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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-three patent family members in twenty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Kengreal

Kengreal was eligible for patent challenges on June 22, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2035. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KENGREAL

International Patents:	73
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	6
Patent Applications:	519
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

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

Constraining patent/regulatory exclusivity:

9,439,921

NDA:

204958

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 KENGREAL

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

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

This potential generic entry date is based on patent 9,439,921.

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

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	10,039,780
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	8,680,052
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,925,265
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	9,700,575		Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015		RX	Yes	Yes	9,439,921		Y

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/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 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
European Patent Office	3244900	FORMULATIONS PHARMACEUTIQUES COMPRENANT DU CANGRELOR DE HAUTE PURETÉ ET LEURS PROCÉDÉS DE PRÉPARATION ET D'UTILISATION (PHARMACEUTICAL FORMULATIONS COMPRISING HIGH PURITY CANGRELOR AND METHODS FOR PREPARING AND USING THE SAME)
Japan	2001509512
Australia	758857
New Zealand	336027	Pharmaceutical compositions for freeze drying comprising a nucleotide analogue, mannitol and a modifying additive which is sodium chloride or a polyol
Poland	334006
Turkey	9901412
Spain	2601524

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KENGREAL (Cangrelor)

Introduction to KENGREAL

KENGREAL, also known as cangrelor, is an intravenous, direct-acting, reversible P2Y12 platelet inhibitor. It is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor[2][4].

Market Assessment and Historical Sales

The global market assessment for KENGREAL includes historical sales data and forecasted sales estimates. According to DelveInsight's report, the historical global sales of KENGREAL have been analyzed, and sales estimations are provided for the forecasted period. This data is crucial for understanding the drug's market performance and potential future growth[1].

Clinical Efficacy and Safety

KENGREAL has demonstrated significant clinical efficacy in reducing periprocedural thrombotic events. The CHAMPION PHOENIX trial showed that KENGREAL provided a relative risk reduction in the composite outcome of major adverse cardiac events (MACE), including death, MI, ischemia-driven revascularization, and stent thrombosis, compared to clopidogrel. However, it also increased the risk of bleeding events, although without a statistically significant increase in severe bleeding or the need for transfusion[2][3].

Market Competition

KENGREAL operates in a competitive market with other P2Y12 inhibitors such as clopidogrel, prasugrel, and ticagrelor. The drug's unique profile as a parenteral agent with rapid onset and offset of action differentiates it from oral P2Y12 inhibitors. This differentiation is particularly beneficial in high-risk PCI cases where immediate platelet inhibition is necessary[2].

Patent Exclusivity and Market Exclusivity

Understanding the patent expiry timeline and market exclusivity details is crucial for planning developmental timelines and generic strategies. DelveInsight's report provides comprehensive information on these aspects, helping stakeholders navigate the intellectual property landscape surrounding KENGREAL[1].

Financial Impact and Cost-Consequence Analysis

Several studies have analyzed the financial impact of using KENGREAL in cardiac patients undergoing PCI. A cost-consequence analysis published in the American Journal of Cardiovascular Drugs estimated the impact on outcomes and total cost of care over three years. The analysis suggested that while the acquisition costs of KENGREAL are higher, potential savings from reduced periprocedural event rates and avoidance of delays in coronary artery bypass graft (CABG) surgery due to the offset of action of P2Y12 inhibitor pretreatment can be significant[4].

In Spain, a budget impact model calculated the cost difference between scenarios with and without cangrelor over three years. The results indicated a total budget impact of approximately €1,021,717, with the costs varying from €50,245 in the first year to €599,272 in the third year. The study concluded that the financial effort needed to introduce cangrelor is manageable and potentially beneficial in reducing overall healthcare costs[5].

SWOT Analysis

A SWOT analysis of KENGREAL highlights its strengths, such as rapid platelet inhibition and quick offset, which are particularly beneficial in high-risk PCI cases. However, it also identifies weaknesses, including the increased risk of bleeding events. Opportunities include the growing demand for effective antiplatelet therapies in PCI procedures, while threats include competition from other P2Y12 inhibitors and the need for careful patient selection to minimize bleeding risks[1].

