Prasugrel hydrochloride - Generic Drug Details

What are the generic drug sources for prasugrel hydrochloride and what is the scope of freedom to operate?

Prasugrel hydrochloride is the generic ingredient in three branded drugs marketed by Cosette, Accord Hlthcare, Amneal Pharms, Anda Repository, Aurobindo Pharma, Chartwell Rx, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for prasugrel hydrochloride. Eleven suppliers are listed for this compound.

Summary for prasugrel hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	238
Patent Applications:	184
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for prasugrel hydrochloride
What excipients (inactive ingredients) are in prasugrel hydrochloride?	prasugrel hydrochloride excipients list
DailyMed Link:	prasugrel hydrochloride at DailyMed

Recent Clinical Trials for prasugrel hydrochloride

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

Sponsor	Phase
Dolnolskie Centrum Chorb Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.	PHASE3
Medical Research Agency, Poland	PHASE3
J.P.S Henriques	PHASE4

See all prasugrel hydrochloride clinical trials

Pharmacology for prasugrel hydrochloride

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

Medical Subject Heading (MeSH) Categories for prasugrel hydrochloride

Platelet Aggregation Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for prasugrel hydrochloride

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for PRASUGREL HYDROCHLORIDE

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 prasugrel hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Panacea	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205897-002	Oct 16, 2017	AB	RX	No	No
Mylan	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205927-001	Jul 12, 2017	AB	RX	No	No
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	AB	RX	Yes	No
Aurobindo Pharma	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205888-002	Oct 16, 2017	AB	RX	No	No

Expired US Patents for prasugrel hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	8,404,703*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	8,569,325*PED
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	6,693,115

EU/EMA Drug Approvals for prasugrel hydrochloride

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Prasugrel Mylan	prasugrel	EMEA/H/C/004644Prasugrel Mylan, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).	Authorised	yes	no	no	2018-05-15
Substipharm	Efient	prasugrel	EMEA/H/C/000984Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).	Authorised	no	no	no	2009-02-24

Market Dynamics and Financial Trajectory for Prasugrel Hydrochloride

Last updated: July 27, 2025

Introduction

Prasugrel hydrochloride stands as a pivotal antiplatelet agent utilized predominantly in the management of acute coronary syndromes (ACS). Approved by the U.S. Food and Drug Administration (FDA) in 2009, prasugrel’s rapid onset of action and heightened efficacy compared to other antiplatelet drugs have cemented its role in cardiology. This report analyses the market dynamics and projected financial trajectory of prasugrel hydrochloride, considering factors such as competitive landscape, regulatory environment, clinical demand, patent lifecycle, and global trends.

---

Market Overview

Current Market Position

Prasugrel hydrochloride, marketed primarily under the brand name Effient by Eli Lilly and Co., occupies a significant niche within the antiplatelet drug segment. It competes mainly with clopidogrel (Plavix) and ticagrelor (Brilinta), which are more established in the market. Despite competition, prasugrel’s superior efficacy in certain patient populations has maintained a steady demand since its launch.

Patient Demographics and Clinical Adoption

Its primary indication is for patients with acute coronary syndromes undergoing percutaneous coronary intervention (PCI). The preference among cardiologists for prasugrel stems from clinical trial data demonstrating reduced ischemic events relative to older agents [1]. However, concerns over bleeding risks have limited widespread universal adoption, favoring selective prescription.

Regional Market Penetration

North America remains the dominant market, driven by high cardiovascular disease prevalence and advanced healthcare infrastructure. Europe follows, with increasing acceptance due to evolving clinical guidelines. Emerging markets in Asia-Pacific exhibit growth potential, supported by rising cardiovascular disease burden and expanding healthcare access.

---

Drivers of Market Dynamics

Clinical Efficacy and Safety Profile

Key to prasugrel’s market sustainability is its efficacy in reducing thrombotic events. The TRITON-TIMI 38 trial demonstrated its superiority over clopidogrel in reducing ischemic complications but noted an increased bleeding risk [2]. This balance influences prescribing behaviors and regulatory discourse.

Patent and Regulatory Environment

The drug’s patent protection significantly impacts market exclusivity. Eli Lilly’s patent on Effient was set to expire in 2023, opening avenues for generic competitors. However, patent litigations and formulations' exclusivities might extend or complicate generic entry, affecting revenue streams.

Competitive Landscape

The competition from ticagrelor, which offers reversible binding and ease of dosing, limits prasugrel’s market share growth. Generic availability of clopidogrel also exerts downward pressure on pricing and market share for newer agents.

Cost-Effectiveness and Reimbursement Policies

Insurance reimbursement and value-based healthcare initiatives influence adoption rates. Healthcare systems emphasizing cost-effectiveness favor drugs with proven efficacy, but also scrutinize bleeding risks and associated costs.

---

Financial Trajectory Analysis

Revenue Trends and Projections

Post-approval, prasugrel’s global sales exhibited initial rapid growth, reaching approximately $400 million annually at peak. As patents expired and generics entered markets, sales declined by approximately 10-15% annually in North America [3]. However, with ongoing clinical studies reaffirming safety and efficacy, new indications or label expansions could revitalize demand.

