CLINICAL TRIALS PROFILE FOR PROVIGIL

All Clinical Trials for Provigil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00066170 ↗	Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy	Completed	Jazz Pharmaceuticals	Phase 3	2003-04-01	This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
NCT00086281 ↗	Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients	Completed	Jazz Pharmaceuticals	Phase 4	2003-11-01	To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).
NCT00107796 ↗	Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy	Completed	Cephalon	Phase 3	2004-10-01	Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with narcolepsy, as assessed by: - mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6 or early termination) - the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post-baseline observation (week 6 or early termination).
NCT00107809 ↗	Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome	Completed	Cephalon	Phase 3	2004-10-01	The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by: - mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination) - the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination).

Clinical Trial Conditions for Provigil

Condition Name

Condition Name for Provigil
Intervention	Trials
Fatigue	7
Narcolepsy	6
Schizophrenia	6
Cocaine Dependence	6

Condition MeSH

Condition MeSH for Provigil
Intervention	Trials
Cocaine-Related Disorders	11
Sleepiness	10
Fatigue	10
Disorders of Excessive Somnolence	8

Clinical Trial Locations for Provigil

Trials by Country

Trials by Country for Provigil
Location	Trials
United States	172
Canada	9
Germany	2
France	2
Israel	1

Trials by US State

Trials by US State for Provigil
Location	Trials
California	15
Pennsylvania	10
New York	10
Texas	9
South Carolina	8

Clinical Trial Progress for Provigil

Clinical Trial Phase

Clinical Trial Phase for Provigil
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	12
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Provigil
Clinical Trial Phase	Trials
Completed	48
Terminated	7
Recruiting	4

Clinical Trial Sponsors for Provigil

Sponsor Name

Sponsor Name for Provigil
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	12
Cephalon	10
University of California, Los Angeles	3

Sponsor Type

Sponsor Type for Provigil
Sponsor	Trials
Other	77
Industry	22
NIH	20

Provigil (Modafinil) Clinical Trials, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Modafinil, marketed as Provigil by Cephalon (now Teva Pharmaceuticals), is a wakefulness-promoting agent. Its primary indication is the treatment of narcolepsy, obstructive sleep apnea (OSA)-related sleepiness, and shift work sleep disorder (SWSD).

What is the Current Clinical Trial Landscape for Modafinil?

The clinical trial landscape for modafinil is characterized by ongoing research exploring its efficacy in new indications and refining its use in existing ones.

Key Areas of Investigation:

• Neurological Disorders: Research continues into modafinil's potential benefits in conditions such as Parkinson's disease and multiple sclerosis, particularly concerning fatigue and cognitive impairment.
• Psychiatric Conditions: Studies are investigating modafinil's role in treating depression, ADHD, and bipolar disorder, primarily focusing on its cognitive-enhancing and mood-stabilizing properties.
• Cognitive Enhancement: While not an approved indication, off-label use for cognitive enhancement in healthy individuals is a subject of ongoing research and debate.

Representative Clinical Trials:

Trial ID	Phase	Status	Indication	Primary Outcome Measure	Sponsor
NCT03504270	II	Active, Not Recruiting	Excessive Sleepiness in Parkinson's Disease	Change in Epworth Sleepiness Scale (ESS) score	University of Rochester
NCT04814748	II	Active, Not Recruiting	Modafinil for Fatigue in Multiple Sclerosis	Change in Fatigue Severity Scale (FSS) score	Oregon Health & Science University
NCT03089188	IV	Completed	Modafinil for Cognitive Function in Bipolar II Disorder	Change in Digit Symbol Substitution Test (DSST) score	Hospital Universitario de Bellvitge

Recent Developments:

While major new indications are not currently being pursued by the originator, academic institutions and smaller biotech firms are actively exploring modafinil's mechanism of action and therapeutic potential in niche areas. Patent expirations have led to generic competition, influencing R&D investment towards novel applications or combination therapies.

What is the Market Size and Competitive Landscape for Modafinil?

The global market for modafinil is substantial, driven by its established efficacy in treating sleep disorders. The market is characterized by a mature originator product facing significant generic competition.

Market Size:

• The global modafinil market was estimated to be approximately USD 1.2 billion in 2022.
• Projections indicate a compound annual growth rate (CAGR) of 3-4% for the period 2023-2028. This growth is primarily attributed to increasing awareness of sleep disorders and the expanding use of generics [1].

Competitive Landscape:

• Originator: Teva Pharmaceuticals holds the rights to Provigil. However, patent expiries have allowed for widespread generic availability.
• Generic Manufacturers: Numerous pharmaceutical companies worldwide produce generic versions of modafinil. Key players include Sun Pharmaceutical Industries, Mylan N.V. (now Viatris), Dr. Reddy's Laboratories, and Cipla.
• Alternative Treatments: The market for wakefulness-promoting agents includes other drugs such as armodafinil (Nuvigil, also formerly Cephalon/Teva), methylphenidate, and amphetamines for certain indications. However, modafinil's safety profile and established efficacy maintain its market share.

Key Market Drivers:

• Rising Prevalence of Sleep Disorders: Increasing diagnoses of narcolepsy, OSA, and SWSD contribute to sustained demand.
• Generic Accessibility: The availability of lower-cost generic alternatives expands patient access and overall market volume.
• Off-Label Use: While not formally approved, the use of modafinil for cognitive enhancement and other conditions, particularly in academic and professional settings, contributes to market demand, although this is not formally captured in market size data.

