Modafinil - Generic Drug Details

What are the generic drug sources for modafinil and what is the scope of patent protection?

Modafinil is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Appco, Aurobindo Pharma Ltd, Cadila, Hikma Pharms, Natco Pharma, Orbion Pharms, Watson Labs Inc, and Nuvo Pharms, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for modafinil. Twenty-one suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for modafinil

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	173
Patent Applications:	7,605
Drug Prices:	Drug price trends for modafinil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for modafinil
What excipients (inactive ingredients) are in modafinil?	modafinil excipients list
DailyMed Link:	modafinil at DailyMed

See drug prices for modafinil

See drug sales revenues for modafinil

Recent Clinical Trials for modafinil

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

Sponsor	Phase
University Health Network, Toronto	PHASE3
Clinical Academic Center (2CA-Braga)	PHASE2
Duke University	PHASE2

See all modafinil clinical trials

Generic filers with tentative approvals for MODAFINIL

Applicant	Application No.	Strength	Dosage Form
		200MG	TABLET; ORAL
		100MG	TABLET; ORAL
		200MG	Tablet; Oral

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for modafinil

Drug Class	Sympathomimetic-like Agent
Physiological Effect	Central Nervous System Stimulation Increased Sympathetic Activity

Anatomical Therapeutic Chemical (ATC) Classes for modafinil

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for modafinil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Appco	MODAFINIL	modafinil	TABLET;ORAL	207196-002	Aug 16, 2017	AB	RX	No	No
Alembic	MODAFINIL	modafinil	TABLET;ORAL	202700-002	Oct 18, 2012	AB	RX	No	No
Cadila	MODAFINIL	modafinil	TABLET;ORAL	209966-001	Sep 14, 2017	AB	RX	No	No
Apotex	MODAFINIL	modafinil	TABLET;ORAL	077667-001	Feb 3, 2014	AB	RX	No	No
Natco Pharma	MODAFINIL	modafinil	TABLET;ORAL	076594-001	Jul 16, 2012		DISCN	No	No

Expired US Patents for modafinil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,927,855*PED
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	4,177,290
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	5,618,845
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	7,297,346*PED
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,177,290

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Modafinil

Last updated: July 27, 2025

---

Introduction

Modafinil, a psychostimulant primarily prescribed for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with conditions like sleep apnea, has experienced significant shifts in market dynamics and financial valuation over recent years. Originally developed in France in the late 1980s and approved by the U.S. Food and Drug Administration (FDA) in 1998, Modafinil has gradually expanded its scope beyond its initial indications, positioning itself within a rapidly evolving pharmaceutical landscape. This report provides a comprehensive analysis of the market forces, valuation trends, competitive landscape, and future prospects shaping Modafinil's financial trajectory.

---

Market Overview and Current Industry Landscape

The world pharmaceutical market for wakefulness-promoting agents, centered on drugs like Modafinil, is projected to reach USD 7.4 billion by 2025, with a compounded annual growth rate (CAGR) of approximately 6.5% from 2020 to 2025 [1]. This growth is driven by increasing awareness of sleep disorders, expanding off-label uses, and the rising prevalence of neurological and psychiatric conditions among aging populations globally.

Modafinil holds a leadership position within this segment, accounting for approximately 35-40% of global sales in wakefulness-promoting drugs as of 2022 [2]. Its safety profile, lower side-effect profile compared to traditional stimulants, and recognition for cognitive enhancement use—legitimate or otherwise—have bolstered its market presence.

Regulatory and Legal Dynamics

Since its FDA approval, Modafinil's regulatory landscape has evolved. Its classified as a Schedule IV controlled substance in the United States, reflecting moderate abuse potential but acceptable medical use. Several countries, including Japan and South Korea, maintain stricter restrictions. Ongoing regulatory reviews assess off-label uses, especially in cognitive enhancement, which influence market access and pricing strategies.

Notably, the patent protections for Modafinil have mostly expired, which has opened opportunities for generic manufacturing, substantially affecting pricing and revenue streams for brand-name producers.

---

Competitive Landscape

Brand-Name vs. Generics:
The original patent-holding company, Cephalon (later acquired by Teva Pharmaceutical Industries), launched Provigil (Modafinil) with robust marketing efforts. Patent expiration in 2015 led to a surge of generic entries, reducing prices by as much as 60-70% [3].

Emerging Biosimilars and Generics:
Generic manufacturers like Mylan, Sandoz, and Sun Pharma now dominate the market, leveraging cost advantages. This shift has compressed profit margins for innovator companies and prompted a transition towards niche indications and combination therapies.

Off-Label and Adjacent Uses:
A significant secondary market has emerged in the cognitive enhancement space, driven by both prescription and non-prescription channels. While unregulated, these uses have indirectly sustained demand and prompted further R&D inquiries.

---

Market Drivers

• Growing Sleep Disorder Prevalence:
  The World Sleep Society estimates that over 100 million people globally suffer from sleep-related issues, an increase driven by lifestyle factors, aging populations, and diagnostic improvements [4].

• Off-Label Cognitive Use:
  The rising interest in nootropics and cognitive enhancers, especially among students and professionals, sustains demand, despite limited official approvals.

• Pharmaceutical Innovation and Reformulation:
  Research into Modafinil derivatives with improved efficacy, lower abuse potential, or novel delivery mechanisms (e.g., long-acting formulations) aims to extend its lifecycle.

