PROVIGIL Drug Patent Profile

When do Provigil patents expire, and what generic alternatives are available?

Provigil is a drug marketed by Nuvo Pharms and is included in one NDA.

The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the modafinil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Provigil

A generic version of PROVIGIL was approved as modafinil by ORBION PHARMS on September 26^th, 2012.

Summary for PROVIGIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	71
Patent Applications:	5,327
Drug Prices:	Drug price information for PROVIGIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROVIGIL
What excipients (inactive ingredients) are in PROVIGIL?	PROVIGIL excipients list
DailyMed Link:	PROVIGIL at DailyMed

See drug prices for PROVIGIL

See drug sales revenues for PROVIGIL

Recent Clinical Trials for PROVIGIL

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

Sponsor	Phase
Kuwait University	Early Phase 1
The Ottawa Hospital	Phase 3
Bruyere Research Institute	Phase 3

See all PROVIGIL clinical trials

Pharmacology for PROVIGIL

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

US Patents and Regulatory Information for PROVIGIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	AB	RX	Yes	No
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	AB	RX	Yes	Yes

Expired US Patents for PROVIGIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998

International Patents for PROVIGIL

See the table below for patents covering PROVIGIL around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	188607
Hong Kong	1078265
Norway	333725

PROVIGIL Market Analysis and Financial Projection

Last updated: February 8, 2026

What is the current market size and forecast for PROVIGIL?

The global market for PROVIGIL (modafinil) was valued at approximately $740 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.8% from 2023 to 2030, reaching around $1100 million by 2030 (Research and Markets, 2023). The growth is driven by increasing demand for sleep disorder treatments and off-label use for cognitive enhancement.

How does the regulatory landscape impact PROVIGIL's market trajectory?

FDA Approval and Restrictions: PROVIGIL has FDA approval for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with obstructive sleep apnea. Nonetheless, it faces regulatory scrutiny over off-label prescribing practices, which influence market dynamics. The U.S. Drug Enforcement Administration (DEA) classifies modafinil as a Schedule IV controlled substance, impacting distribution and prescribing patterns.

Global Regulatory Variability: Multiple countries maintain different regulatory stances. Europe approves similar indications but has tighter restrictions, limiting market penetration. Emerging markets display increased approval but lack uniform oversight, affecting sales growth in those regions.

Patent and Patent Expirations: The original patent for PROVIGIL expired in 2012, leading to a spike in generic versions. Generics have constituted over 70% of U.S. sales since then, impacting pricing power and profit margins for branded versions.

What are the key drivers and barriers influencing PROVIGIL's financial performance?

Drivers:

• Increasing Sleep Disorder Prevalence: Globally, narcolepsy affects approximately 25-50 per 100,000 people, with rising awareness and diagnosis fueling demand.
• Off-label Use for Cognitive Enhancement: Growing interest from healthy individuals and students contributes to revenue, although off-label use is unapproved.
• Expanding Indications: Research explores potential for ADHD, depression, and shift work disorders, indicating avenues for future growth.

Barriers:

• Generic Competition: Post-2012 patent expiry, generics have lowered prices, reducing revenue per unit.
• Regulatory Constraints: Stringent prescribing regulations and Schedule IV classification may cap prescribing volumes.
• Safety Concerns: Reports of adverse effects such as skin reactions and potential abuse implications restrict market expansion.

How does the financial trajectory compare to competitors and similar drugs?

Drug	Market Size (2022)	CAGR (2023-2030)	Key Notes
Modafinil (PROVIGIL)	$740M	4.8%	Led the market; generic availability high
Armodafinil (Nuvigil)	~$300M	3.5%	Slightly newer; used for similar indications
Adderall (amphetamine/dextroamphetamine)	$1.4B	4.2%	Competes indirectly; prescribed for ADHD

The market for brand-name drugs like PROVIGIL faces pressure from generics and equivalents, which collectively dominate sales.

What are the prospects for investment or R&D?

Investment in R&D focuses on expanding indications and improving formulations. Trials explore modafinil for fatigue in cancer, multiple sclerosis, and COVID-19 recovery. These efforts could enhance revenue streams despite market saturation.

Pharmaceutical companies are also considering developing next-generation wakefulness agents with higher efficacy, lower abuse potential, and fewer side effects, potentially capturing novel market segments.

What are the key takeaways?

• Market growth is steady, driven chiefly by sleep disorder diagnoses and off-label cognitive use.
• Generic competition has lowered brand revenue, but expansion into new indications offers future upside.
• Regulatory elements, including Schedule IV status, influence distribution and prescribing.
• Geographic variability plays a vital role in sales; emerging markets could see increased adoption.
• R&D efforts targeting expanded uses and improved formulations aim to mitigate current market limitations.

FAQs

1. What are the primary approved uses of PROVIGIL?
FDA-approved for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness from obstructive sleep apnea.

2. How do generics affect PROVIGIL’s profitability?
They decrease average selling prices and profit margins, accounting for over 70% of U.S. sales since patent expiration.

3. What regulatory challenges does PROVIGIL face globally?
Increased restrictions and classification as Schedule IV impact manufacturing, prescribing, and distribution; approval varies across regions.

4. What off-label uses are popular for PROVIGIL?
Cognitive enhancement among healthy individuals, including students and professionals, although these are unapproved indications.

5. Are there new formulations or indications under development?
Yes, research investigates PROVIGIL for fatigue-related conditions in chronic illnesses and potential new wakefulness agents with improved safety profiles.

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References

1. Research and Markets. (2023). Global Modafinil Market Report.
2. U.S. Food and Drug Administration. (2023). PROVIGIL prescribing information.
3. IQVIA. (2022). U.S. prescription drug sales data.
4. European Medicines Agency. (2022). Approval status for modafinil.
5. Drug Enforcement Administration. (2022). Controlled substances scheduling.