Suppliers and packagers for generic pharmaceutical drug: CILOSTAZOL

CILOSTAZOL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	CILOSTAZOL	cilostazol	TABLET;ORAL	077030	ANDA	AvKARE	42291-453-60	60 TABLET in 1 BOTTLE (42291-453-60)	2022-04-12
Apotex	CILOSTAZOL	cilostazol	TABLET;ORAL	077030	ANDA	AvPAK	50268-176-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-176-15) / 1 TABLET in 1 BLISTER PACK (50268-176-11)	2016-10-18
Apotex	CILOSTAZOL	cilostazol	TABLET;ORAL	077030	ANDA	AvPAK	50268-177-15	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-177-15) / 1 TABLET in 1 BLISTER PACK (50268-177-11)	2016-10-18

CILOSTAZOL SUPPLIERS AND INTELLECTUAL PROPERTY LANDSCAPE

Last updated: February 19, 2026

This report details key suppliers of Cilostazol and analyzes the patent landscape impacting its market. Manufacturers are identified, alongside their reported capabilities. Patent expiration dates and significant litigation events are presented to inform strategic R&D and investment.

KEY CILOSTAZOL SUPPLIERS IDENTIFIED

Several manufacturers globally supply Cilostazol, a phosphodiesterase III inhibitor used to treat the symptoms of intermittent claudication. These suppliers operate within a competitive environment shaped by patent expirations and regulatory approvals.

• Major Manufacturers:

  • Aurobindo Pharma: An India-based pharmaceutical company with manufacturing sites approved by major regulatory bodies including the US FDA and European Medicines Agency. Aurobindo is a significant player in the generics market and supplies active pharmaceutical ingredients (APIs) and finished dosage forms.
  • Lupin Limited: Another prominent Indian pharmaceutical company. Lupin has a global presence and a broad portfolio of generic drugs. Its manufacturing facilities adhere to international quality standards.
  • Dr. Reddy's Laboratories: A multinational pharmaceutical company headquartered in India. Dr. Reddy's is known for its generic and biosimilar products, and it actively participates in API manufacturing.
  • Teva Pharmaceutical Industries: A global leader in generic medicines, headquartered in Israel. Teva's extensive supply chain and manufacturing network position it as a key supplier.
  • Mylan N.V. (now Viatris): Following the merger of Mylan and Upjohn, Viatris is a significant global pharmaceutical entity. It manufactures and distributes a wide range of generic and specialty products, including cardiovascular drugs.
  • Sun Pharmaceutical Industries: India's largest pharmaceutical company and a global manufacturer. Sun Pharma's operations encompass API production and finished formulations.

• Other Noteworthy Suppliers:

  • Hetero Drugs: A privately held Indian pharmaceutical company with substantial API manufacturing capacity.
  • Torrent Pharmaceuticals: An Indian multinational specializing in generics and branded generics.

Table 1: Selected Cilostazol API Suppliers and Reported Capabilities

Supplier Name	Country of Origin	FDA Approved Site(s)	EMA Approved Site(s)	Notes
Aurobindo Pharma	India	Yes	Yes	Broad API and finished dosage form portfolio.
Lupin Limited	India	Yes	Yes	Strong global presence in generics.
Dr. Reddy's Laboratories	India	Yes	Yes	Active in API development and manufacturing.
Teva Pharmaceutical Industries	Israel	Yes	Yes	Extensive global supply chain and manufacturing footprint.
Viatris	United States	Yes	Yes	Formed by Mylan and Upjohn merger, significant generic drug provider.
Sun Pharmaceutical Industries	India	Yes	Yes	Largest pharmaceutical company in India by market capitalization.
Hetero Drugs	India	Yes	Yes	Significant API producer, often a key supplier for other formulators.
Torrent Pharmaceuticals	India	Yes	Yes	Focus on generics and branded generics in various therapeutic areas.

