Suppliers and packagers for provigil

provigil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-925-30	30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30)	2012-03-29
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-925-53	60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53)	2012-03-29
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	CIMA LABS INC.	55253-801-30	30 TABLET in 1 BOTTLE (55253-801-30)	2012-03-29
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	CIMA LABS INC.	55253-802-30	30 TABLET in 1 BOTTLE (55253-802-30)	2012-03-29
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	CIMA LABS INC.	55253-802-90	90 TABLET in 1 BOTTLE (55253-802-90)	2012-03-29
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA	Golden State Medical Supply, Inc.	60429-009-30	30 TABLET in 1 BOTTLE (60429-009-30)	1998-12-24
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717	NDA	Golden State Medical Supply, Inc.	60429-010-30	30 TABLET in 1 BOTTLE (60429-010-30)	1998-12-24

Provigil (Modafinil) API Manufacturing and Supply Chain Landscape

Last updated: February 19, 2026

This report analyzes the key suppliers involved in the manufacturing of the active pharmaceutical ingredient (API) for Provigil (modafinil). It identifies major manufacturers, patent expiration timelines, and potential supply chain risks and opportunities. The analysis is critical for R&D investment decisions and procurement strategies within the pharmaceutical industry.

Who Manufactures Modafinil API?

The manufacturing of modafinil API is concentrated among a limited number of global pharmaceutical ingredient suppliers. These entities operate under stringent regulatory oversight and possess the specialized chemical synthesis capabilities required for API production. Key players include both originator companies and generic API manufacturers.

• Cephalon Inc. (a subsidiary of Teva Pharmaceutical Industries Ltd.): As the originator of Provigil, Cephalon, and subsequently Teva, has historically controlled significant manufacturing capacity and intellectual property related to modafinil. Teva continues to be a major producer, particularly for branded and authorized generic versions in key markets.
• Ajanta Pharma Limited: This Indian pharmaceutical company is a significant player in the global generic API market. Ajanta Pharma manufactures modafinil API and supplies it to various finished dosage form manufacturers worldwide. Their involvement is crucial for the availability of generic modafinil.
• Lupin Limited: Another prominent Indian pharmaceutical firm, Lupin Limited, has established capabilities in API manufacturing, including modafinil. They contribute to the global supply chain, supporting generic drug production.
• Sun Pharmaceutical Industries Ltd.: As one of the largest pharmaceutical companies globally, Sun Pharma also participates in the modafinil API market. Their extensive manufacturing network allows for large-scale production.
• Dr. Reddy's Laboratories: This India-based multinational pharmaceutical company is a recognized API manufacturer. Dr. Reddy's supplies modafinil API to support the production of generic modafinil formulations.
• Other Manufacturers: A number of smaller, specialized API manufacturers in countries such as China and India also contribute to the modafinil API supply. These entities often focus on specific steps in the synthesis process or serve regional markets.

The production process for modafinil involves multi-step organic synthesis. Key chemical intermediates and reagents are sourced from various chemical suppliers. The quality and consistency of these raw materials directly impact the purity and efficacy of the final modafinil API. Regulatory compliance, including Good Manufacturing Practices (GMP), is paramount for all API manufacturers to ensure product safety and efficacy.

What are the Key Patents and Expiration Dates for Modafinil?

The patent landscape for modafinil (Provigil) is a critical factor for both innovator and generic companies. The primary patents have expired in major markets, opening opportunities for generic competition.

• U.S. Patent No. 4,177,290: This foundational patent, covering the compound modafinil, was issued on December 4, 1979. Its expiration significantly impacted the exclusivity of Provigil.
• Formulation and Method of Treatment Patents: In addition to the compound patent, Cephalon obtained patents related to specific formulations and methods of treating conditions like narcolepsy. These patents extended market exclusivity. For example, U.S. Patent No. 5,126,359, related to a new crystalline form of modafinil, played a role in extending exclusivity. This patent was a subject of significant litigation.

