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
		100MG	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
Orbion Pharms	MODAFINIL	modafinil	TABLET;ORAL	078963-001	Sep 26, 2012	AB	RX	No	No
Alembic	MODAFINIL	modafinil	TABLET;ORAL	202700-002	Oct 18, 2012	AB	RX	No	No
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	AB	RX	Yes	No
Natco Pharma	MODAFINIL	modafinil	TABLET;ORAL	076594-002	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	RE37516*PED
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,177,290
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	5,618,845

Market Dynamics and Financial Trajectory for Modafinil: An In-Depth Analysis

Last updated: December 20, 2025

Executive Summary

Modafinil (brand names include Provigil and Alertec) is a wakefulness-promoting agent indicated primarily for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with conditions such as ADHD and obstructive sleep apnea. Over the past decade, the global market for Modafinil has experienced significant developments driven by shifting regulatory landscapes, expanding therapeutic indications, and increasing off-label use.

This analysis provides a comprehensive overview of the market and financial trajectory for Modafinil, including current demand, growth drivers, competitive landscape, regulatory challenges, and future outlook. Emphasis is placed on recent patent expirations, market entrants, pricing trends, and key industry players shaping the landscape.

Market Overview

Aspect	Detail
Global Market Size (2022)	Estimated at USD 1.2 billion with a compound annual growth rate (CAGR) of 6.2% expected through 2030 [1].
Key Markets	United States, Europe, Japan, China, emerging markets in Asia and Latin America.
Major Manufacturers	Cephalon (acquired by Teva), Sun Pharma, Mylan, Luiten, and generic drugmakers.
Therapeutic Use	Narcolepsy (~43%), shift work disorder (~17%), ADHD (~12%), off-label cognitive enhancement (~28%).

Market Drivers

1. Expanding Approved Indications

Modafinil's original FDA approval in 1998 has been extended to multiple indications, broadening its market potential. For example, off-label use for cognitive enhancement in healthy individuals is a significant, though unregulated, driver.

2. Patent Expiry and Generics Entry

Patent expiration in key markets (U.S. in 2013, EU in 2014) prompted a surge in generic competition, reducing prices but increasing volume-driven revenue streams for manufacturers.

3. Growing Awareness of Sleep Disorders

Incidence of sleep disorders is rising globally, fueled by lifestyle changes, increasing obesity, and aging populations, bolstering demand.

4. Regulatory Approvals & Off-Label Demand

Increased off-label prescriptions for cognitive and military purposes; the U.S. military, for example, has evaluated Modafinil for operational alertness.

5. Ethical and Legal Concerns

Off-label use and potential abuse have prompted regulatory scrutiny, influencing market dynamics.

Competitive Landscape

Market Share Distribution (2022)

Company	Market Share	Notes
Teva (via Cephalon)	~45%	Leader pre- and post-patent expiration; dominant in generic segment.
Sun Pharma	~10%	Notable for aggressive pricing and broad distribution.
Mylan	~8%	Focused on generic formulations, especially in Europe.
Other Generics	~25%	Includes local manufacturers in Asia and Latin America.
Innovator Brands	~12%	Small but strategic segment targeting niche indications.

Note: Market shares are estimations based on global sales data and patent statuses.

Pricing Trends

Timeframe	Price (USD per tablet)	Notes
2010	$4.00 - $6.00	Patent-protected era; limited generics.
2014	$1.50 - $3.00	Post-patent expiry; increased generic competition.
2022	$0.50 - $1.50	Market saturation and volume growth.

Regulatory Landscape

Region	Status	Implications
United States	FDA-approved; FDA enforces strict off-label use controls	Patent expiration led to generics; off-label use remains prevalent.
European Union	EMA-approved; national agencies regulate off-label use	Similar patent and regulatory status as US; stricter control.
Asia (China, Japan)	Regulations vary; increasing acceptance	Growing market; potential for regulatory hurdles on imports.
Legal & Ethical Issues	Concerns about misuse, military use, and cognitive enhancement	Potential for regulatory tightening affecting market growth.

Financial Trajectory and Revenue Projections

Year	Estimated Global Revenue (USD billions)	Notes
2022	1.2	Peak revenue post-patent expiry driven by generics.
2025	1.4	Expected increase due to expanding indications and off-label use.
2030	1.7	Market maturation; driven by new formulations and emerging markets.

