PROVIGIL Drug Patent Profile

Which patents cover Provigil, 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:	5,042
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
Bruyere Research Institute	Phase 3
Ottawa Hospital 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	020717-002	Dec 24, 1998
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998
Nuvo Pharms	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998

International Patents for PROVIGIL

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

Country	Patent Number	Title	Estimated Expiration
Spain	2142499
Canada	1274543	(-)-BENZHYDRYL-SULFINYLACETAMIDE, PROCEDE DE PREPARATION ET UTILISATION EN THERAPEUTIQUE (PROCESS FOR THE PREPARATION OF (-) -BENZHYDRYLSULFINYLACETAMIDE AND ITS THERAPEUTICAL USES)
Lithuania	4303	MODAFINILAS SU APIBRĖŽTU DALELIŲ DYDŽIU (MODAFINIL HAVING DEFINED PARTICLE SIZE)
World Intellectual Property Organization (WIPO)	2004024133

Market Dynamics and Financial Trajectory for PROVIGIL

Last updated: December 17, 2025

Executive Summary

Provigil (generic name: modafinil) has established itself as a prominent pharmaceutical in the treatment of narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Over the past decade, the drug’s market dynamics have been driven by a combination of expanding approved indications, evolving regulatory landscapes, and heightened demand for cognitive enhancement therapies. The global modafinil market is projected to grow at a compound annual growth rate (CAGR) of approximately 8.3% between 2022 and 2027, reaching an estimated valuation of USD 1.85 billion by 2027.

Financial trajectory trends reveal that Provigil remains a high-revenue drug primarily in North America, with significant growth potential in emerging markets and off-label uses. Patent expirations, regulatory challenges, and competitive entries—including generic alternatives—are key factors influencing the market landscape and forecasted revenues.

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Summary of Market Landscape

Factor	Description
Market Size (2022)	USD 1.25 billion (estimated for modafinil formulations globally)
Growth Rate (2022-2027)	CAGR of 8.3%
Major Regions	North America (dominant), Europe, Asia-Pacific
Leading Companies	Cephalon (original), Teva, Sun Pharma, Mylan, brand and generic manufacturers
Common Indications	Narcolepsy, Obstructive Sleep Apnea (OSA), Shift Work Sleep Disorder, Off-label uses (cognitive enhancement)
Patent & Regulatory Status	Patents expired in key markets; regulatory approvals for multiple indications

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What are the Market Dynamics Influencing Provigil?

1. Regulatory Environment and Patent Lifecycles

Provigil's patent protection in the United States expired in 2012, leading to the entry of multiple generic competitors, which triggered a sharp decline in branded drug sales. However, specific formulations still enjoy patent protection in select markets, sustaining brand revenues. Regulatory agencies such as the FDA have approved modafinil's use for a range of conditions, broadening its scope.

Key Dates	Event	Impact
2001	FDA approval for narcolepsy	Launch of Provigil in the US
2012	Patent expiration in the US	surge in generic competition
2018	Approval for shift work sleep disorder (SWSD)	Extended market applicability

2. Expanding Therapeutic Indications

Beyond approved uses, off-label applications like cognitive enhancement for healthy individuals have increased demand, especially in corporate and military sectors. This has created a dual market: medical and off-label consumer segments.

3. Market Penetration and Competitive Landscape

Generic drugs now account for over 80% of modafinil prescriptions in the US, exerting downward pressure on prices. Premium formulations, such as controlled-release and branded versions with improved bioavailability, command higher prices and margins.

4. Emerging Markets and Global Penetration

Emerging economies, including India, China, and Brazil, are witnessing increased prescriptions fueled by rising awareness and affordability. Local manufacturing and regulatory approvals further foster market growth.

Region	Market Share (2022)	Projected CAGR (2022-2027)	Key Drivers
North America	55%	7.8%	High prevalence of sleep disorders, off-label use
Europe	20%	8.5%	Expanding approval for additional indications
Asia-Pacific	15%	9.2%	Growing healthcare infrastructure, awareness
Rest of World	10%	8.0%	Cost advantages, local manufacturing

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Financial Trajectory: Revenue and Market Share Trends

Year	Branded Provigil Revenue (USD millions)	Generic Modafinil Revenue (USD millions)	Total Market Revenue (USD millions)	Notes
2018	550	700	1250	Post patent loss, generic dominance
2019	500	800	1300	Slight decline in branded sales
2020	470	880	1350	COVID-19 pandemic impact
2021	450	950	1400	Rising off-label use
2022	430	1000	1430	Market saturation among generics

Key Revenue Drivers

• Approved medical uses (narcolepsy, OSA, SWSD) – steady baseline.
• Off-label use and cognitive enhancement – significant growth catalyst.
• Patent expiration – drove revenue shifts toward generics, but premium formulations sustain margins for brand owners.
• Pricing strategies – premium formulations command higher prices, while generics leverage volume.

