PLETAL Drug Patent Profile

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

Pletal is a drug marketed by Otsuka and is included in one NDA.

The generic ingredient in PLETAL is cilostazol. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cilostazol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pletal

A generic version of PLETAL was approved as cilostazol by EPIC PHARMA LLC on November 23^rd, 2004.

Summary for PLETAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	20
Patent Applications:	4,227
DailyMed Link:	PLETAL at DailyMed

Recent Clinical Trials for PLETAL

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

Sponsor	Phase
Kangbuk Samsung Hospital	Phase 4
Asan Medical Center	Phase 4
University of Edinburgh	Phase 2

See all PLETAL clinical trials

US Patents and Regulatory Information for PLETAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-001	Jan 15, 1999		DISCN	Yes	No
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-002	Jan 15, 1999		DISCN	Yes	No

Expired US Patents for PLETAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-001	Jan 15, 1999
Otsuka	PLETAL	cilostazol	TABLET;ORAL	020863-002	Jan 15, 1999

International Patents for PLETAL

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

Country	Patent Number	Title	Estimated Expiration
Italy	7968748
Australia	538410
Canada	1139761	DERIVES DE TETRAZOLYLALCOXYCARBOSTYRYLE, ET METHODE DE FABRICATION (TETRAZOLYLALKOXYCARBOSTYRIL DERIVATIVES AND PROCESS FOR PRODUCING THE SAME)
Finland	792699
Spain	483792
Japan	S5535019	CARBOSTYRYL DERIVATIVE
Japan	S6155514

PLETAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PLETAL (Cilostazol)

Introduction

PLETAL, also known as cilostazol, is a pharmaceutical drug used primarily for the symptomatic relief of intermittent claudication, a condition associated with peripheral arterial disease (PAD). Here, we will delve into the market dynamics and financial trajectory of PLETAL, exploring its current market size, growth projections, and the factors influencing its market performance.

Market Size and Growth Projections

The global cilostazol market has been experiencing significant growth, driven by the increasing prevalence of chronic cardiovascular disorders, particularly PAD. As of 2023, the cilostazol market was valued at USD 1.45 billion. It is projected to reach USD 2.93 billion by 2031, growing at a compound annual growth rate (CAGR) of 8.2% from 2024 to 2031[3].

Market Segmentation

The cilostazol market is segmented based on several factors, including type (tablets, capsules), application (intermittent claudication, peripheral arterial disease, stroke prevention, coronary artery disease), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market needs and opportunities[3][4].

Key Drivers of Market Growth

Several factors are driving the growth of the cilostazol market:

Increasing Prevalence of Cardiovascular Disorders

The rising incidence of PAD and other cardiovascular conditions is a significant driver. As the global population ages and lifestyle factors contribute to increased cardiovascular risk, the demand for effective treatments like cilostazol is escalating[3].

Enhanced Medical Awareness

Medical professionals are becoming more aware of the benefits of cilostazol in improving blood flow and minimizing symptoms related to intermittent claudication. This increased awareness is leading to higher prescription rates and broader adoption of the drug[3].

Continuous Research and Development

Ongoing clinical trials and research are expanding the potential uses of cilostazol, further propelling market growth. New applications and combination therapies are being explored, which is expected to enhance the drug's therapeutic potential and market reach[3].

Early Detection and Preventative Care

The increased focus on early detection and preventative care in cardiovascular health is also contributing to the growth of the cilostazol market. As healthcare systems emphasize preventive measures, the demand for drugs like cilostazol that can manage and prevent the progression of cardiovascular diseases is increasing[3].

Market Restraints

Despite the positive growth trajectory, there are several restraints that could impact the market:

Contraindications and Adverse Reactions

PLETAL is contraindicated in patients with congestive heart failure of any severity due to its pharmacologic effect as a phosphodiesterase III inhibitor, which can decrease survival in such patients. Common adverse reactions include headache, diarrhea, palpitation, and dizziness, which can affect patient compliance and overall market growth[1][2].