Impact of Patent Expiry and Generics

The impending patent expiration in 2023 is poised to significantly affect revenue. Generic entrants are likely to capture 70-80% of the market share due to price competitiveness, leading to substantial revenue erosion for branded formulations.

Strategic Opportunities

Potential growth avenues include expanding utilization to secondary preventive indications, such as stroke prevention, or combining prasugrel with emerging therapies. Additionally, formulation innovations (e.g., fixed-dose combinations) may generate renewed interest.

Future Market Growth Factors

An aging global population with increasing cardiovascular disease incidence is a long-term growth driver. Advances in personalized medicine, including pharmacogenomic profiling, could optimize prasugrel’s use, improving efficacy and safety, and thus market viability.

---

Market Challenges

Safety Concerns and Regulatory Scrutiny

Heightened awareness of bleeding risks necessitates careful patient selection, potentially limiting market expansion. Future regulatory frameworks may impose stricter guidelines, impacting prescribing patterns.

Pricing and Reimbursement Pressures

Cost containment measures, especially in public healthcare systems in Europe and Asia, exert downward pressure on drug prices. The entry of generics will further challenge profit margins.

Competition from Novel Agents

Emerging antiplatelet agents with distinct mechanisms or improved safety profiles could displace prasugrel in certain indications, influencing its market trajectory over the next decade.

---

Global Market Outlook

The next five years will witness restructuring of prasugrel’s market position due to patent challenges and competitive dynamics. While revenue decline is inevitable post-generic entry, sustained demand in niche populations and potential label expansions offer opportunities to mitigate losses.

The Asia-Pacific market, driven by rising cardiovascular disease burdens and healthcare infrastructure development, presents significant upside potential. Regulatory acceptance, local manufacturing capabilities, and pricing strategies will determine success levels.

---

Key Factors Influencing Future Financial Performance

• Patent Status: Expiration and legal exclusivities will dramatically impact revenue streams.
• Clinical Evidence: Ongoing trials assessing efficacy and safety may influence regulatory approvals and prescribing behaviors.
• Competitive Innovations: New antiplatelet agents with improved safety and convenience could reshape therapeutic paradigms.
• Market Penetration Strategies: Strategic partnerships and formulation innovations are critical to maintaining market relevance.

---

Key Takeaways

• Market Maturity and Patent Erosion: The imminent patent expiry in 2023 heralds a significant revenue decline unless offset by strategic initiatives.
• Competitive Pressures: Ticagrelor and generic clopidogrel are primary competitive forces, influencing pricing and market share.
• Regional Opportunities: Developing markets in Asia-Pacific offer growth potential, contingent upon regulatory approval and reimbursement frameworks.
• Risk-Benefit Balance: Safety concerns limit widespread adoption but sustain niche demand among high-risk populations.
• Innovation and Expansion: Label extensions and formulation improvements may provide incremental growth.

---

Conclusion

Prasugrel hydrochloride’s market and financial trajectory are characterized by a transition phase driven by patent expiration, competitive innovations, and evolving clinical practices. Though facing revenue declines due to generic competition, strategic positioning within emerging indications and geographic markets is crucial. Stakeholders must monitor regulatory developments, clinical trial outcomes, and market entry strategies to optimize long-term value from this key antiplatelet agent.

---

FAQs

1. When will prasugrel hydrochloride face generic competition, and what is the impact?
The pharmaceutical patent protecting Effient is expected to expire in 2023, paving the way for generic versions. This will likely lead to a substantial reduction in branded drug revenues, with market share shifting toward more affordable generics.

2. How does prasugrel compare to other antiplatelet agents in terms of efficacy and safety?
Clinical trials demonstrate that prasugrel offers superior efficacy in preventing ischemic events compared to clopidogrel but at the expense of a higher bleeding risk. Compared to ticagrelor, prasugrel’s reversible binding and dosing convenience differ, influencing clinician preferences.

3. What are the growth prospects for prasugrel in emerging markets?
Emerging markets in Asia-Pacific present expanding demand driven by increasing cardiovascular disease incidence. Market penetration depends on regulatory approvals, pricing strategies, and healthcare infrastructure enhancements.

4. Are there ongoing clinical trials that could expand prasugrel's approved indications?
Several studies are examining prasugrel's efficacy in secondary stroke prevention and other thrombotic conditions. Positive outcomes could lead to label extensions, fueling future growth.

5. What strategies can pharmaceutical companies employ post-patent expiry to sustain revenue?
Strategies include developing fixed-dose combination therapies, seeking new indications, optimizing pricing, pursuing regulatory approvals in new regions, and investing in formulation innovations.

---

References

[1] Wiviott, S. D., et al. (2007). Prasugrel versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine, 357(20), 2001-2015.

[2] Wiviott, S. D., et al. (2007). Safety and efficacy of prasugrel in patients with acute coronary syndromes. Circulation, 116(15), 1747-1757.

[3] MarketReportsWorld. (2022). Global Antiplatelet Drugs Market Report.