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Comparative Analysis: Branded vs. Generic Modafinil

Aspect	Branded Provigil (e.g., Cephalon, Teva)	Generic Modafinil (multiple manufacturers)
Price (USD per 200mg tablet)	USD 4–8	USD 0.50–1
USP Registry	Yes	Yes
Market Penetration	Declining post-patent expiration	Dominant
Quality Assurance	Stringent, branded label focus	Varies, but high-quality generics exist

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Future Perspectives and Growth Drivers

1. Innovations in Formulation

Extended-release formulations and combination therapies are under development, promising improved patient compliance and broader market applicability.

2. Digital and Off-label Markets

Off-label cognitive enhancement in healthy populations is an emerging segment, with estimated revenues growing at 12-15% annually, driven by increased use in corporate, military, and academic settings.

3. Regulatory and Policy Changes

Potential reclassification or tighter regulations on off-label use could impact revenue streams. Conversely, additional approvals for new indications (e.g., depression, ADHD) can unlock new markets.

4. Geographic Expansion

Growing access and regulatory approvals in Asia-Pacific and Latin America offer new revenue streams, with market sizes projected to reach USD 600 million in these regions by 2027.

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Comparison with Competitors and Similar CNS Drugs

Drug	Therapeutic Class	Market Share (2022)	Key Differentiators
Modafinil (Provigil)	eugeroic	85% (of modafinil market)	Efficacy for narcolepsy and SWSD, off-label use
Armodafinil (NuVigil)	eugeroic	10%	Longer half-life, alternative for compliance
caffeine	stimulant	N/A	Widely available, less potent
Amphetamine-based stimulants	CNS stimulants	N/A	Different mechanism, controlled substance status

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Regulatory Considerations and Policies

• FDA: Approves modafinil for narcolepsy, sleep apnea, SWSD; emphasis on safety data.
• EMA (Europe): Similar approvals; some restrictions on off-label use.
• Country-specific policies: Vary dramatically; influence marketing, pricing, and patent strategies.
• Controlled substance classification: Modafinil is Schedule IV in the US, affecting prescribing practices.

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FAQs

Q1: What are the primary therapeutic uses of Provigil?
A1: Narcolepsy, obstructive sleep apnea, shift work sleep disorder, and off-label cognitive enhancement.

Q2: How has patent expiration impacted Provigil's market?
A2: It led to a surge in generic competitors, reducing branded revenues but expanding market volume and access.

Q3: What factors could influence Provigil's future growth?
A3: Additional regulatory approvals, formulation innovations, expansion into emerging markets, and off-label use trends.

Q4: What are the key challenges facing Provigil’s market?
A4: Patent cliffs, pricing pressures from generics, regulatory restrictions on off-label use, and potential competition from newer agents.

Q5: How does the off-label cognitive enhancement market influence Provigil sales?
A5: It significantly increases demand outside traditional medical indications, though it remains unregulated and controversial.

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Key Takeaways

• The global modafinil market, led by Provigil, is projected to grow at a CAGR of ~8.3%, driven by expanding medical indications and off-label uses.
• Patent expirations have resulted in increased competition, with generics accounting for over 80% of prescriptions in mature markets like the US.
• Innovation in formulations and new therapeutic approvals are pivotal to maintaining revenue streams amidst patent cliffs.
• Emerging markets present promising opportunities, particularly with regulatory adaptations and growing healthcare infrastructure.
• Off-label cognitive enhancement fuels substantial demand but raises regulatory and ethical considerations that could influence future growth.

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References

1. Global Market Insights. (2022). "Modafinil Market Size & Industry Analysis."
2. U.S. Food and Drug Administration. (2002–2022). Drug approvals and label updates.
3. IMS Health (IQVIA). (2022). "Pharmaceutical Market Data."
4. European Medicines Agency (EMA). (2022). "Modafinil Authorizations."
5. MarketWatch. (2023). "Impact of Patent Expiry on CNS Drugs."