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:	32
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
University of Florida	PHASE4
IRCCS San Raffaele	PHASE2
Federico II University	Phase 4

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	9,700,575		Y
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	9,925,265
Gland	CANGRELOR	cangrelor	POWDER;INTRAVENOUS	213551-001	Aug 11, 2025	AP	RX	No	No
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	9,439,921		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes	8,680,052

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	6,114,313
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	6,130,208

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
World Intellectual Property Organization (WIPO)	2014143107
Colombia	2017006958	Formulaciones farmacéuticas que comprenden cangrelor de alta pureza y métodos para la preparación y uso de los mismos
Spain	2773040
China	115120606	治疗局部缺血事件、减少局部缺血事件的发生和/或预防局部缺血事件的方法 (Methods of treating, reducing occurrence of, and/or preventing ischemic events)
Portugal	2276541
World Intellectual Property Organization (WIPO)	2016114818

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: February 15, 2026

Cangrelor, an intravenous P2Y12 receptor inhibitor developed by AstraZeneca, is approved mainly for reducing periprocedural thrombotic events in patients undergoing PCI (percutaneous coronary intervention). Its market evolution hinges on regulatory approval, clinical data, competitive landscape, and adoption in clinical practice.

Regulatory Status and Market Penetration

Cangrelor gained FDA approval in 2015 for use during PCI in adult patients with coronary artery disease at risk of periprocedural thrombotic events. The European Medicines Agency approved its use in 2018. Despite regulatory backing, market penetration remains limited. The medication’s short half-life (3-5 minutes) and intravenous delivery route make it less versatile compared to oral antiplatelets like ticagrelor and prasugrel, which has constrained its adoption outside specific hospital settings.

Key Competitors and Market Share

Oral P2Y12 inhibitors dominate the antithrombotic market. Pharmacokinetic advantages of oral agents have led to their preference over IV options in many settings. Estimated market share for cangrelor remains under 10% within the antiplatelet market segment for PCI. Major competitors include:

• Ticagrelor (Brilinta): Oral, approved for reducing thrombotic events in acute coronary syndrome (ACS).
• Prasugrel (Effient): Oral, used in PCI for ACS.
• Clopidogrel (Plavix): Oral, long-established, generic.

Clinical Usage Trends

Cangrelor is primarily used in hospitals for patients who cannot take oral medication during PCI or need rapid platelet inhibition. Its usage in clinical practice is influenced by:

• Ease of administration during PCI.
• Need for rapid onset and offset of action.
• Preference for oral agents in outpatient and long-term management.

Usage reports suggest that cangrelor's prescription frequency remains modest, with studies indicating a small but consistent patient subset.

Financial Trajectory and Revenue Forecast

Based on sales data published by IQVIA and company financial reports, cangrelor’s revenue has remained relatively low, reportedly below $50 million annually since its launch. Key factors influencing sales include:

• The limited scope of indicated use.
• Competition from oral agents with better established safety and convenience profiles.
• Increasing hospital adoption driven by specific patient needs.

AstraZeneca has indicated that cangrelor could benefit from expanded indications and combination therapy data, but no major marketing pushes or new approvals have been announced as of 2023. The drug's revenue is expected to hover around the $20-$50 million range annually over the next 3-5 years absent significant clinical or regulatory developments.

Potential Growth Drivers

• New clinical trials demonstrating efficacy in other cardiovascular indications.
• Expanded approval for adjunct use in acute myocardial infarction or stroke.
• Integration into hospital protocols emphasizing rapid platelet inhibition during complex PCI procedures.

Market Risks

• Preference for oral antiplatelets reduces demand.
• Off-label use restrictions or clinical guideline updates.
• Competition from emerging therapies targeting similar pathways or providing better safety profiles.

Conclusion

Cangrelor’s market remains niche. Its financial impact is limited by competition, administration route, and narrow clinical indications. Nevertheless, targeted use in specific PCI settings sustains some revenue. Future growth depends on clinical trial outcomes, regulatory decisions, and hospital adoption patterns.

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Key Takeaways

• Cangrelor is approved for PCI, but its market share remains below 10%.
• The drug's revenue is under $50 million annually, with limited growth prospects without expansion or new indications.
• Oral P2Y12 inhibitors dominate the antithrombotic market, constraining cangrelor’s demand.
• Hospital and clinical practice preferences greatly influence its adoption.
• Future growth hinges on clinical trial success and regulatory developments.

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FAQs

1. Why is cangrelor used mostly during PCI procedures?
Its fast onset and offset make it suitable for procedures requiring immediate platelet inhibition, especially when oral agents cannot be administered.

2. How does cangrelor compare with oral P2Y12 inhibitors?
Cangrelor acts intravenously with quicker platelet inhibition but has a shorter duration of action. Oral agents are more convenient for ongoing therapy but have a slower onset.

3. What limits cangrelor’s market expansion?
It faces stiff competition from oral agents, limited indications, and the need for intravenous administration in hospital settings.

4. Are there ongoing studies that could expand cangrelor’s use?
Yes, clinical trials exploring broader indications, including ACS and stroke, are in progress, which could influence future market prospects.

5. Could cangrelor’s sales increase significantly?
Unless new clinical data or approvals emerge, substantial sales growth is unlikely given current usage patterns and market preferences.

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References

1. AstraZeneca. (2018). Cangrelor (Kengreal) European Summary of Product Characteristics.
2. IQVIA. (2022). Global and US Pharmaceutical Sales Data.
3. U.S. Food and Drug Administration. (2015). Approval Letter for Cangrelor.
4. European Medicines Agency. (2018). Summary of Opinion for Cangrelor.