Regulatory and Competitive Landscape

The pharmaceutical market is highly regulated, and changes in regulatory policies can impact the market. Additionally, competition from other antiplatelet agents and vasodilators can also pose a challenge to the growth of the cilostazol market[4].

Financial Performance and Projections

The financial performance of PLETAL is closely tied to its market size and growth. Here are some key financial aspects:

Revenue Growth

The revenue from cilostazol sales is expected to increase significantly over the forecast period, driven by the growing demand and expanding market size. The projected CAGR of 8.2% indicates a robust financial trajectory for the drug[3].

Key Players and Market Share

Major pharmaceutical companies such as Otsuka Pharmaceutical, Teva Pharmaceutical Industries, Mylan, Novartis, and Pfizer are key players in the cilostazol market. These companies are focusing on strengthening their product portfolios and expanding their business through strategic initiatives, which is expected to contribute to the overall financial growth of the market[3][4].

Geographical Analysis

The cilostazol market is geographically diverse, with significant contributions from regions such as North America, Europe, and Asia-Pacific. Each region has its own market dynamics, influenced by local healthcare policies, patient demographics, and economic factors. The Asia-Pacific region, in particular, is expected to show significant growth due to the large patient population and increasing healthcare expenditure[3][4].

Clinical and Therapeutic Impact

PLETAL's therapeutic impact is substantial, particularly in improving walking distances in patients with intermittent claudication. Clinical trials have demonstrated that PLETAL significantly improves walking distances and reduces symptoms associated with PAD. This clinical efficacy is a crucial factor driving its market growth and financial performance[1][2].

Conclusion

The market dynamics and financial trajectory of PLETAL (cilostazol) are characterized by robust growth driven by increasing demand, enhanced medical awareness, and continuous research and development. While there are restraints such as contraindications and adverse reactions, the overall outlook is positive, with the market projected to reach USD 2.93 billion by 2031.

Key Takeaways

• The global cilostazol market is valued at USD 1.45 billion as of 2023 and is expected to reach USD 2.93 billion by 2031.
• The market is growing at a CAGR of 8.2% from 2024 to 2031.
• Key drivers include the increasing prevalence of cardiovascular disorders, enhanced medical awareness, and continuous research and development.
• Contraindications and adverse reactions are significant restraints.
• Major pharmaceutical companies are key players in the market.

FAQs

What is PLETAL (cilostazol) used for?

PLETAL (cilostazol) is used for the symptomatic relief of intermittent claudication, a condition associated with peripheral arterial disease (PAD)[5].

What are the common adverse reactions associated with PLETAL?

Common adverse reactions include headache, diarrhea, palpitation, dizziness, and others. These reactions can lead to discontinuation of therapy in some patients[2].

Why is PLETAL contraindicated in patients with heart failure?

PLETAL is contraindicated in patients with congestive heart failure of any severity because it can decrease survival in such patients due to its pharmacologic effect as a phosphodiesterase III inhibitor[1][2].

What is the projected market size of the cilostazol market by 2031?

The cilostazol market is projected to reach USD 2.93 billion by 2031, growing at a CAGR of 8.2% from 2024 to 2031[3].

Which regions are expected to contribute significantly to the growth of the cilostazol market?

North America, Europe, and Asia-Pacific are expected to be significant contributors to the growth of the cilostazol market. The Asia-Pacific region, in particular, is anticipated to show substantial growth due to its large patient population and increasing healthcare expenditure[3][4].

Sources

1. FDA Label for PLETAL (cilostazol) - [Access Data FDA][1]
2. FDA Label for PLETAL (cilostazol) (Updated) - [Access Data FDA][2]
3. Cilostazol Market Size and Projections - [Market Research Intellect][3]
4. Cilostazol Market Report 2024 - [Cognitive Market Research][4]
5. Cilostazol: Uses, Interactions, Mechanism of Action - [DrugBank Online][5]