Key Patent Expiration Timeline (Approximate):

• Core Compound Patent (U.S. 4,177,290): Expired in 2003.
• Secondary Patents (e.g., U.S. 5,126,359): Litigation and extensions led to varied effective expiration dates. Generic entry into the U.S. market began in earnest around 2006-2007 following significant legal challenges that invalidated or circumvented these secondary patents.
• European Patents: Similar to the U.S., key patents in Europe have expired, allowing for generic market entry across member states. Expirations generally aligned with U.S. timelines, with regional variations.
• Other Jurisdictions: Patent expirations in Canada, Australia, and other significant pharmaceutical markets followed similar patterns, with specific dates varying based on local patent laws and grant dates.

The expiration of these patents has led to a highly competitive generic market. Generic manufacturers can now legally produce and sell modafinil, provided they meet regulatory requirements and do not infringe on any remaining valid, unexpired patents (though these are now minimal for the core API).

What are the Regulatory Considerations for Modafinil API Suppliers?

Suppliers of modafinil API must adhere to a comprehensive set of regulatory requirements to ensure the quality, safety, and efficacy of their products. These regulations are enforced by health authorities worldwide.

• Good Manufacturing Practices (GMP): All facilities manufacturing modafinil API must comply with current GMP guidelines. This includes:
  • Quality Management Systems: Robust systems for quality control, assurance, and documentation.
  • Process Validation: Ensuring that the manufacturing process consistently produces API meeting predefined specifications.
  • Facility and Equipment Qualification: Maintaining suitable infrastructure and validated equipment.
  • Personnel Training: Ensuring that all personnel involved in manufacturing are adequately trained.
  • Record Keeping: Maintaining detailed records of all manufacturing activities, raw material sourcing, and testing.
  • Change Control: Managing any changes to the manufacturing process, materials, or equipment to prevent adverse impacts on quality.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies like the U.S. Food and Drug Administration (FDA). A DMF contains confidential detailed information about facilities, processes, and materials used in the manufacturing of the API. Finished drug product manufacturers can then reference these DMFs in their marketing applications.
• Inspections and Audits: API manufacturing sites are subject to regular inspections by regulatory authorities (e.g., FDA, European Medicines Agency (EMA), national competent authorities). Pharmaceutical companies also conduct audits of their API suppliers to ensure compliance and quality.
• Impurity Profiling: Manufacturers must accurately identify and control impurities in the API. Regulatory guidelines set limits for known and unknown impurities. The synthesis route and control of critical steps are vital for managing impurity profiles.
• Stability Studies: API suppliers must conduct stability studies to determine the shelf-life of the API under various storage conditions, ensuring its quality over time.
• Supply Chain Security and Traceability: Regulations increasingly emphasize the security and traceability of the pharmaceutical supply chain to prevent counterfeiting and ensure product integrity.
• Controlled Substance Status: While modafinil is not typically classified as a controlled substance in the same manner as amphetamines, its stimulant-like properties mean that its distribution and prescribing are often monitored. API suppliers must be aware of any specific national or international regulations related to its handling and trade.

Compliance with these regulations is non-negotiable. Failure to meet these standards can result in product recalls, import alerts, warning letters, and ultimately, loss of market access.

How Does the Modafinil API Supply Chain Present Risks and Opportunities?

The global supply chain for modafinil API, characterized by patent expirations and a concentrated manufacturer base, presents both significant risks and strategic opportunities.

Risks:

• Supply Disruptions:
  • Geopolitical Instability: Reliance on API manufacturers in specific regions can expose the supply chain to geopolitical risks, trade disputes, or national export restrictions.
  • Natural Disasters and Pandemics: Events like earthquakes, floods, or global health crises can disrupt manufacturing operations and logistics. The COVID-19 pandemic highlighted the vulnerabilities in global pharmaceutical supply chains.
  • Quality Compliance Issues: A single API manufacturer facing regulatory action (e.g., FDA warning letter, import ban) due to quality deviations can lead to a sudden shortage for multiple finished drug product manufacturers relying on that supplier.
  • Raw Material Shortages: Disruptions in the supply of key chemical intermediates or raw materials required for modafinil synthesis can halt API production.
• Price Volatility:
  • Limited Supplier Base: A concentrated number of API suppliers can lead to less competitive pricing, especially if demand outstrips supply.
  • Increased Regulatory Costs: Escalating compliance costs for API manufacturers can be passed on to customers.
  • Currency Fluctuations: For globally traded APIs, currency exchange rate volatility can impact costs.
• Intellectual Property and Litigation Risks:
  • Patent Litigation: Although the primary patents have expired, ongoing litigation concerning manufacturing processes, polymorphs, or specific impurities can still create uncertainty for some suppliers or generic products.
  • Counterfeiting and Substandard APIs: The global nature of API sourcing increases the risk of counterfeit or substandard products entering the supply chain, posing significant risks to patient safety and brand reputation.
• Quality Control Challenges:
  • Auditing Complexity: Ensuring consistent quality across multiple suppliers, potentially located in different regulatory environments, requires robust auditing and oversight.
  • Impurity Control: Variations in synthesis routes or raw material quality can lead to different impurity profiles, requiring vigilant monitoring and characterization.

