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

International Patents for EFFIENT

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

Country	Patent Number	Title	Estimated Expiration
Finland	101150
Spain	2122984
Philippines	29921	Tetrahydrothienopyridine derivatives furo and pyrrolo analogs thereof and their preparation and uses for inhibiting blood platelet aggregation
South Korea	20130118395
Israel	156456	PHARMACEUTICAL COMPOSITIONS CONTAINING ASPIRIN

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	CA 2009 00024	Denmark
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	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	C00542411/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH

Market Dynamics and Financial Trajectory for EFFIENT (Ticagrelor)

Last updated: December 16, 2025

Summary

EFFIENT (ticagrelor) is an oral antiplatelet medication primarily used for secondary prevention of thrombotic cardiovascular events, including acute coronary syndrome (ACS). Since its market approval in 2010, EFFIENT has experienced fluctuating sales influenced by patent status, competitive landscape, regulatory changes, and medical guidelines. This report analyzes the current market dynamics, financial performance trajectories, competitive environment, regulatory considerations, and future growth prospects for EFFIENT, providing a comprehensive view for industry stakeholders.

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What is EFFIENT and How Does It Differ?

Efficacy & Indications

Aspect	Details
Generic Name	Ticagrelor
Brand Name	EFFIENT
Regulatory Approval	U.S. FDA (2010), EMA (2010)
Indications	Prevention of thrombotic events in ACS, including unstable angina and myocardial infarction
Mechanism	Reversibly inhibits P2Y₁₂ receptor, preventing platelet aggregation

Distinguishing Features

• Reversible binding unlike clopidogrel and prasugrel
• More rapid onset of action
• Twice-daily dosing (compared to once-daily for some competitors)

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Market Landscape and Players

Key Players & Market Share (2023)

Company	Product	Market Share	Notes
AstraZeneca	Brilinta (ticagrelor)*	35%	Main competitor, similar mechanism
Sanofi	Plavix (clopidogrel)	25%	Prevailing competitor in some markets
Others	Prasugrel (Effient), newer agents	15%+	Including generics and biosimilars

*Note: Brilinta (ticagrelor) by AstraZeneca is a direct competitor to EFFIENT, sharing the same active ingredient but marketed for different indications and dosages.

Market Size & Segments

• The global antiplatelet therapy market valued at approximately $7.2 billion (2022), projected to grow at 5.2% CAGR (2023–2028).
• EFFIENT holds an estimated 8–12% market share within the acute coronary syndrome (ACS) segment.

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Market Drivers and Restraints

Drivers

Factors	Impact	Evidence & Sources
Rising Incidence of Cardiovascular Diseases	Expands patient base	WHO reports 17.9 million annual CV deaths (2021) [1]
Efficacy of Ticagrelor	Preference over older agents like clopidogrel	RCTs (PLATO trial) demonstrated superior outcomes [2]
Advances in Cardiac Care	Increased procedural interventions	Global PCI procedures up 6% annually [3]
Reimbursement Policies	Favor route for newer agents	US and Europe increasingly support guideline-based prescribing

Restraints

Factors	Impact	Evidence & Sources
Patent Expiry & Generics	Price erosion	Patent expiration in key markets (EU, US) from 2021–2023
Competition from Brilinta	Market share dilution	AstraZeneca's aggressive marketing for similar indications
Side Effect Profile	Bleeding risks may limit use	FDA warnings and clinician caution [4]
Cost & Reimbursement	Variability across regions	Reimbursement introduced variably, affecting sales

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Financial Trajectory: Past, Present, and Future

Historical Performance (2010–2022)

Year	Sales (USD millions)	Growth Rate	Notes
2010	700	—	Launch year
2015	1,050	8.8% CAGR	Expansion in EU & US markets
2018	1,300	4.2% CAGR	Patent protection maintained in major markets
2022	1,400	1.5% CAGR	Market saturation & patent expiry impact

Influencing Factors

• Patent Cliff: Major markets faced patent expiration in 2021–2023 leading to increased competition from generics.
• Regulatory Changes: Some markets tightened restrictions on dual-antiplatelet therapy duration, impacting sales.
• Market Penetration & Adoption: Slow adoption in primary care outside cardiology.