Market Growth and Forecast

The market growth for KENGREAL is expected to be driven by its clinical efficacy and the increasing number of PCI procedures, especially in high-risk patient populations. The drug's unique pharmacokinetic profile makes it an attractive option for scenarios where oral P2Y12 inhibitors are not feasible or desirable. Forecasted sales figures indicate potential growth, although this will depend on various factors including market competition, pricing strategies, and healthcare economic analyses[1].

Patient Selection and Pharmacoeconomic Value

The pharmacoeconomic value of KENGREAL is optimized through careful patient selection. Studies have identified patient populations with high angiographic risk features as those who would benefit most from KENGREAL, leading to significant reductions in periprocedural events and associated costs. This targeted approach helps in maximizing the drug's efficacy while minimizing its financial impact on healthcare systems[4].

Regulatory and Safety Considerations

KENGREAL is contraindicated in patients with significant active bleeding and known hypersensitivity to cangrelor or any component of the product. The drug increases the risk of bleeding, which is a critical safety consideration. However, its quick offset of action after discontinuation is a safety advantage, particularly in emergency situations[2][4].

Conclusion

KENGREAL (cangrelor) is a valuable addition to the arsenal of antiplatelet therapies used in PCI procedures. Its market dynamics are influenced by its clinical efficacy, unique pharmacokinetic profile, and the financial implications of its use. While it faces competition from other P2Y12 inhibitors, its benefits in high-risk patient populations and potential cost savings make it a significant player in the cardiovascular drug market.

Key Takeaways

• Clinical Efficacy: KENGREAL reduces periprocedural thrombotic events in PCI patients.
• Market Competition: Competes with oral P2Y12 inhibitors but offers rapid onset and offset.
• Financial Impact: Potential cost savings from reduced periprocedural events and avoided delays in CABG surgery.
• Patient Selection: Optimal use in high-risk patient populations with high angiographic risk features.
• Safety Considerations: Increased risk of bleeding, but quick offset of action after discontinuation.

FAQs

Q: What is KENGREAL used for? A: KENGREAL (cangrelor) is used as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor[2].

Q: How does KENGREAL differ from other P2Y12 inhibitors? A: KENGREAL is an intravenous, direct-acting, reversible P2Y12 inhibitor with rapid onset and offset of action, differentiating it from oral P2Y12 inhibitors like clopidogrel, prasugrel, and ticagrelor[2].

Q: What are the safety concerns associated with KENGREAL? A: KENGREAL increases the risk of bleeding events, although it does not significantly increase severe bleeding or the need for transfusion. It is contraindicated in patients with significant active bleeding and known hypersensitivity to cangrelor or any component of the product[2][4].

Q: How does KENGREAL impact healthcare costs? A: Studies suggest that while KENGREAL has higher acquisition costs, it can lead to potential savings from reduced periprocedural event rates and avoided delays in CABG surgery due to the offset of action of P2Y12 inhibitor pretreatment[4][5].

Q: What patient population benefits most from KENGREAL? A: Patients with high angiographic risk features benefit most from KENGREAL, as it significantly reduces periprocedural thrombotic events in these high-risk cases[2][4].

Sources

1. DelveInsight Report: "Kengreal Drug Insight, 2019" - Valuates Reports.
2. KENGREAL Official HCP Site: KENGREAL® (cangrelor) | Official HCP Site.
3. Efficacy and Safety: Efficacy and Safety | KENGREAL® (cangrelor).
4. Chiesi USA Announcement: Chiesi USA Announces Publication of Cost-Consequence Analysis of KENGREAL® (cangrelor) - Biospace.
5. Financial Impact Analysis: Analysis of the Financial Impact of Using Cangrelor on the Safety and Cost of Care in Patients Undergoing PCI - PubMed.