EFFIENT Drug Patent Profile

Which patents cover Effient, and what generic alternatives are available?

Effient is a drug marketed by Cosette and is included in one NDA.

The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Effient

A generic version of EFFIENT was approved as prasugrel hydrochloride by UNICHEM on August 28^th, 2023.

Summary for EFFIENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	51
Patent Applications:	1,365
Drug Prices:	Drug price information for EFFIENT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFFIENT
What excipients (inactive ingredients) are in EFFIENT?	EFFIENT excipients list
DailyMed Link:	EFFIENT at DailyMed

See drug prices for EFFIENT

See drug sales revenues for EFFIENT

Recent Clinical Trials for EFFIENT

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

Sponsor	Phase
Yonsei University	Phase 4
Gangnam Severance Hospital	Phase 4
Severance Hospital	Phase 4

See all EFFIENT clinical trials

Pharmacology for EFFIENT

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Paragraph IV (Patent) Challenges for EFFIENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EFFIENT	Tablets	prasugrel hydrochloride	5 mg and 10 mg	022307	17	2013-07-10

US Patents and Regulatory Information for EFFIENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	AB	RX	Yes	No
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	AB	RX	Yes	Yes

Expired US Patents for EFFIENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009

International Patents for EFFIENT

See the table below for patents covering EFFIENT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2002255814	PHARMACEUTICAL COMPOSITION COMPRISING ASPIRIN
Taiwan	I293249
World Intellectual Property Organization (WIPO)	0204461
Mexico	PA03000031	SALES ACIDAS DE ADICION DE DERIVADOS DE HIDROPIRIDINA. (HYDROPYRIDINE DERIVATIVE ACID ADDITION SALTS.)
Denmark	1298132

Supplementary Protection Certificates for EFFIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0542411	SPC021/2009	Ireland		SPC021/2009: 20091119, EXPIRES: 20170908
0542411	09C0031	France		PRODUCT NAME: PRASUGREL; NAT. REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225; FIRST REGISTRATION: EU/1/08/503/001/-014 20090225
0542411	CA 2009 00024	Denmark
0542411	C00542411/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0542411	300397	Netherlands		300397, 20120909, EXPIRES: 20170908

EFFIENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Effient

Introduction

Effient, also known as prasugrel, is an oral antiplatelet agent used to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) who are managed with percutaneous coronary intervention (PCI). Here, we delve into the market dynamics and financial trajectory of Effient, highlighting its key aspects and future projections.

Market Size and Growth

The global antiplatelet market, which includes Effient, is expected to grow significantly. By 2030, the global antiplatelet market is projected to reach $5.1 billion, growing at a CAGR of 4.7% from 2023 to 2030[1].

Segment Analysis

By Drug Class

Effient falls under the category of Adenosine diphosphate (ADP) Receptor Inhibitors, which dominated the antiplatelet market by drug class in 2022. This segment is expected to achieve a market value of $3.4 billion by 2030, indicating strong demand for ADP receptor inhibitors like Effient[1].

By Distribution Channel

The distribution of Effient is primarily through drug stores and retail pharmacies, which accounted for the maximum revenue share in 2022. This channel ensures high accessibility and contributes to medication safety, education, and adherence[1].

Cost-Effectiveness and Economic Impact

Comparative Analysis with Clopidogrel

Studies have shown that Effient is highly cost-effective compared to clopidogrel. A cost-effectiveness analysis involving 6,705 patients found that treatment with Effient reduced total hospitalization costs by $530 per patient over approximately 15 months, excluding the cost of study drugs. Including the costs of the study drugs, Effient decreased cumulative medical costs by $221 per patient over 14.7 months compared to clopidogrel[2].

Economic Dominance

Effient is considered economically dominant, meaning it offers greater clinical effectiveness at lower costs. This is particularly significant for healthcare formulary decision-makers, as it provides new data on the cost-effectiveness of Effient for patients with ACS undergoing PCI[2].

Clinical Benefits and Safety Profile

Clinical Efficacy

Effient, when used in combination with aspirin, significantly reduces the rate of cardiovascular death, nonfatal heart attacks, and nonfatal strokes compared to clopidogrel plus aspirin. It also reduces stent thromboses, which are critical benefits for patients undergoing PCI[2].

Safety Considerations

While Effient offers significant clinical benefits, it also increases the risk of bleeding, which can be serious or even fatal in some cases. Patients with a history of stroke, transient ischemic attack (TIA), or conditions that cause bleeding should avoid using Effient[2].

Regional Market Performance

North America

The North America region, particularly the United States, is a key market for Effient. This region has a high prevalence of cardiovascular diseases, which drives the demand for antiplatelet therapies. In 2022, North America generated the highest revenue share in the global antiplatelet market[1].

Competitive Landscape

Effient is co-developed by Daiichi Sankyo Company, Limited, and Eli Lilly and Company. The competitive landscape includes other major players such as AstraZeneca PLC, Bayer AG, and Sanofi S.A. The market is highly competitive, with multiple antiplatelet agents available, but Effient's unique clinical benefits and cost-effectiveness position it favorably[1].

Future Projections

Market Growth

The U.S. P2Y12 inhibitors market, which includes Effient, is expected to grow at a CAGR of 3.8% from 2021 to 2028, reaching a market size of $279.6 million by 2028. This growth is driven by the increasing prevalence of cardiovascular diseases and the need for effective antiplatelet therapies[4].

Financial Trajectory

Given its cost-effectiveness and clinical benefits, Effient is likely to continue contributing significantly to the financial performance of its developers. The drug's ability to reduce hospitalization costs and its economic dominance over other treatments like clopidogrel will be key factors in its financial trajectory.

Key Takeaways

• Market Growth: The global antiplatelet market, including Effient, is projected to reach $5.1 billion by 2030.
• Cost-Effectiveness: Effient is highly cost-effective compared to clopidogrel, reducing hospitalization and medical costs.
• Clinical Benefits: Effient significantly reduces cardiovascular events and stent thromboses but comes with a higher risk of bleeding.
• Regional Performance: North America is a key market for Effient due to the high prevalence of cardiovascular diseases.
• Competitive Landscape: Effient competes with other antiplatelet agents but stands out due to its clinical and economic benefits.

FAQs

What is Effient used for?

Effient is used to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) who are managed with percutaneous coronary intervention (PCI).

How does Effient compare to clopidogrel in terms of cost-effectiveness?

Effient is highly cost-effective compared to clopidogrel, reducing total hospitalization costs and cumulative medical costs over the treatment period[2].

What are the safety considerations for Effient?

Effient increases the risk of bleeding, which can be serious or fatal. Patients with a history of stroke, TIA, or conditions that cause bleeding should avoid using Effient[2].

Which regions are key markets for Effient?

North America, particularly the United States, is a key market for Effient due to the high prevalence of cardiovascular diseases[1].

What is the projected market size for the U.S. P2Y12 inhibitors market by 2028?

The U.S. P2Y12 inhibitors market, which includes Effient, is expected to reach $279.6 million by 2028, growing at a CAGR of 3.8% from 2021 to 2028[4].

Sources

1. KBV Research: "Antiplatelet Market Size, Trends Analysis and Forecast, 2030"
2. Eli Lilly and Company: "New Analysis Showed Effient(R) Cost-Effective Compared with Clopidogrel"
3. Vermont Legislature: "Medicines Use and Spending Shifts"
4. Coherent Market Insights: "U.S. P2Y12 Inhibitors Market Size and Forecast to 2028"