modafinil - Profile

What are the generic drug sources for modafinil and what is the scope of freedom to operate?

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 four tentative approvals for this compound.

Summary for modafinil

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for modafinil

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.

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
Alembic	MODAFINIL	modafinil	TABLET;ORAL	202700-001	Oct 18, 2012	AB	RX	No	No
Alembic	MODAFINIL	modafinil	TABLET;ORAL	202700-002	Oct 18, 2012	AB	RX	No	No
Apotex	MODAFINIL	modafinil	TABLET;ORAL	077667-001	Feb 3, 2014	AB	RX	No	No
Apotex	MODAFINIL	modafinil	TABLET;ORAL	077667-002	Feb 3, 2014	AB	RX	No	No
Appco	MODAFINIL	modafinil	TABLET;ORAL	207196-001	Aug 16, 2017	AB	RX	No	No
Appco	MODAFINIL	modafinil	TABLET;ORAL	207196-002	Aug 16, 2017	AB	RX	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	020717-001	Dec 24, 1998	4,177,290
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
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	5,618,845

Last updated: February 3, 2026

What is the Investment Outlook for Modafinil?

Modafinil, a wakefulness-promoting agent primarily prescribed for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness, has attracted interest for its off-label use as a cognitive enhancer. As of 2023, its global market value surpasses $1 billion, driven by increasing awareness and expanding applications. Competitive dynamics, patent holdings, regulatory pathways, and patent expiry timelines shape the investment potential.

What Are the Market Dynamics and Growth Drivers?

Market Size and Drivers

• Estimated global market size: $1.2 billion in 2023.
• Compound annual growth rate (CAGR): approximately 8% from 2023 to 2028.
• Key drivers: rising prevalence of sleep disorders, off-label cognitive enhancement demand, aging populations, and adoption in military and professional sectors.

Geographical Segmentations

Region	Market Share (2023)	Growth Rate (CAGR 2023-2028)
North America	45%	7%
Europe	25%	6%
Asia-Pacific	20%	10%
Rest of World	10%	8%

Competitive Landscape

• Major players: Cephalon (now Teva), H. Lundbeck A/S, and generic manufacturers.
• Patent exclusivity: patents expired or nearing expiry in key markets, opening potential for generics.
• Off-label use: creates revenue streams outside traditional prescriptions but increases regulatory scrutiny.

What Are the Regulatory and Patent Considerations?

Patent Status

• Critical patents: expired or expiring in the next 2-3 years in the U.S. and Europe.
• Implication: generic entry expected post-patent expiry elevates competition and curtails brand premiums.

Regulatory Environment

• FDA approvals: established for narcolepsy, sleep disorders.
• Off-label use: not regulated, but prescribing practices may vary.
• Controlled Substance Schedule: classified as Schedule IV in the U.S., which influences manufacturing, distribution, and prescribing protocols.

Developmental and Regulatory Pathways

• Off-label applications lack formal regulatory pathways.
• New formulations or delivery methods (e.g., extended-release) could require FDA approval, extending time-to-market.

What Are the Fundamentals and Investment Risks?

Revenue and Profitability

• Revenue is highly dependent on branding, patent protection, and off-label sales.
• Historically, brand-name formulations have higher margins; generics pressure margins downward.
• R&D expenditures are moderate; high costs are associated with formulation improvements or new delivery systems.

Patent Expiry Impact

• Market entry of generics expected within 1-3 years in dominant markets.
• Price erosion predicted to be 50-70% within 3 years post patent expiry.
• Strategic positioning: firms with pipeline drugs or alternative formulations will be better insulated.

Supply Chain and Manufacturing

• Supply chain relies on standard APIs from Chinese and Indian manufacturers.
• Any disruption in raw material supply could impact availability and pricing.

Ethical and Legal Risks

• Off-label use risks regulatory scrutiny.
• Potential for misuse and abuse, given the psychoactive effects, could evoke tighter controls.

What Is the Investment Outlook?

• Short-term (1-2 years): volatility expected from patent cliffs and generics entry.
• Medium-to-long term (3-5 years): growth hinges on expanding applications and pipeline developments.
• promising for companies with proprietary formulations or pipeline drugs related to cognitive enhancement or sleep disorders.

What Are the Key Takeaways?

• Market growth driven by off-label use and sleep disorder prevalence.
• Patent expiries threaten branded sales, boosting generic competition.
• Regulatory environment critical in shaping new formulations and use cases.
• Supply chain vulnerabilities and legal risks pose potential operational challenges.
• Long-term prospects depend on pipeline success and market expansion into new therapeutic areas.

What Are Common FAQs?

1. When do key patents for modafinil expire?

Most patents in the U.S. and Europe are set to expire between 2024 and 2026, enabling generic competition.

2. How does off-label use impact the market?

It increases revenue but can attract regulatory scrutiny and complicate reimbursement strategies.

3. Are there new formulations in development?

Extended-release formulations and combination therapies are under investigation, requiring further regulatory approval.

4. What are the main risks for investors?

Patent expiration, regulatory changes, generic price erosion, and supply chain disruptions.

5. How does regulatory status affect market entry?

Approval and scheduling decisions influence manufacturing, marketing rights, and potential restrictions on distribution.

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References

1. Statista. (2023). Modafinil market size worldwide.
2. FDA. (2023). Approved indications for modafinil.
3. European Medicines Agency. (2023). Modafinil authorization details.
4. IQVIA. (2023). Prescription trends and off-label use statistics.
5. PatentScope. (2023). Modafinil patents and expiry dates.