CILOSTAZOL - Generic Drug Details

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

Cilostazol is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Apotex Inc, Aurobindo Pharma Usa, Chartwell Rx, Epic Pharma Llc, Hikma, Ivax Sub Teva Pharms, Nostrum Labs Inc, Pliva Hrvatska Doo, Rising, Slate Run Pharma, Teva, and Otsuka, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for cilostazol. Nine suppliers are listed for this compound.

Summary for CILOSTAZOL

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	15
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	136
Patent Applications:	6,718
Drug Prices:	Drug price trends for CILOSTAZOL
What excipients (inactive ingredients) are in CILOSTAZOL?	CILOSTAZOL excipients list
DailyMed Link:	CILOSTAZOL at DailyMed

See drug prices for CILOSTAZOL

See drug sales revenues for CILOSTAZOL

Recent Clinical Trials for CILOSTAZOL

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

Sponsor	Phase
Beijing Tiantan Hospital	Phase 2
NeuroDawn Pharmaceutical Co., Ltd.	Phase 2
Tanta University	Phase 3

See all CILOSTAZOL clinical trials

Pharmacology for CILOSTAZOL

Drug Class	Phosphodiesterase 3 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CILOSTAZOL

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

US Patents and Regulatory Information for CILOSTAZOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	CILOSTAZOL	cilostazol	TABLET;ORAL	077310-001	Nov 8, 2005		DISCN	No	No
Nostrum Labs Inc	CILOSTAZOL	cilostazol	TABLET;ORAL	077708-001	Sep 28, 2009		DISCN	No	No
Apotex Inc	CILOSTAZOL	cilostazol	TABLET;ORAL	077030-001	Dec 10, 2004	AB	RX	No	No
Rising	CILOSTAZOL	cilostazol	TABLET;ORAL	077323-002	Apr 20, 2006		DISCN	No	No
Ivax Sub Teva Pharms	CILOSTAZOL	cilostazol	TABLET;ORAL	077020-002	Mar 1, 2005		DISCN	No	No
Apotex Inc	CILOSTAZOL	cilostazol	TABLET;ORAL	077030-002	Dec 10, 2004	AB	RX	No	No

Expired US Patents for CILOSTAZOL

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

CILOSTAZOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cilostazol

Market Size and Projections

The cilostazol market is experiencing significant growth, driven by increasing demand for effective treatments for cardiovascular diseases. As of 2023, the cilostazol market size was valued at USD 1.45 billion and 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[1].

Key Drivers of Market Growth

Several factors are contributing to the expansion of the cilostazol market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of chronic cardiovascular disorders, particularly peripheral artery disease (PAD), is driving the demand for cilostazol. As the global population ages and the prevalence of these conditions increases, the need for efficient treatment alternatives like cilostazol grows[1].

Enhanced Medical Awareness

Increased awareness among medical professionals about the benefits of cilostazol in improving patient outcomes is another significant driver. Cilostazol's effectiveness in enhancing blood flow and minimizing symptoms related to intermittent claudication has made it a preferred choice[1].

Research and Development

Ongoing research and clinical trials are expanding the potential uses of cilostazol. Studies have shown its efficacy in various cardiovascular conditions, including stroke prevention, coronary artery disease, and the management of symptoms in patients undergoing stent implantation[2].

Combination Therapies

The development of combination medicines using cilostazol is further boosting its market reach. These combinations often include antiplatelet agents like clopidogrel and aspirin, which enhance the therapeutic potential of cilostazol[2].

Market Segmentation

The cilostazol market is segmented based on several criteria:

Type

The market is divided into tablets and capsules, with each form having its own market share and growth prospects[1].

Application

Cilostazol is used in various applications, including:

• Intermittent Claudication: It improves initial and absolute walking distances in patients with intermittent claudication secondary to PAD[5].
• Peripheral Arterial Disease (PAD): Cilostazol is effective in managing symptoms associated with PAD.
• Stroke Prevention: It has been studied for its potential in preventing strokes.
• Coronary Artery Disease: Cilostazol is used in the management of coronary artery disease, particularly in patients undergoing stent implantation[2].

Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory and market dynamics[1].

Competitive Landscape

The cilostazol market is competitive, with several key players:

• Otsuka Pharmaceutical
• Teva Pharmaceutical Industries
• Mylan
• Novartis
• Pfizer
• GlaxoSmithKline
• Johnson & Johnson
• Sanofi
• Merck & Co.
• Bayer
• Sun Pharmaceutical
• Lupin

These companies are focusing on expanding their product portfolios and strengthening their market positions through strategic initiatives[1].

Clinical Evidence and Safety

Cilostazol has been proven to be safe and effective in clinical trials. It improves walking distances in patients with intermittent claudication and has antiplatelet and antithrombotic properties. However, it can cause adverse effects such as headache, diarrhea, dizziness, and palpitations[5].

Economic Evaluation

From an economic perspective, cilostazol is compared to other vasoactive drugs. While it is effective, it may not always be the most cost-effective option. For instance, a study suggests that naftidrofuryl oxalate may have a better cost per Quality-Adjusted Life Year (QALY) gained compared to cilostazol[3].

Future Prospects and Trends

Early Detection and Preventative Care

The increasing focus on early detection and preventative care in cardiovascular health is expected to drive the demand for cilostazol further. As healthcare systems emphasize preventive measures, the market for cilostazol is likely to expand[1].

Technological and Research Advancements

Continuous research and development are expected to uncover new uses for cilostazol, further propelling market growth. Advances in combination therapies and the exploration of its potential in other cardiovascular conditions will be key drivers[2].

Regional Growth

The Asia-Pacific region is anticipated to show significant growth due to the large patient population and increasing healthcare expenditure. Other regions, such as North America and Europe, will also contribute to the market's expansion[1].

Key Takeaways

• The cilostazol market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases.
• Enhanced medical awareness and ongoing research are key drivers of market growth.
• The market is segmented by type, application, and geography, with various key players competing in the space.
• Cilostazol has been proven safe and effective in clinical trials but may have varying cost-effectiveness compared to other vasoactive drugs.
• Future prospects include increased focus on early detection and preventative care, as well as technological and research advancements.

FAQs

Q: What is the current market size of cilostazol and its projected growth? A: The cilostazol market size was valued at USD 1.45 billion in 2023 and is expected to reach USD 2.93 billion by 2031, growing at a CAGR of 8.2% from 2024 to 2031[1].

Q: What are the primary applications of cilostazol? A: Cilostazol is primarily used for intermittent claudication, peripheral arterial disease, stroke prevention, and coronary artery disease[1].

Q: Which regions are expected to show significant growth in the cilostazol market? A: The Asia-Pacific region, along with North America and Europe, is anticipated to show significant growth in the cilostazol market[1].

Q: What are the common adverse effects of cilostazol? A: Common adverse effects of cilostazol include headache, diarrhea, dizziness, and palpitations[5].

Q: How does cilostazol compare to other vasoactive drugs in terms of cost-effectiveness? A: Cilostazol may not always be the most cost-effective option compared to other vasoactive drugs like naftidrofuryl oxalate, which has a better cost per QALY gained[3].

Sources:

1. Market Research Intellect - Cilostazol Market Size and Projections
2. MDPI - The Role of Cilostazol, a Phosphodiesterase-3 Inhibitor
3. PubMed - A systematic review and economic evaluation of cilostazol
4. Cognitive Market Research - Cilostazol Market Report 2024 (Global Edition)
5. American Academy of Family Physicians - Cilostazol for Intermittent Claudication Caused by Peripheral Artery Disease