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Last Updated: December 26, 2024

CILOSTAZOL Drug Patent Profile


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Which patents cover Cilostazol, and what generic alternatives are available?

Cilostazol is a drug 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, and Teva. and is included in fourteen NDAs.

The generic ingredient in CILOSTAZOL 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 Cilostazol

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

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Drug patent expirations by year for CILOSTAZOL
Drug Prices for CILOSTAZOL

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Drug Sales Revenue Trends for CILOSTAZOL

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Recent Clinical Trials for CILOSTAZOL

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

SponsorPhase
Beijing Tiantan HospitalPhase 2
NeuroDawn Pharmaceutical Co., Ltd.Phase 2
Misr International UniversityPhase 2/Phase 3

See all CILOSTAZOL clinical trials

Pharmacology for CILOSTAZOL

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
Actavis Elizabeth CILOSTAZOL cilostazol TABLET;ORAL 077028-002 Nov 26, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pliva Hrvatska Doo CILOSTAZOL cilostazol TABLET;ORAL 077898-002 Oct 29, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva CILOSTAZOL cilostazol TABLET;ORAL 077027-002 Nov 24, 2004 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx CILOSTAZOL cilostazol TABLET;ORAL 077831-002 Sep 24, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Usa CILOSTAZOL cilostazol TABLET;ORAL 077019-001 Nov 23, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma CILOSTAZOL cilostazol TABLET;ORAL 077024-001 May 17, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising CILOSTAZOL cilostazol TABLET;ORAL 077323-001 Apr 20, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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