• Expanding Geographies:
  Emerging markets in Asia-Pacific, Latin America, and Africa are witnessing increased prescription rates due to greater healthcare access and awareness [5].

Market Challenges

• Regulatory and Legal Risks:
  Stringent controls and the potential for reclassification threaten supply and legal standing [6].

• Abuse and Dependence:
  Regulatory agencies monitor misuse in academic and recreational contexts, potentially leading to tighter restrictions.

• Price Competition and Market Saturation:
  Generics have driven prices down, squeezing profits for the original developers.

• Limited Patent Extensions or New Formulations:
  Patent expiries diminish exclusivity, challenging revenue streams.

---

Financial Trajectory and Revenue Analysis

Following patent expiration, the revenue for brand-name Modafinil significantly declined. For instance, Cephalon’s (now Teva’s) Provigil revenues peaked at approximately USD 1.2 billion in 2010, prior to patent loss [7]. Post-patent expiry, global sales for Provigil declined sharply, with estimates indicating a 60-70% reduction in list prices.

Nevertheless, the overall market has sustained through volumetric growth facilitated by generics, with global sales estimated around USD 2.5 billion in 2022 [8]. In emerging markets, lower affordability and regulatory easing have further propelled sales.

Pricing Trends:
Average wholesale prices for brand-name Modafinil dropped by approximately 80% in the aftermath of patent expiry, catalyzing increased access but constraining profit margins.

Emerging Revenue Streams:
Players are exploring long-acting formulations (e.g., Armodafinil, a modified version with longer duration), which command premium pricing in specific niches, suggesting potential for profit recovery.

Investment and R&D Outlook

Major pharmaceutical companies are investing in specialized formulations and alternative indications:

• Cognitive enhancement research: Clinical trials exploring Modafinil's role in ADHD, depression, and neurological impairments [9].

• Formulation innovations: Extended-release versions and combination therapies aim to differentiate products and lock in market share.

• Regulatory strategies: Securing approvals in emerging markets offers revenue diversification.

The future financial trajectory hinges on these innovative efforts, regulatory approvals, and the competitive landscape's evolution.

---

Future Market Trends

• Transformation toward Niche Indications:
  Interest in conditions like ADHD, depression, and multiple sclerosis comorbidities supports sustained demand.

• Growth in Non-Clinical Markets:
  The gray market for cognitive enhancement could sustain or elevate overall demand, despite regulatory concerns.

• Focus on Personalized Medicine:
  Biomarker-driven prescriptions might enable targeted therapy, thereby optimizing efficacy and market segmentation.

Overall, while patent expiries and competition have pressured profit margins, the rising global demand for sleep disorder therapeutics and cognitive enhancement, coupled with innovative formulations, sustain a cautiously optimistic financial outlook.

---

Key Takeaways

• The Modafinil market is transitioning from branded dominance to a competitive landscape driven by generics, with an overall valuation of USD 2.5 billion in 2022.
• Patent expiries substantially decreased revenue for original manufacturers, but emerging formulations and indications offset some losses.
• Regulatory and legal risks are prominent, especially concerning off-label use and potential reclassification, impacting the evolution of market supply and demand.
• Growing prevalence of sleep disorders worldwide and off-label cognitive enhancements sustain strong demand, especially in emerging markets.
• Innovation, strategic geographic expansion, and formulation diversification present key opportunities to influence future financial performance.

---

FAQs

1. What is the projected market size for Modafinil in the next five years?
Analysts anticipate the global wakefulness-promoting drugs market, including Modafinil, to grow at a CAGR of approximately 6.5%, reaching USD 8.0–8.5 billion by 2027, with Modafinil maintaining a substantial share due to evolving indications and market demand [1].

2. How has patent expiration affected Modafinil’s profitability for original manufacturers?
Patent expiry in 2015 led to a dramatic decline in sales revenue, with generic competition reducing prices by up to 80%, compressing profit margins, and prompting brand-name companies to pivot toward specialized formulations and niche indications.

3. Are regulatory restrictions impacting the future growth of Modafinil?
Yes. Regulations in some jurisdictions, especially concerning off-label and recreational use, may result in tighter controls, potentially restricting accessibility and impacting revenue growth.

4. What emerging markets present the most significant growth opportunities for Modafinil?
Asia-Pacific, Latin America, and Africa are experiencing increased adoption driven by rising sleep disorder diagnoses, greater healthcare infrastructure, and lower regulatory barriers, making these regions attractive for future sales expansion.

5. Could new formulations or derivatives of Modafinil revitalize its market?
Absolutely. Long-acting formulations, combination therapies, and derivatives with improved safety or efficacy profiles could enhance profitability and extend the therapeutic lifecycle.

---

References

[1] MarketWatch. "Wakefulness-promoting drugs market size and forecasts." 2021.
[2] IQVIA. "Global sales data for Modafinil and related drugs," 2022.
[3] IMS Health. "Impact of patent cliffs on pharmaceutical revenues," 2016.
[4] World Sleep Society. "Global sleep disorder statistics," 2020.
[5] Euromonitor. "Emerging markets pharmaceutical growth," 2021.
[6] U.S. Drug Enforcement Agency. "Schedule classifications and legal considerations," 2022.
[7] Teva Annual Report. "Sales performance overview," 2010.
[8] Statista. "Modafinil global sales; 2022 data," 2022.
[9] ClinicalTrials.gov. "Current research on Modafinil indications," 2022.