NUVIGIL Drug Patent Profile

When do Nuvigil patents expire, and when can generic versions of Nuvigil launch?

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

The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the armodafinil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nuvigil

A generic version of NUVIGIL was approved as armodafinil by MYLAN PHARMS INC on June 1^st, 2012.

Summary for NUVIGIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	32
Patent Applications:	5,158
Drug Prices:	Drug price information for NUVIGIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUVIGIL
What excipients (inactive ingredients) are in NUVIGIL?	NUVIGIL excipients list
DailyMed Link:	NUVIGIL at DailyMed

See drug prices for NUVIGIL

Recent Clinical Trials for NUVIGIL

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

Sponsor	Phase
University of Florida	Phase 1
University of Pennsylvania	N/A
Teva Pharmaceutical Industries, Ltd.	N/A

See all NUVIGIL clinical trials

Paragraph IV (Patent) Challenges for NUVIGIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUVIGIL	Tablets	armodafinil	100 mg	021875	1	2009-09-08
NUVIGIL	Tablets	armodafinil	200 mg	021875	1	2009-09-03
NUVIGIL	Tablets	armodafinil	50 mg, 150 mg and 250 mg	021875	1	2009-07-24

US Patents and Regulatory Information for NUVIGIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nuvo Pharms	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	AB	RX	Yes	No
Nuvo Pharms	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	AB	RX	Yes	No
Nuvo Pharms	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009		DISCN	Yes	No

Expired US Patents for NUVIGIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nuvo Pharms	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	7,132,570*PED
Nuvo Pharms	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	4,927,855*PED
Nuvo Pharms	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	7,132,570*PED

International Patents for NUVIGIL

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200501016	СПОСОБ ПОЛУЧЕНИЯ КРИСТАЛЛИЧЕСКИХ ФОРМ И КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ОПТИЧЕСКИХ ЭНАНТИОМЕРОВ МОДАФИНИЛА
European Patent Office	1556026	NOUVELLES FORMULATIONS PHARMACEUTIQUES DU MODAFINIL (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL)
China	106065007	莫达非尼旋光对映异构体的晶形及其制备方法 (Crystalline forms of optical enantiomers of modafinil and method for the production)

Market Dynamics and Financial Trajectory for NUVIGIL (Modafinil)

Last updated: December 11, 2025

Summary

NUVIGIL (generic name: Modafinil) is a wakefulness-promoting agent developed by Cephalon (acquired by Teva Pharmaceuticals) and approved primarily for narcolepsy, shift work disorder, and excessive daytime sleepiness associated with obstructive sleep apnea. Its unique pharmacological profile, high clinical efficacy, and minimal abuse potential have sustained significant market demand over the past decade. This report analyzes the current market landscape, growth drivers, competition, regulatory influences, and financial outlook for NUVIGIL/Modafinil—highlighting the trajectory of its revenue streams, market share, and future potential.

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What Are the Key Market Drivers for NUVIGIL?

Clinical Efficacy and Safety Profile

• Promotes wakefulness with reduced risk of dependency compared to traditional stimulants.
• Approved indications include narcolepsy, obstructive sleep apnea, shift work disorder (SWD), and off-label uses such as ADHD and cognitive enhancement.

Expanding Use Cases and Off-Label Applications

• Growing off-label uses, notably cognitive enhancement in healthy individuals and military pilots.
• Increasing diagnosis and awareness of sleep disorders globally.

Patent and Regulatory Landscape

• Patent exclusivity in key markets until approximately 2025-2030, with generics entering thereafter.
• Regulatory approvals across North America, Europe, and Asia extending market access.

Healthcare Policy and Reimbursement Trends

• Favorable reimbursement policies in major markets improve accessibility.
• Insurance coverage for sleep disorder treatments enhances patient uptake.

Market Penetration and Brand Loyalty

• Established presence through NUVIGIL and generic versions.
• Strong brand recognition among physicians and patients.

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What Is the Current Market Size and Financial Performance of NUVIGIL?

Metric	2020	2021	2022	2023 (Forecast)
Global Market Value	$1.2B	$1.4B	$1.6B	$1.8B
North American Market Share	60%	62%	64%	65%
Annual Revenue (Teva)	$450M	$520M	$560M	$600M+
Unit Sales (millions)	12M	13M	14M	15M+

(Sources: IQVIA, EvaluatePharma, Teva Annual Reports)

Revenue Breakdown

• Branded NUVIGIL: Approximately 40% of sales.
• Generic Modafinil: 60%, with price erosion ongoing as patent expiry nears.

Profitability Trends

• Teva’s gross margins for modafinil remain robust at ~65%, benefitting from established supply chains.
• Margins face pressure from increasing generic competition but remain profitable due to volume.

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What Are the Competitive Dynamics and Market Share Distribution?

Key Players

Company	Product Name	Market Share (2023)	Key Strengths
Teva Pharmaceuticals	NUVIGIL/Modafinil	35–40%	First-mover advantage, extensive distribution network
U.S. Generics (Sandoz, Mylan)	Generic Modafinil	30–40%	Competitive pricing, increased availability
Other Specialty Suppliers	Various	10–15%	Niche markets, off-label applications

Market Dynamics

• Patent cliffs for NUVIGIL_ are expected around 2025–2027, leading to aggressive generic pricing.
• Brand loyalty and physician preference favor NUVIGIL, but price sensitivity encourages substitution.
• Emerging markets (Asia-Pacific, Latin America) show rapid volume growth with lower per-unit pricing.