Data compiled from company reports and regulatory filings. Specific site approvals may vary by product and date.

PATENT LANDSCAPE AND MARKET EXCLUSIVITY

The patent landscape for Cilostazol is critical for understanding market entry strategies and potential for generic competition. The original patent for Cilostazol has long expired, opening the door for multiple generic manufacturers. However, secondary patents related to specific formulations, polymorphic forms, or manufacturing processes can still offer periods of exclusivity.

The originator drug for Cilostazol is Pletal, originally developed by Otsuka Pharmaceutical. The compound was first patented in the early 1980s.

• Key Patent Expirations:
  • US Patent 4,547,514: This fundamental patent covering Cilostazol composition of matter expired in the early 2000s. This date marked a significant turning point, allowing for widespread generic manufacturing.
  • European Patent EP0090250B1: The corresponding European patent also expired, facilitating market entry across the continent.

The expiration of primary composition of matter patents allows for generic versions to enter the market. This often leads to a significant decrease in drug prices and an increase in market volume.

FORMULATION AND PROCESS PATENTS

While the core compound patent has expired, pharmaceutical companies have pursued patents on specific aspects of Cilostazol drug products. These can include:

• Polymorphic Forms: Different crystalline structures of an API can have varying physical properties (e.g., solubility, stability). Patents covering specific, advantageous polymorphic forms can extend market exclusivity. For Cilostazol, research has explored different polymorphs, and patents have been granted on certain stable crystalline forms. For example, patents have described crystalline forms of Cilostazol characterized by specific X-ray powder diffraction patterns and thermal properties. [1]
• Formulation Patents: These patents protect specific drug delivery systems or formulations that enhance efficacy, reduce side effects, or improve patient compliance. This could include extended-release formulations, specific tablet compositions, or granulation techniques.
• Manufacturing Process Patents: Novel or improved methods for synthesizing Cilostazol, particularly those that are more cost-effective, efficient, or environmentally friendly, can be patented.

Impact of Secondary Patents: Companies that hold valid patents on improved formulations or manufacturing processes can delay or challenge generic entries. Generic manufacturers must carefully analyze these secondary patents to ensure their products do not infringe. This often involves:

1. Freedom-to-Operate (FTO) Analysis: Thorough reviews of existing patents to confirm that a planned generic product does not infringe any valid claims.
2. Patent Litigation: Generic companies may challenge the validity or enforceability of secondary patents, leading to costly legal battles. Conversely, originator companies may sue generic manufacturers for patent infringement.

SIGNIFICANT LITIGATION AND REGULATORY ACTIONS

Litigation surrounding generic drug approvals, particularly Paragraph IV certifications under the Hatch-Waxman Act in the United States, is common. These actions allow generic companies to challenge patents and seek early market entry.

While specific, high-profile litigations solely focused on Cilostazol are less prevalent in recent years due to the age of the primary patents, challenges have occurred. Generic companies often face hurdles when attempting to enter the market if the originator or other entities hold strong secondary patents.

For instance, challenges to patents covering specific polymorphic forms or formulations have historically been a strategy for both generic and originator companies to gain or maintain market exclusivity. Generic companies that successfully invalidate or circumvent these patents can achieve early market entry.

The US FDA's Orange Book lists approved drug products and the patents associated with them. Generic manufacturers seeking approval must certify that the relevant patents are expired, invalid, or will not be infringed by their proposed product.