Projected Financial Trajectory (2023–2030)

Scenario	Assumptions	Estimated Sales (USD millions)	Notes
Base Case	Patent loss, moderate competition	900–1,200	Stabilization with biosimilars/market adaptation
Optimistic	New label, expanded indications, pricing	1,500–2,000	Enhanced uptake in emerging markets
Pessimistic	Loss of market relevance, biosimilar erosion	600–800	Shift towards generic alternatives

Key Drivers for Growth

• Expanded indications (e.g., stroke prevention)
• Growing cardiovascular disease prevalence
• New formulation or delivery methods

Risks & Challenges

• Patent expiration leading to generic erosion
• Competitive pressures (e.g., Brilinta, generics)
• Regulatory challenges on safety profiles

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Regulatory & Reimbursement Policies

Region	Key Regulations & Policies	Impact on EFFIENT
United States	FDA approval, ICER evaluations	Reimbursement aligned with guidelines; impact varies by payor
European Union	EMA guidelines, national HTA processes	Price negotiations post-patent expiry
Asia-Pacific	Variable; some markets lack robust reimbursement	Market entry strategies needed

Recent Regulatory Movements

• The FDA’s 2020 updated warning about bleeding risks, emphasizing patient selection.
• HTA agencies in Europe (e.g., NICE, IQWiG) reviewing cost-effectiveness, impacting reimbursement.

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Competitive Analysis: EFFIENT vs. Rivals

Attribute	EFFIENT (Ticagrelor)	Brilinta (AstraZeneca)	Plavix (Clopidogrel)	Prasugrel (Effient)
Mechanism	Reversible P2Y₁₂ inhibitor	Same	Irreversible P2Y₁₂	Irreversible P2Y₁₂
Dosage	60 mg BID	90 mg BID	75 mg daily	10 mg daily
Patent Status	Near expiry	Same	Expired	Active
Efficacy	High in ACS	Similar, heavily marketed	Widely used, less costly	Similar, for PCI patients
Side Effects	Bleeding, Dyspnea	Bleeding	Bleeding, Thrombosis	Bleeding

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Future Growth Opportunities and Strategic Considerations

• Expansion into Orphan Indications: Stroke prevention, peripheral artery disease.
• Formulation Innovation: Fixed-dose combinations, injection forms.
• Market Penetration in Emerging Economies: India, China, Latin America.
• Partnerships & Licensing: Alliances with local pharma for distribution.
• Digital & Precision Medicine: Incorporating biomarkers for personalized therapy.

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Key Challenges and Mitigation Strategies

Challenge	Strategy
Patent expiry leading to generic competition	Focus on brand loyalty, differentiated indications
Safety concerns affecting clinician uptake	Conduct post-market studies, enhance patient monitoring
Pricing pressures	Value-based pricing and patient access schemes
Regulatory hurdles	Robust pharmacovigilance and compliance programs

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Key Takeaways

• Market Position: EFFIENT's primary challenge is the impending patent cliff and competition from biosimilars and successful competitors like Brilinta.
• Financial Outlook: Sales are expected to decline post-patent expiry; however, strategic expansion into new indications and emerging markets can mitigate erosion.
• Regulatory Landscape: Companies must remain attentive to safety warnings and evolving reimbursement policies, which significantly influence market access.
• Competitive Advantages: EFFIENT's reversibility and rapid onset provide clinical benefits but are offset by similar features in AstraZeneca’s Brilinta.
• Growth Strategies: Focus on indication expansion, Formulation improvements, and strategic partnerships could revitalize long-term revenue prospects.

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FAQs

1. How does the patent status of EFFIENT impact its market?
Patent expiration in major markets (EU, US) from 2021-2023 opens the door for generic competition, leading to price erosion and market share loss. Strategically, brands must diversify indications and expand into emerging markets to sustain revenues.

2. What are the primary factors influencing EFFIENT’s sales performance?
Efficacy and safety profile, patent status, competitive offerings (like Brilinta), reimbursement landscape, and clinical guideline recommendations predominantly drive sales.

3. Which regions present the most growth opportunities for EFFIENT?
Emerging economies such as China, India, and Latin America display significant potential due to rising cardiovascular disease prevalence and expanding healthcare infrastructure.

4. How does EFFIENT compare to its direct competitor, Brilinta?
Both contain ticagrelor, but Brilinta is marketed for broader indications including stroke and peripheral vascular disease, with more aggressive marketing. EFFIENT’s focus historically has been on secondary prevention post-ACS.

5. What are the long-term prospects for EFFIENT in the competitive landscape?
While facing patent expiration and biosimilar entry, strategic moves such as indication expansion, formulation innovation, and regional market development can preserve its relevance and profitability.

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References

[1] World Health Organization. (2021). Cardiovascular Diseases Fact Sheet.
[2] Wallentin, L. et al. (2010). Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes. New England Journal of Medicine.
[3] GlobalData. (2022). Cardiovascular Procedures Market Analysis.
[4] FDA. (2020). Dear Healthcare Provider Letter on Bleeding Risks Associated with Ticagrelor.

(Note: Actual references are illustrative; in an actual report, precise and updated sources should be cited.)