PRASUGREL Drug Patent Profile

Which patents cover Prasugrel, and when can generic versions of Prasugrel launch?

Prasugrel is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem. and is included in ten NDAs.

The generic ingredient in PRASUGREL 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 Prasugrel

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

Summary for PRASUGREL

US Patents:	0
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	226
Patent Applications:	1,365
Drug Prices:	Drug price information for PRASUGREL
DailyMed Link:	PRASUGREL at DailyMed

See drug prices for PRASUGREL

Recent Clinical Trials for PRASUGREL

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

Sponsor	Phase
Azienda Ospedaliera Universitaria Policlinico "G. Martino"	Phase 3
Gianluca Di Bella	Phase 3
Antonio Micari	Phase 3

See all PRASUGREL clinical trials

Pharmacology for PRASUGREL

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

Anatomical Therapeutic Chemical (ATC) Classes for PRASUGREL

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

US Patents and Regulatory Information for PRASUGREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205987-001	Feb 2, 2018	AB	RX	No	No
Panacea	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205897-002	Oct 16, 2017	AB	RX	No	No
Chartwell Rx	PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205790-001	Oct 16, 2017		DISCN	No	No

EU/EMA Drug Approvals for PRASUGREL

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Prasugrel Hydrochloride

Introduction

Prasugrel hydrochloride, an antiplatelet medication, has been gaining significant traction in the pharmaceutical market due to its efficacy in managing cardiovascular diseases. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key drivers, market size, and future projections.

Market Size and Projections

The prasugrel hydrochloride market was valued at USD 1200 million in 2023 and is projected to reach USD 2500 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8% from 2024 to 2031[1][4].

Key Drivers of the Market

Rising Incidence of Cardiovascular Diseases

Cardiovascular diseases are the leading cause of mortality worldwide, accounting for approximately 17.9 million deaths annually. This rising incidence drives the demand for effective therapeutic solutions like prasugrel hydrochloride[4].

Aging Population

The aging population, particularly in industrialized countries, is more susceptible to cardiovascular diseases such as acute coronary syndrome (ACS) and ischemic heart disease. This demographic shift increases the need for antiplatelet medications like prasugrel hydrochloride[1].

Therapeutic Efficacy

Prasugrel hydrochloride has proven to be more effective than traditional antiplatelet therapies in certain patient populations, offering better outcomes in terms of reduced hospitalization rates and improved survival rates. This efficacy reinforces its adoption in clinical practice[4].

Advancements in Drug Formulations

Innovations in drug delivery mechanisms, such as sustained-release formulations, are enhancing the efficacy and patient compliance of prasugrel hydrochloride. These advancements are expected to significantly boost market growth[4].

Expanding Access to Healthcare

Improvements in healthcare infrastructure in emerging economies and favorable government policies are making prasugrel hydrochloride more accessible. This expansion is particularly notable in regions like Asia-Pacific and Latin America[4].

Market Segmentation

The prasugrel hydrochloride market is segmented based on application, product, and geographical regions.

Application

• Acute Coronary Syndrome (ACS)
• Percutaneous Coronary Intervention (PCI)
• Thrombosis Prevention
• Ischemic Heart Disease

These applications highlight the drug's versatility and critical role in cardiovascular disease management[1].

Product

• Tablets
• Oral Solution

The availability of different formulations caters to various patient needs and preferences[1].

Geographical Regions

• North America
• Europe
• Asia-Pacific
• South America
• Middle-East and Africa

Each region presents unique market dynamics influenced by local healthcare policies, economic conditions, and disease prevalence[1].

Financial Performance and Projections

Revenue Growth

The market's revenue growth is driven by the increasing demand for prasugrel hydrochloride, particularly in emerging markets. The projected growth from USD 1200 million in 2023 to USD 2500 million by 2031 underscores the market's potential[1][4].

Cost-Effectiveness

Studies have shown that prasugrel hydrochloride is an economically attractive treatment strategy compared to clopidogrel. It is associated with lower rehospitalization rates and life expectancy gains, making it a cost-effective option in the long term[5].

Strategic Partnerships and Innovations

Pharmaceutical companies are engaging in strategic partnerships to expand their product portfolios and improve access to prasugrel hydrochloride. Innovations in pharmaceutical manufacturing, such as the use of green chemistry and AI-driven drug development, are reducing production costs and accelerating market growth[4].

Regulatory Environment

Expedited Approvals

Regulatory bodies in regions with high CVD prevalence are expediting approvals for prasugrel hydrochloride, facilitating its rapid adoption. Favorable reimbursement policies in various countries also contribute to the market's expansion[4].

Emerging Markets

Asia and Africa

Emerging markets in Asia and Africa are experiencing a surge in demand for cardiovascular drugs due to increasing urbanization, changing lifestyles, and rising healthcare awareness. Manufacturers are capitalizing on these trends to expand their market presence[4].

Conclusion

The prasugrel hydrochloride market is poised for substantial growth driven by the rising prevalence of cardiovascular diseases, continuous innovation, and expanding access to healthcare globally. As more countries adopt advanced treatment protocols, the market's significance will only increase, offering promising opportunities for stakeholders.

Key Takeaways

• The prasugrel hydrochloride market is projected to grow from USD 1200 million in 2023 to USD 2500 million by 2031.
• The rising incidence of cardiovascular diseases and the aging population are key drivers of the market.
• Innovations in drug formulations and expanding access to healthcare in emerging economies are boosting market growth.
• Prasugrel hydrochloride is a cost-effective treatment strategy compared to traditional antiplatelet medications.
• Strategic partnerships and advancements in pharmaceutical manufacturing are critical for market expansion.

FAQs

What is the current market size of prasugrel hydrochloride, and what are its future projections?

The prasugrel hydrochloride market was valued at USD 1200 million in 2023 and is expected to reach USD 2500 million by 2031, growing at a CAGR of 8% from 2024 to 2031[1][4].

What are the main drivers of the prasugrel hydrochloride market?

The main drivers include the rising incidence of cardiovascular diseases, the aging population, therapeutic efficacy, advancements in drug formulations, and expanding access to healthcare in emerging economies[1][4].

How does prasugrel hydrochloride compare to other antiplatelet medications in terms of cost-effectiveness?

Prasugrel hydrochloride is associated with lower rehospitalization rates and life expectancy gains compared to clopidogrel, making it an economically attractive treatment strategy[5].

What role do strategic partnerships play in the prasugrel hydrochloride market?

Strategic partnerships between pharmaceutical companies are fostering innovation, expanding product portfolios, and improving access to prasugrel hydrochloride, particularly in underserved regions[4].

Which regions are experiencing the most significant growth in the prasugrel hydrochloride market?

Emerging markets in Asia and Africa are experiencing significant growth due to increasing urbanization, changing lifestyles, and rising healthcare awareness[4].

Sources

1. Market Research Intellect, "Prasugrel Hydrochloride Market Size and Projections," December 2024.
2. DAIICHI SANKYO CO., LTD., "Annual Report," 2008-07-31.
3. Euroland, "A Future of Innovation," 2007-2008.
4. Market Research Intellect, "Prasugrel Hydrochloride Market: Paving the Way for Advanced Cardiovascular Care," November 22, 2024.
5. PubMed, "Cost-effectiveness of prasugrel versus clopidogrel in patients with acute coronary syndromes," December 21, 2009.