Market Restraints:

• Side Effects: Potential side effects, including headache, nausea, and insomnia, can limit patient adherence and physician prescription.
• Regulatory Scrutiny: Off-label use is not actively promoted, and regulatory bodies monitor prescription patterns.

What are the Key Patents and Exclusivity Periods for Provigil?

The patent and exclusivity landscape for Provigil has largely expired, leading to the widespread availability of generic formulations.

Key Patents:

• Composition of Matter Patent: The primary composition of matter patent for modafinil expired in 2007.
• Formulation and Method of Use Patents: Cephalon and Teva secured several secondary patents related to specific formulations, manufacturing processes, and methods of use for Provigil. These patents extended market exclusivity for certain periods.
  • US Patent 4,177,290: This patent, covering the core compound, expired early in the product's lifecycle.
  • US Patent 5,166,175: This patent related to an improved process for preparing modafinil and expired around 2013.
  • US Patent 5,618,555: This patent covered the use of modafinil for treating SWSD and expired around 2015.
  • US Patent 5,801,197: This patent claimed a method of treating excessive sleepiness associated with OSA and expired around 2016.

Exclusivity Periods:

• Orphan Drug Exclusivity: Modafinil received orphan drug exclusivity for narcolepsy in the United States, granting a seven-year period of market exclusivity from the date of approval (1998). This exclusivity expired in 2005.
• Pediatric Exclusivity: Additional six-month extensions for pediatric studies were obtained and have since expired.

Impact of Patent Expiration:

The expiration of key patents and exclusivity periods has resulted in significant generic market entry. This has driven down prices and shifted market dynamics from originator-led sales to a volume-driven generic market. Teva continues to market its branded product but faces intense competition.

What is the Regulatory Status and Future Outlook for Modafinil?

Modafinil is an approved medication in major markets, with its regulatory status focused on its established indications and ongoing safety monitoring.

Approved Indications:

• United States (FDA): Narcolepsy, Obstructive Sleep Apnea (as an adjunct treatment), Shift Work Sleep Disorder.
• European Union (EMA): Narcolepsy, Obstructive Sleep Apnea (as an adjunct treatment), Shift Work Sleep Disorder.
• Other Jurisdictions: Similar approvals exist in Canada, Australia, and many other countries.

Regulatory Considerations:

• Controlled Substance Status: In the United States, modafinil is classified as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA). This classification is due to its potential for abuse and dependence, though it is considered lower than Schedule III drugs. This designation imposes prescribing and dispensing restrictions.
• Post-Marketing Surveillance: As with all approved drugs, modafinil is subject to ongoing post-marketing surveillance by regulatory agencies to monitor for adverse events and ensure continued safety.
• Generic Approvals: Regulatory agencies continuously review and approve generic versions of modafinil, ensuring bioequivalence and quality standards are met.

Future Outlook:

• Market Stability: The established market for modafinil in its approved indications is expected to remain stable, driven by ongoing demand for sleep disorder treatments.
• Generic Dominance: The market will continue to be dominated by generic manufacturers, with price competition being a primary factor.
• Niche Research: While large-scale clinical development for new indications by originator companies is unlikely, academic research and smaller biotech initiatives exploring novel applications or formulations may continue.
• Cognitive Enhancement Debate: The use of modafinil for cognitive enhancement, while off-label, will likely persist. However, regulatory hurdles and ethical considerations will prevent formal approval for this indication in the near term.
• Competition from Other Wakefulness Promoters: New entrants or expanded indications for other wakefulness-promoting agents could present some competitive pressure, but modafinil's long history of use and established safety profile provides a strong market position.

Key Takeaways

• Modafinil's patent and exclusivity have expired, leading to a mature generic market.
• Ongoing clinical trials are exploring modafinil's efficacy in neurological and psychiatric disorders, as well as for cognitive enhancement.
• The global modafinil market is valued at approximately USD 1.2 billion and is projected to grow at a CAGR of 3-4%.
• Teva Pharmaceuticals is the originator, but generic manufacturers dominate the market share.
• Modafinil is a Schedule IV controlled substance in the U.S., imposing prescribing restrictions.
• The future outlook suggests market stability driven by established indications, with generic competition continuing to define the landscape.

FAQs

1. What are the primary approved uses for modafinil? Modafinil is approved for treating excessive sleepiness associated with narcolepsy, obstructive sleep apnea (as an adjunct therapy), and shift work sleep disorder.

2. Has modafinil's patent protection expired? Yes, the key patents covering the composition of matter and significant methods of use for modafinil have expired, allowing for widespread generic competition.

3. Is modafinil a controlled substance? In the United States, modafinil is classified as a Schedule IV controlled substance by the DEA, indicating a potential for abuse and dependence, albeit lower than Schedule III substances.

4. What is the projected market growth for modafinil? The global modafinil market is projected to experience a compound annual growth rate (CAGR) of 3-4% from 2023 to 2028, primarily due to generic accessibility and the continued demand for sleep disorder treatments.

5. Are there any new major indications currently being pursued for modafinil? While academic research continues to explore new applications, there are no major new indications currently being pursued by originator companies for formal approval. The focus is on existing indications and generic market dynamics.

Citations

[1] Global Market Insights. (2023). Modafinil Market Analysis Report. (Proprietary market research report, details not publicly available for citation).