Opportunities:

• Market Expansion for Generic Manufacturers:
  • Increased Accessibility: The availability of affordable generic modafinil API allows generic drug manufacturers to expand their market reach and offer cost-effective treatments to a wider patient population.
  • New Market Entry: Expired patents enable new generic companies to enter markets previously dominated by the innovator product.
• Strategic Sourcing and Diversification:
  • Dual/Multi-Sourcing: Companies can mitigate supply risk by establishing relationships with multiple qualified API suppliers across different geographic regions. This enhances resilience against single-point failures.
  • Backward Integration: Some larger pharmaceutical companies might consider backward integration, bringing API manufacturing in-house or establishing strategic partnerships to secure supply.
• Process Innovation and Efficiency:
  • Cost Reduction: Generic API manufacturers continually seek to optimize synthesis routes, improve yields, and reduce manufacturing costs through process innovation. This can lead to more competitive API pricing.
  • Green Chemistry: Opportunities exist for developing more environmentally sustainable synthesis pathways for modafinil API.
• Emerging Market Opportunities:
  • Untapped Demand: As healthcare access and affordability improve in emerging economies, the demand for essential medicines like modafinil is expected to grow. API suppliers with competitive pricing and compliant manufacturing can capitalize on these markets.
• Specialized Manufacturing Capabilities:
  • Contract Manufacturing Organizations (CMOs): CMOs with specialized expertise in complex organic synthesis and stringent quality control can offer valuable services to companies lacking in-house API manufacturing capabilities.

Key Takeaways

The modafinil API manufacturing landscape is characterized by the expiry of foundational patents, leading to a competitive generic market. Key suppliers are primarily located in India and, to a lesser extent, the U.S. and Europe. Regulatory compliance, particularly GMP standards and DMF submissions, is critical for all manufacturers. Supply chain risks stem from geopolitical factors, quality control challenges, and potential disruptions. Opportunities lie in market expansion for generics, strategic diversification of sourcing, and process innovation to drive cost efficiencies and sustainability.

Frequently Asked Questions

1. Are there any remaining patents that could impact modafinil API production? While primary compound patents have expired, there could be patents on specific crystalline forms, manufacturing processes, or impurity profiles. These are typically challenged during generic drug approval processes.

2. What is the typical purity standard for modafinil API? Modafinil API is expected to meet strict purity standards, typically above 98.5% or 99.0% as per pharmacopoeial monographs (e.g., USP, EP, JP). Specific limits apply to known and unknown impurities.

3. How does the FDA regulate modafinil API imports? The FDA requires imported APIs to be manufactured in compliance with U.S. GMP standards. Manufacturers often submit Drug Master Files (DMFs) that the FDA reviews as part of finished drug product applications. The FDA also conducts inspections of foreign manufacturing facilities.

4. What are the main chemical precursors used in modafinil synthesis? Common precursors can include chemicals like diphenylmethyl sulfide, acetic anhydride, and various oxidizing agents. The specific synthesis route can vary between manufacturers.

5. Can a single API supplier experience a manufacturing halt that affects the entire market? Yes, if a dominant or sole supplier for a particular region or for multiple generic manufacturers experiences a significant quality issue leading to a shutdown or import alert, it can create widespread API shortages for finished drug products.

Citations

[1] U.S. Patent and Trademark Office. (1979). U.S. Patent No. 4,177,290. Retrieved from USPTO Patent Center. [2] U.S. Patent and Trademark Office. (1992). U.S. Patent No. 5,126,359. Retrieved from USPTO Patent Center. [3] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from FDA website. [4] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP). Retrieved from FDA website.