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, Aurobindo Pharma, Chartwell Rx, Dr Reddys, 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. Ten 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:	10
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	226
Patent Applications:	121
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
Giampiero Vizzari	Phase 3
Giorgio Quadri	Phase 3
Ferdinando Varbella	Phase 3

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
Lupin Ltd	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205930-001	Jan 9, 2023		DISCN	No	No
Hec Pharm	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	206021-002	Jan 16, 2019	AB	RX	No	No
Accord Hlthcare	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205987-002	Feb 2, 2018	AB	RX	No	No
Unichem	PRASUGREL HYDROCHLORIDE	prasugrel hydrochloride	TABLET;ORAL	213315-001	Aug 28, 2023	AB	RX	No	No
Hec Pharm	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	206021-001	Jan 16, 2019	AB	RX	No	No
Mylan	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205927-002	Jul 12, 2017	AB	RX	No	No
Amneal Pharms	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205913-001	Jun 19, 2018	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	5,288,726*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	8,404,703*PED
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	6,693,115
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	8,404,703*PED
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	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/004644 Prasugrel 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/000984 Efient, 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

Prasugrel hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prasugrel Hydrochloride

Introduction

Prasugrel hydrochloride, a thienopyridine adenosine diphosphate (ADP) receptor antagonist, is widely used for the reduction of atherothrombotic events and stent thrombosis in acute coronary syndromes. Here, we delve into the market dynamics and financial trajectory of this crucial pharmaceutical.

Market Size and Growth

The global prasugrel hydrochloride market has shown significant growth in recent years. As of 2023, the market size was valued at several million dollars, with a projected compound annual growth rate (CAGR) that indicates robust expansion from 2024 to 2031[1][4].

Key Market Segments

Type

The market is segmented based on the type of prasugrel hydrochloride, primarily into 5mg and 10mg formulations. The 5mg segment has accounted for a noticeable share of the global market and is expected to experience significant growth in the near future[1][4].

Application

Prasugrel hydrochloride is predominantly used in hospitals and drug stores. The hospital segment is anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[1][4].

Regional Analysis

The market is analyzed across five major regions: North America, Europe, Asia-Pacific, and South America. Each region has its unique market trends, drivers, and restraints. For instance, North America is a key market due to its advanced healthcare infrastructure and high demand for antiplatelet therapies[1].

Market Drivers

Several factors drive the growth of the prasugrel hydrochloride market:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of acute coronary syndromes and the need for effective antiplatelet therapies are major drivers.
• Advancements in Healthcare Infrastructure: Improved healthcare facilities and increased access to medical treatments in developing regions contribute to market growth.
• Strategic Initiatives by Key Players: Companies like Daiichi Sankyo, Apotex, and Amneal Pharmaceuticals are focusing on expanding their product portfolios and business presence globally[1][4].

Market Restraints

Despite the growth, the market faces several challenges:

• Regulatory Hurdles: Strict regulatory requirements, especially for bioequivalence studies, can slow down the approval process for generic versions of prasugrel hydrochloride[2].
• Side Effects and Safety Concerns: Prasugrel hydrochloride can have side effects such as increased bleeding risk, which may limit its adoption in certain patient populations[3].
• Competition from Other Antiplatelet Drugs: The presence of other antiplatelet agents, such as clopidogrel, can pose a competitive threat to prasugrel hydrochloride[3].

Competitive Landscape

The market is highly competitive, with several key players:

• Daiichi Sankyo: The original developer of prasugrel hydrochloride, known for its strong market presence.
• Apotex: A significant player in the generic market.
• Amneal Pharmaceuticals: Known for its extensive product portfolio and strategic expansions.
• Other Players: Ube, Ascend Laboratories, Liberty Pharmaceuticals, and Panacea Biotec are also notable competitors[1][4].

Financial Trajectory

The financial trajectory of the prasugrel hydrochloride market is promising:

• Revenue Forecast: The market is expected to reach several million dollars by 2030, driven by increasing demand and expanding applications[4].
• CAGR: The market is anticipated to grow at a significant CAGR from 2024 to 2031, indicating a robust financial outlook[1][4].
• Regional Revenue: The revenue is forecasted to grow across all major regions, with North America and Europe being the leading contributors due to their well-established healthcare systems[1].

Technological and Regulatory Trends

Bioequivalence Guidance

The European Medicines Agency (EMA) has provided specific bioequivalence guidance for prasugrel hydrochloride, emphasizing the need for detailed pharmacokinetic studies, especially under fed conditions if the generic product differs from the originator[2].

Pharmacokinetics and Metabolism

Prasugrel hydrochloride is a pro-drug that undergoes metabolic conversion to its active form. The pharmacokinetics, including absorption and metabolism, are critical for its efficacy and safety profile. Factors such as gastric pH and concomitant administration of other drugs can affect its plasma concentrations[3].

Market Opportunities

Expanding into Emerging Markets

There is a significant opportunity for growth in emerging markets where healthcare infrastructure is improving and the demand for cardiovascular treatments is increasing.

Generic Market

The expiration of patents for prasugrel hydrochloride has opened up opportunities for generic manufacturers to enter the market, which can drive competition and reduce prices, making the drug more accessible to a broader patient population[1][4].

Challenges and Future Outlook

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the market. While it has disrupted supply chains, it has also highlighted the importance of cardiovascular health, potentially increasing demand for antiplatelet therapies in the long term[1].

Future Research Directions

Future research is expected to focus on improving the safety profile of prasugrel hydrochloride, exploring new formulations, and enhancing its pharmacokinetic properties to better serve patient needs[3].

"Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance emphasizes the need for detailed pharmacokinetic studies to ensure the efficacy and safety of generic versions"[2].

Key Takeaways

• The global prasugrel hydrochloride market is expected to grow significantly from 2024 to 2031.
• The 5mg and 10mg formulations are the primary types, with the hospital segment being a major application area.
• Key drivers include the increasing prevalence of cardiovascular diseases and advancements in healthcare infrastructure.
• Regulatory hurdles and competition from other antiplatelet drugs are significant restraints.
• The market is highly competitive, with Daiichi Sankyo, Apotex, and Amneal Pharmaceuticals being key players.

FAQs

What is the primary use of prasugrel hydrochloride?

Prasugrel hydrochloride is primarily used for the reduction of atherothrombotic events and stent thrombosis in acute coronary syndromes.

Which companies are the main players in the prasugrel hydrochloride market?

The main players include Daiichi Sankyo, Apotex, Amneal Pharmaceuticals, Ube, Ascend Laboratories, Liberty Pharmaceuticals, and Panacea Biotec.

What are the key segments of the prasugrel hydrochloride market?

The market is segmented by type (5mg and 10mg) and application (hospitals and drug stores).

What are the major drivers of the prasugrel hydrochloride market?

The increasing prevalence of cardiovascular diseases, advancements in healthcare infrastructure, and strategic initiatives by key players are major drivers.

What are the potential restraints for the prasugrel hydrochloride market?

Regulatory hurdles, side effects and safety concerns, and competition from other antiplatelet drugs are significant restraints.

Sources

1. Cognitive Market Research: Global Prasugrel Hydrochloride Market Report 2024.
2. European Medicines Agency: Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance.
3. FDA: CENTER FOR DRUG EVALUATION AND RESEARCH - Prasugrel Hydrochloride.
4. Valuates Reports: Global Prasugrel Hydrochloride Market Research Report 2024.