Revenue Breakdown by Region (2022)

Region	Percentage of Total Revenue	Key Factors
North America	52%	Largest market, high off-label usage, patent expiries.
Europe	25%	Mature market, high acceptance and regulatory control.
Asia-Pacific	15%	Growth potential, increasing awareness, and manufacturing hubs.
Rest of World	8%	Emerging markets with growing sleep disorder prevalence.

Emerging Trends and Innovations

Novel Formulations

• Extended-Release (XR) formulations: Increasing availability enhances compliance.
• Combination Therapies: Combining Modafinil with other CNS drugs to target comorbidities.

Digital Health Integration

• Digital adherence devices and monitoring apps improve patient compliance, impacting revenue consistency.

Market Expansion through Off-Label Uses

• Cognitive enhancement remains unregulated but lucrative, especially in academic and military sectors.

Challenges Facing the Modafinil Market

Challenge	Impact	Mitigation Strategies
Regulatory Scrutiny	Potential restrictions on off-label use	Engage policymakers, reinforce clinical value.
Generic Competition	Price erosion	Focus on differentiated formulations and niche markets.
Potential Abuse and Dependence	Regulatory restrictions, reputation risk	Implement strict prescribing guidelines.
Intellectual Property & Patent Litigation	Delays in market expansion	Patent strategies, licensing agreements.

Comparison: Modafinil vs. Related Wakefulness Agents

Attribute	Modafinil	Armodafinil	Traditional Stimulants (e.g., Amphetamines)
Approval Indications	Narcolepsy, shift work disorder	Same as Modafinil	Narcolepsy, ADHD
Schedule (US)	Not scheduled (FDA approved)	Not scheduled	Schedule II
Side Effect Profile	Fewer cardiovascular issues, lower abuse potential	Similar	Higher abuse potential, cardiovascular risks
Cost	Lower post-generic	Slightly higher	Varies, often higher

Future Outlook and Investment Opportunities

Opportunity	Rationale	Risks
Emerging Markets	Increasing sleep disorder prevalence	Regulatory barriers, market entry costs
Novel Drug Delivery	Improved compliance, reduced misuse	R&D costs, delayed ROI
Off-Label Cognitive Markets	Untapped high-margin sector	Ethical and legal challenges
Partnerships & Licensing	Broader access and market penetration	Competitive dynamics, regulatory delays

Conclusion

Modafinil's market is characterized by a mature core with expanding peripheral opportunities. While patent expiry and generic competition have depressed prices, increased utilization for established and emerging indications sustains revenue growth. Regulatory oversight and ethical considerations remain critical factors influencing its trajectory.

Key Takeaways

• The global Modafinil market was approximately USD 1.2 billion in 2022, with projections reaching USD 1.7 billion by 2030.
• Patents protection ended in major markets between 2013-2014, encouraging generic proliferation.
• Demand continues to grow due to rising sleep disorder prevalence and off-label use for cognitive enhancement.
• Regulatory scrutiny on off-label use and abuse potential could impact future growth.
• Opportunities exist in emerging markets, novel formulations, and digital health integrations.
• Strategic positioning around niche indications and geopolitical considerations will define market leaders.

FAQs

1. What are the primary therapeutic indications for Modafinil?
Modafinil is primarily prescribed for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with conditions like obstructive sleep apnea and ADHD.

2. How has patent expiration affected Modafinil's market dynamics?
Patent expirations in 2013-2014 led to a surge in generic manufacturing, significantly reducing prices but increasing market volume, thus maintaining overall revenue streams.

3. What are the key challenges facing Modafinil manufacturers?
Regulatory scrutiny, potential restrictions on off-label use, abuse risks, and intense generic competition are foremost challenges impacting profit margins and growth.

4. Which regions present the highest growth opportunities?
Emerging markets in Asia-Pacific and Latin America, driven by increasing sleep disorder prevalence and regulatory enhancements, offer significant growth potential.

5. What future innovations could impact the Modafinil market?
Extended-release formulations, combination therapies, digital adherence tools, and formulations targeting new indications could redefine market dynamics.

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References

[1] Market Research Future. “Global Modafinil Market Overview,” 2022.
[2] IQVIA Data, "Pharmaceutical Sales Analysis," 2022.
[3] U.S. Food and Drug Administration. “FDA Approval Notices,” 1998, 2013.
[4] European Medicines Agency. “Summary of Product Characteristics for Modafinil,” 2015.
[5] Drug Enforcement Administration. “Controlled Substance Schedules,” 2022.