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 one branded drug marketed by Chiesi and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for cangrelor. One supplier is listed for this compound.

Summary for CANGRELOR

International Patents:	73
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	30
Patent Applications:	1,088
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CANGRELOR

Constraining patent/regulatory exclusivity:

9,439,921

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CANGRELOR

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

Sponsor	Phase
Federico II University	Phase 4
Mercy Health Ohio	Phase 3
Fondation Ophtalmologique Adolphe de Rothschild	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		RX	Yes	Yes	8,680,052
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	10,039,780
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,439,921		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,295,687		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,700,575		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,427,448
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,925,265

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/003773 Kengrexal, 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
Australia	2009246396	Maintenance of platelet inhibition during antiplatelet therapy
China	106102750	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 the incidence of, and/or preventing ischemic events)
World Intellectual Property Organization (WIPO)	2011060066
World Intellectual Property Organization (WIPO)	2016114818
Canada	2844931	ENTRETIEN D'INHIBITION DE PLAQUETTES PENDANT THERAPIE ANTIPLAQUETTAIRE (MAINTENANCE OF PLATELET INHIBITION DURING ANTIPLATELET THERAPY)
Russian Federation	2733409	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, ВКЛЮЧАЮЩИЕ КАНГРЕЛОР ВЫСОКОЙ ЧИСТОТЫ, И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (PHARMACEUTICAL COMPOSITIONS CONTAINING HIGH-PURITY CANGRELOR, AND METHODS FOR PRODUCTION AND USE THEREOF)
Japan	6247708

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

CANGRELOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cangrelor

Introduction to Cangrelor

Cangrelor is an intravenous, direct-acting, reversible P2Y12 platelet inhibitor used to reduce the risk of periprocedural thrombotic events in patients undergoing percutaneous coronary intervention (PCI), particularly in cases where oral P2Y12 inhibitors are not feasible or desirable[1][5].

Market Size and Growth Projections

The cangrelor market is anticipated to experience significant growth over the coming years. In 2023, the market size was projected to be approximately $2.02 billion USD, and it is expected to increase from $2.21 billion in 2024 to $4.6 billion by 2032. This growth is driven by a compound annual growth rate (CAGR) of about 9.58% during the forecast period of 2024-2032[1].

Market Drivers

Increasing Prevalence of Cardiovascular Diseases (CVDs)

The rising incidence of CVDs is a major driver for the cangrelor market. Cardiovascular diseases are the leading cause of death globally, and the need for effective antiplatelet therapies is increasing accordingly[1][4].

Advancements in PCI Procedures

Continuous advancements in PCI techniques, including the adoption of newer stents and catheters, enhance the effectiveness of these procedures. Cangrelor's role in reducing thrombotic complications during PCI makes it a critical component in modern interventional cardiology[1].

Growing Awareness of Antiplatelet Therapy

The medical community's increasing recognition of the importance of antiplatelet therapy in managing patients with coronary artery disease (CAD) is driving the demand for effective agents like cangrelor[1].

Market Trends

Adoption in Emergency and Acute Care Settings

There is a notable trend towards the increasing adoption of cangrelor in emergency and acute care settings, particularly during PCI procedures where rapid platelet inhibition is crucial[1].

Preference for Intravenous Antiplatelet Therapies

There is a growing preference for intravenous antiplatelet therapies in patients who are unable to take oral medications, such as those undergoing surgery or with conditions that affect absorption[1].

Integration with Other Antithrombotic Agents

The market is witnessing a trend towards the integration of cangrelor with other antithrombotic agents to optimize patient outcomes, reflecting a broader move towards personalized medicine in cardiovascular care[1].

Market Challenges

Competition from Oral Antiplatelet Agents

Despite its unique IV formulation, cangrelor faces competition from well-established oral P2Y12 inhibitors like clopidogrel, prasugrel, and ticagrelor. The convenience of oral administration and the cost-effectiveness of these alternatives may limit the widespread adoption of cangrelor[1].

High Cost of Treatment

The cost associated with cangrelor therapy can be a significant barrier, particularly in regions with limited healthcare budgets or restrictive reimbursement policies[1].

Financial Impact and Budget Analysis

Budget Impact in the UK

A budget impact analysis in the UK indicated that introducing cangrelor could lead to a modest cost increase, but it also predicted cost savings and a reduction in hospital days. Over five years, cangrelor was estimated to lead to a cost saving of £1,531,266, with a reduction in hospital days and clinical events[2].

Financial Impact in Spain

In Spain, a budget impact model showed that the financial effort needed to introduce cangrelor barely exceeded one million € over three years. The analysis considered the cost difference between scenarios with and without cangrelor for treating CAD patients undergoing PCI[5].

Competitive Landscape

The cangrelor market is highly competitive, with key players such as Johnson & Johnson, Bayer AG, F. Hoffmann-La Roche Ltd, Eli Lilly and Company, The Medicines Company, Merck & Co., Inc., Boehringer Ingelheim, and others. These companies are engaged in strategic initiatives like product development, partnerships, and market expansion to strengthen their positions in the antiplatelet therapy market[1].

Segmental Breakdown

The cangrelor market is segmented based on dosage form, administration route, indication, end user, distribution channel, and region. The primary dosage form is intravenous, with administration typically occurring in hospital settings during PCI. Key end users include hospitals, ambulatory surgical centers, and specialty clinics, with distribution channels including hospital pharmacies, retail pharmacies, and online pharmacies[1].

Geographical Analysis

The market is divided into regions such as North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America holds the largest market share due to advanced healthcare infrastructure and high awareness of antiplatelet therapies[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry, including the market for cangrelor. While it has disrupted supply chains and affected production, the increased focus on healthcare has also driven demand for critical medications like cangrelor[4].

Key Takeaways

• The cangrelor market is expected to grow significantly, driven by the increasing prevalence of CVDs and advancements in PCI procedures.
• The market faces competition from oral antiplatelet agents and is challenged by high treatment costs.
• Financial analyses in various regions indicate potential cost savings and reduced hospital days with the use of cangrelor.
• The competitive landscape is dominated by major pharmaceutical companies engaging in strategic initiatives.
• Geographical analysis shows North America as the leading market due to advanced healthcare infrastructure.

FAQs

What is Cangrelor used for?

Cangrelor is used to reduce the risk of periprocedural thrombotic events in patients undergoing percutaneous coronary intervention (PCI), especially when oral P2Y12 inhibitors are not feasible or desirable[1].

What are the key drivers of the Cangrelor market?

The key drivers include the increasing prevalence of cardiovascular diseases, advancements in PCI procedures, and growing awareness of antiplatelet therapy[1].

How does Cangrelor compare to oral antiplatelet agents?

Cangrelor faces competition from oral P2Y12 inhibitors due to their convenience and cost-effectiveness, but it offers rapid onset and offset of action, making it crucial in emergency and acute care settings[1].

What is the financial impact of introducing Cangrelor in healthcare settings?

Introducing Cangrelor can lead to modest cost increases but also potential cost savings and reductions in hospital days and clinical events, as seen in budget impact analyses in the UK and Spain[2][5].

Who are the major players in the Cangrelor market?

Major players include Johnson & Johnson, Bayer AG, F. Hoffmann-La Roche Ltd, Eli Lilly and Company, and others, who are engaged in strategic initiatives to strengthen their market positions[1].