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

Suppliers for the Pharmaceutical Drug: Provigil (Modafinil)

Last updated: July 27, 2025

Introduction

Providil, known generically as modafinil, is a wakefulness-promoting agent prescribed primarily for narcolepsy, shift work sleep disorder, and obstructive sleep apnea. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 1998 under the brand name Provigil, the drug has become a significant pharmaceutical product with diverse applications, including off-label uses in cognitive enhancement. As the demand for Provigil grows globally, understanding its supplier landscape is crucial for stakeholders across pharmaceutical, healthcare, and distribution sectors.

Manufacturers and Patent Landscape

The original manufacturer of Provigil was Cephalon, which developed and marketed the drug until its acquisition by Teva Pharmaceutical Industries in 2011. Since then, Teva has maintained a dominant position as a licensee, producing generic versions post-patent expiry in 2012. The patent exclusivity period was a critical determinant for pricing, market entry, and supplier dynamics.

Teva Pharmaceuticals: The Leading Supplier

Teva remains the primary supplier of both branded Provigil and numerous generic formulations. As a global leader in generic pharmaceuticals, Teva's manufacturing facilities are located across multiple countries, including Israel, the United States, and India, providing a robust supply chain that ensures worldwide availability. Their extensive R&D capabilities and manufacturing licenses allow them to produce various formulations, including tablets in multiple dosages (100 mg and 200 mg).

Generic Manufacturers and Market Competition

Following patent expiry, several generic manufacturers entered the Provigil market, increasing supply diversity and reducing prices. Key players include:

• Mylan (Now part of Viatris): A significant generic producer with US and international manufacturing sites.
• Sandoz: Novartis’ generics division offers high-quality modafinil products worldwide.
• Aurobindo Pharma: An Indian manufacturer with a substantial portfolio of CNS drugs.
• Sun Pharmaceutical Industries: India-based manufacturer producing modafinil generics.
• Dr. Reddy’s Laboratories: Prominent in the US and international markets with competitive offerings.

The global presence of these manufacturers ensures a broad supply network that accommodates regional demand variations. Many of these manufacturers source active pharmaceutical ingredients (API) from India or China, where larger API production facilities are based.

API Supply Chain and Raw Material Suppliers

Modafinil’s synthesis hinges on high-quality APIs. The primary API producers for modafinil are predominantly located in China and India, which serve as the backbone of the global supply chain. Companies like Zhejiang NHU Co., Ltd. and ChemSpider are notable API suppliers. The concentration of API production in these regions has led to concerns about supply chain resilience, especially given geopolitical tensions and manufacturing disruptions.

Regulatory Considerations and Market Entry

Suppliers aspiring to enter the Provigil market must navigate complex regulatory pathways, including FDA approval, compliance with Good Manufacturing Practices (GMP), and registration with local health authorities. For generic manufacturers, obtaining FDA ANDA (Abbreviated New Drug Application) approval is vital. For API suppliers, consistent quality certifications (e.g., ISO, cGMP) are prerequisites for integration into the supply chain.

Emerging Trends and Future Supply Dynamics

The increasing off-label use of modafinil as a cognitive enhancer and in treating various neurological disorders is likely to sustain or elevate demand. Additionally, the expiration of patents facilitates more generic manufacturers entering the space, thereby diversifying the supplier base further.

Supply chain risks are a crucial consideration. The COVID-19 pandemic has highlighted vulnerabilities in sourcing APIs from China and India, prompting some companies to explore manufacturing diversification or API stockpiling strategies.

Conclusion

The Provigil supply ecosystem comprises a handful of major pharmaceutical companies, primarily Teva, alongside a competitive pool of generic manufacturers and API suppliers concentrated in Asia. Ensuring a stable, high-quality supply requires collaboration across API producers, pharmaceutical manufacturers, and regulatory bodies. Stakeholders focusing on procurement, market analysis, or investment should monitor patent statuses, regulatory changes, and geopolitical developments impacting supply chains.

---

Key Takeaways

• Major Suppliers: Teva remains the primary manufacturer post-patent expiry, with additional competition from global generic firms like Mylan, Sandoz, and Indian manufacturers.
• API Sources: The global modafinil API supply chain is concentrated in China and India, posing potential risks related to geopolitical tensions or disruptions.
• Market Dynamics: Patent expirations have increased supply options, lowered prices, and created opportunities for new entrants and regional suppliers.
• Regulatory Barriers: Compliance with GMP and approval processes remain significant hurdles for emerging suppliers aiming to enter the Provigil market.
• Supply Chain Resilience: Diversification and strategic stockpiling are increasingly vital amid ongoing geopolitical and pandemic-related supply challenges.

---

FAQs

1. Who are the leading manufacturers of Provigil?
Teva Pharmaceutical Industries is the primary manufacturer of Provigil, especially after acquiring Cephalon. Several generic companies, including Mylan (Viatris), Sandoz, and Indian pharmaceutical firms like Sun Pharma and Dr. Reddy's, produce generic versions following patent expiry.

2. Where does the active pharmaceutical ingredient (API) for modafinil originate?
Most APIs for modafinil are produced in China and India, which supply major API manufacturing facilities. These regions dominate the global API market due to cost efficiencies and capacity.

3. Are there differences in quality among suppliers?
Yes. While regulatory agencies like the FDA require strict GMP compliance, quality can vary among manufacturers. Reputable companies publish rigorous quality certifications, and purchasing from established suppliers mitigates quality risks.

4. How has patent expiration impacted the supplier landscape?
Patent expiry in 2012 significantly increased the number of generic manufacturers, lowering prices, expanding supply options, and encouraging market competition. It also facilitated entry by producers from emerging markets.

5. What risks exist in the Provigil supply chain?
Risks include API shortages due to geopolitical tensions, manufacturing disruptions, regulatory delays, and supply chain vulnerabilities linked to concentrated API production in Asia.

---

Sources

[1] U.S. Food and Drug Administration (FDA). Provigil (Modafinil) Approvals.
[2] Teva Pharmaceutical Industries. Company Overview and Product Portfolio.
[3] Mylan (Viatris). Generic Modafinil Overview.
[4] Novartis Sandoz. Global Generic Product Offerings.
[5] Indian pharmaceutical industry reports, including Sun Pharma, Dr. Reddy’s, and Aurobindo Pharma.
[6] API manufacturers: Zhejiang NHU Co., Ltd., ChemSpider.
[7] Market analyses on generic pharmaceutical market dynamics post-patent expiry.
[8] Supply Chain Risk Reports during COVID-19.