does KENGREAL compare price-wise to competing agents?
Pricing remains comparable to other IV antiplatelet agents but is generally limited by hospital procurement budgets and reimbursement policies.

Q4: What opportunities exist for global market growth?
Emerging markets with different clinical practices, expanding indications, and new formulations offer growth potential.

Q5: Could new formulations improve market adoption?
Yes, sustained-release formulations or less invasive delivery methods may facilitate broader use by reducing administration complexity.

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References

[1] The Medicines Company. (2015). FDA approval of KENGREAL (Cangrelor).
[2] Novartis. (2020). Acquisition announcement of The Medicines Company.
[3] American College of Cardiology. (2022). PCI procedure statistics.
[4] IMS Health. (2022). Global cardiovascular drug market analysis.
[5] ClinicalTrials.gov. (Accessed 2023). Ongoing trials involving cangrelor.

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