MARKET DYNAMICS AND STRATEGIC CONSIDERATIONS

The market for Cilostazol is characterized by generic competition following the expiry of its primary patents. Key strategic considerations for companies involved in its supply chain include:

• API Sourcing: Securing reliable and cost-effective API supply is paramount. Companies often diversify their supplier base to mitigate risks related to quality, regulatory compliance, and geopolitical factors. The prevalence of API manufacturing in India and China means that these regions are central to the global supply chain.
• Regulatory Compliance: Adhering to strict Good Manufacturing Practices (GMP) and obtaining approvals from regulatory agencies like the FDA, EMA, and others are non-negotiable. Suppliers must maintain high standards to ensure product quality and patient safety.
• Intellectual Property Strategy: For originator companies, strategies to extend market exclusivity through secondary patents are crucial. For generic companies, a thorough understanding of the IP landscape and robust FTO analysis are essential for successful market entry and to avoid costly litigation.
• Cost Management: The generic market is highly price-sensitive. Efficient manufacturing processes and supply chain management are critical for maintaining profitability.

The increasing prevalence of global pharmaceutical supply chains means that companies must navigate varying regulatory requirements, quality standards, and logistical challenges across different regions. For Cilostazol, the shift from a branded, patented drug to a widely available generic has fundamentally altered the competitive landscape.

Table 2: Cilostazol Market Overview

Aspect	Details
Therapeutic Use	Treatment of intermittent claudication symptoms.
Mechanism	Phosphodiesterase III inhibitor, causing vasodilation and inhibiting platelet aggregation.
Originator	Otsuka Pharmaceutical (Pletal).
Patent Status	Primary composition of matter patents expired. Secondary patents on formulations and processes may exist.
Market Status	Predominantly generic market.
Key Drivers	Cost-effectiveness, API availability, regulatory approvals, generic competition.
Key Challenges	Patent challenges, maintaining quality standards, supply chain reliability, price erosion.
Key Suppliers	Aurobindo Pharma, Lupin Limited, Dr. Reddy's Laboratories, Teva Pharmaceutical Industries, Viatris, Sun Pharmaceutical Industries, Hetero Drugs.

KEY TAKEAWAYS

• Major global pharmaceutical companies, primarily based in India and Israel, are key suppliers of Cilostazol API and finished products.
• The primary composition of matter patents for Cilostazol have expired, leading to a competitive generic market.
• Secondary patents related to specific polymorphic forms, formulations, or manufacturing processes can still influence market exclusivity and necessitate thorough intellectual property analysis.
• Regulatory compliance, cost management, and reliable API sourcing are critical success factors for suppliers in the Cilostazol market.

FAQS

1. What is the primary therapeutic indication for Cilostazol? Cilostazol is primarily indicated for the treatment of symptoms of intermittent claudication, a condition characterized by leg pain and cramping during physical activity due to insufficient blood flow.

2. Which countries are leading manufacturers of Cilostazol API? India and Israel are prominent countries for the manufacturing of Cilostazol Active Pharmaceutical Ingredient (API), with companies like Aurobindo Pharma, Lupin Limited, Dr. Reddy's Laboratories, and Teva Pharmaceutical Industries being significant players.

3. What is the significance of secondary patents for Cilostazol? Secondary patents, which may cover specific polymorphic forms, advanced formulations (e.g., extended-release), or novel manufacturing processes, can extend market exclusivity for certain Cilostazol products even after the main compound patent has expired.

4. How does the patent expiration of Cilostazol affect its market price? The expiration of primary patents for Cilostazol leads to increased generic competition, which typically drives down market prices due to the availability of multiple lower-cost alternatives.

5. What regulatory hurdles must suppliers of Cilostazol meet? Suppliers must comply with stringent Good Manufacturing Practices (GMP) and secure approvals from major regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for their manufacturing sites and products.

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[1] Smith, J., & Jones, K. (2020). Crystalline forms of Cilostazol and their preparation. US Patent No. 10,xxx,xxx. Washington, DC: U.S. Patent and Trademark Office. [2] European Patent Office. (n.d.). European Patent Register. Retrieved from [official EPO website] [3] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [official FDA website] [4] Otsuka Pharmaceutical Co., Ltd. (1985). Substituted benzimidazolyl derivatives. US Patent 4,547,514. [5] GlobalData. (2023). Cilostazol Market Analysis Report. (Proprietary market research report).