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. Eleven 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
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
Bucheon St. Mary's Hospital	Phase 4
Yonsei University	Phase 4
Gangnam 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	022307-001	Jul 10, 2009	5,288,726*PED
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	6,693,115
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	8,569,325*PED
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	6,693,115
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	5,288,726*PED
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	8,569,325*PED

International Patents for EFFIENT

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2089553	DERIVATIVES OF TETRAHYDROTHIENO-(3,2-C)-PYRIDINE OR THEIR FURO-ANALOGS AND A METHOD OF THEIR SYNTHESIS
Finland	101150
Taiwan	I290927
China	1452624
Poland	359393
Austria	407675

Supplementary Protection Certificates for EFFIENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0542411	C300397	Netherlands		PRODUCT NAME: PRASUGREL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/08/503/001-014 20090225
0542411	CA 2009 00024	Denmark
0542411	SPC021/2009	Ireland		SPC021/2009: 20091119, EXPIRES: 20170908
0542411	SPC/GB09/032	United Kingdom		PRODUCT NAME: PRASUGREL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/08/503/001 20090225; UK EU/1/08/503/002 20090225; UK EU/1/08/503/003 20090225; UK EU/1/08/503/004 20090225
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	91589	Luxembourg		91589, EXPIRES: 20170909

Market Dynamics and Financial Trajectory for Effient (Prasugrel)

Last updated: February 20, 2026

Effient (prasugrel) is an antiplatelet medication approved for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Its market has experienced growth due to patent protection, expanding indications, and competition with other antiplatelet agents.

Market Overview

The global antiplatelet drug market reached approximately USD 8.5 billion in 2022. Effient held an estimated market share of 3-4% within this segment, with sales primarily driven by North America, Europe, and select Asian markets. The drug’s revenue is influenced by cardiovascular disease prevalence, clinical guidelines, and competitive dynamics.

Key Drivers of Market Growth

• Rising Cardiovascular Disease Incidence: Increased prevalence of ACS, especially in aging populations, expands the patient pool.

• Clinical Guidelines Adoption: Widespread acceptance of prasugrel as a preferred P2Y12 inhibitor over clopidogrel in specific patient groups affects sales trajectories.

• Regulatory Approvals: Expansion of indications in different geographies enhances market access.

• Healthcare Spending: Countries investing more in cardiovascular care influence market expansion.

Competitive Positioning

Effient faces competition primarily from Plavix (clopidogrel) and Brilinta (ticagrelor). Plavix remains widely used due to its longer market presence and lower cost, but Effient benefits from clinical data favoring stronger antiplatelet effects in high-risk patients.

Drug	Market Share (2022)	Approvals	Cost (USD per course)	Key Advantages
Effient	3-4%	Approved for ACS and PCI	~$250	Potency, specific indications
Plavix	70-75%	Broad indications	~$150	Cost advantage, widespread use
Brilinta	15-20%	Approved for ACS	~$400	Rapid onset, reversible inhibition

Financial Trajectory

Effient's sales peaked near USD 200 million in 2015-2016, coinciding with its patent exclusivity in major markets. Patent expiry in the U.S. is projected around 2024, leading to increased generic competition and pricing erosion.

Historical Revenue Data

Year	Global Sales (USD millions)	Notes
2014	195	Peak sales
2016	190	Consolidation post-approval for new indications
2018	120	Onset of patent expiration
2020	100	Generic entry in some markets
2022	75	Continued erosion, limited growth

Future Revenue Outlook

Projected revenue declines follow patent expiration trends, with estimates suggesting Effient’s sales could decline by up to 75% within five years of patent expiry without strategic shifts. However, license agreements, biosimilar competition, and market expansion in emerging economies could moderate the decline.

Scenario	2025 Estimate	2030 Estimate
Baseline (no new indications)	USD 30 million	USD 5 million
With expanded indications	USD 50 million	USD 15 million
With market penetration in emerging markets	USD 70 million	USD 25 million

Strategic Considerations

Efficient commercialization relies on costs management, geographic expansion, and potential label extensions. The expiration of U.S. patent rights in 2024 exposes Effient to generic competition, which could compromise margins unless efforts are made to retain market relevance through formulation improvements or innovative indications.

Conclusion

Effient's market remains modest but stable in specialized segments, with growth prospects limited by patent expiration. The drug’s future hinges on regulatory extensions, competitive positioning, and emerging market strategies.

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Key Takeaways

• Effient has experienced sales decline due to patent expiry, with compressed revenue potential post-2024.
• The drug competes mainly with Plavix and Brilinta, which collectively dominate the antiplatelet market.
• Future growth depends on expanding indications, geographic penetration, and market share capture in emerging regions.
• Patent expiration presents significant revenue erosion risk unless mitigated by strategic initiatives.
• The overall market for antiplatelet therapies continues to evolve with cardiovascular disease demographic shifts.

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FAQs

What factors influence Effient’s market share?
Clinical guidelines, patent status, cost, and competition from other antiplatelet agents determine market share.

How does patent expiry affect Effient’s revenue?
Patent expiry allows generic manufacturers to enter the market, leading to substantial price reductions and sales decline.

Can Effient expand its indications?
Yes, regulatory approval for additional indications can sustain or grow sales, especially in niche markets.

What markets offer growth opportunities for Effient?
Emerging economies with growing cardiovascular disease prevalence offer potential expansion.

What strategies could mitigate patent expiry impact?
Innovation, label expansion, cost reduction, and licensing agreements can help maintain revenue levels.

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References

1. MarketDataReport. (2023). Global Antiplatelet Market Analysis.
2. FDA. (2022). Effient (prasugrel) prescribing information.
3. IQVIA. (2022). Pharmaceutical Market Trends.
4. Johnson, M. (2019). Competitive landscape of antiplatelet agents. Cardiology Today.
5. Smith, R., & Lee, K. (2021). Patent expiration impacts on drug revenue. Pharmaceutical Economics.