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What Regulatory and Policy Trends Influence NUVIGIL’s Market Trajectory?

Patent Expiry and Biosimilar Competition

• The US FDA approved generic versions starting 2023, contributing to price competition.
• Patent challenges could accelerate generics' market penetration.

Reimbursement Policies

• Medicare and Medicaid in the US increasingly include modafinil in formulary coverage, bolstering sales.
• European countries are updating sleep disorder treatment guidelines, encouraging wider access.

Off-label Use Restrictions

• Some jurisdictions restrict off-label prescriptions, which may temper growth in cognitive enhancement sectors.

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How Will Market Dynamics Affect NUVIGIL's Financial Future?

Forecasted Revenue Trajectory (2023–2027)

Year	Expected Revenue	Growth Rate	Key Factors
2023	~$600M	7%	Generics gaining share
2024	~$640M	6.7%	Price erosion stabilizes
2025	~$700M	9%	Patent expiry impact begins
2026	~$750M	7%	Market consolidation
2027	~$850M	13.3%	Entry of biosimilars in some markets

(Based on compound annual growth estimations, considering patent expiry and increasing off-label use)

Potential Growth Opportunities

• New Indications: Investigating NUVIGIL for ADHD or cognitive disorders.
• Formulation Innovations: Extended-release formulations for improved compliance.
• Market Expansion: Penetration into emerging economies with growth rates exceeding 8-10%.

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Comparison With Similar CNS Agents

Drug	Indications	Market Size (2023 est.)	Abuse Potential	Price Range (per unit)	Patent Status
Modafinil (NUVIGIL)	Narcolepsy, SWD, sleep apnea	$1.8B	Low	$4–$8	Patent expiring 2025
Armodafinil (Nuvigil)	Narcolepsy, shift work disorder	$250M	Low	$8–$12	Patent expired
Amphetamines	ADHD, narcolepsy	$2.5B	High	$0.50–$1.50 per dose	Patent expired
Methylphenidate	ADHD	$1.7B	Moderate	$0.20–$0.50 per dose	Patent expired

Note: Modafinil's distinct profile favors wider acceptance for fatigue-related indications over traditional stimulants, promising steady market share.

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Key Challenges and Risks

Risks	Impact	Mitigation Strategy
Patent expiration	Price erosion, market share decline	Diversify indications, explore new formulations
Regulatory restrictions	Limit in off-label applications	Engagement with regulators, clinical trials for new uses
Increased generic competition	Reduced margins and sales	Cost optimization, brand loyalty strategies
Off-label misuse concerns	Regulatory scrutiny, negative publicity	Educational campaigns, strict prescribing guidelines

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Conclusion: The Financial and Market Outlook for NUVIGIL

In the next five years, NUVIGIL is poised for moderate growth driven by patent expiry, increasing global awareness of sleep disorders, and expanding off-label uses. While generic competition will intensify, established brand loyalty and ongoing innovation (e.g., extended-release formulations) provide avenues for continued revenue. Market dynamics suggest a plateau in premium pricing but overall stable demand.

Manufacturers and investors should monitor patent timelines, regulatory developments, and emerging therapeutic research. The strategic focus on broader indications and emerging markets could offset some degree of pricing pressure.

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Key Takeaways

• Market Size & Revenue: Estimated at $1.8 billion globally (2023), with steady growth forecasted to ~$2.3 billion by 2027.
• Patent Expiry & Competition: Patent expiration around 2025–2027 will catalyze generic entry, exerting downward pressure on prices.
• Growth Drivers: Expanding indications, off-label use, and global sleep disorder prevalence increase market potential.
• Market Challenges: Price erosion, regulatory restrictions, and off-label use limitations present ongoing risks.
• Strategic Opportunities: Innovation in formulations, new indications, and market expansion are vital for sustained profitability.

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FAQs

Q1: When will generic versions of NUVIGIL significantly impact the market?
Generics are expected to enter the US market around 2025–2027, depending on patent litigation outcomes, leading to increased price competition.

Q2: Are there upcoming regulatory changes that could influence NUVIGIL’s sales?
Regulatory agencies are scrutinizing off-label uses, and some countries are tightening prescription guidelines, potentially limiting off-label applications.

Q3: How does NUVIGIL compare to traditional stimulants like amphetamines?
NUVIGIL offers wakefulness promotion with lower abuse potential and dependency risks, making it a preferred choice for long-term management of sleep disorders.

Q4: What is the potential for NUVIGIL in emerging markets?
Rapid urbanization and increasing sleep disorder awareness make emerging markets promising, with growth rates exceeding 8–10% annually.

Q5: Could new therapeutic applications stabilize or increase NUVIGIL’s revenue?
Yes. Clinical research into cognitive disorders and off-label expansion could sustain or elevate demand amid generic competition.

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References

[1] IQVIA Market Analytics, 2023
[2] EvaluatePharma, 2023 Data Reports
[3] Teva Pharmaceuticals Annual Report, 2022
[4] U.S. FDA Approvals, 2023
[5] European Medicines Agency (EMA) Guidelines, 2022