MODAFINIL - Generic Drug Details

What are the generic 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 Cephalon, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Modafinil has sixty-two patent family members in twenty-eight countries.

There are twenty-six drug master file entries for modafinil. Twenty suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for MODAFINIL

International Patents:	62
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	165
Patent Applications:	6,909
Drug Prices:	Drug price trends for MODAFINIL
Drug Sales Revenues:	Drug sales revenues 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
Kuwait University	Early Phase 1
Genuine Research Center, Egypt	Phase 1
Chemipharm Pharmaceutical Industries, Egypt	Phase 1

See all MODAFINIL clinical trials

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.

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
Aurobindo Pharma Ltd	MODAFINIL	modafinil	TABLET;ORAL	202566-002	Sep 27, 2012	AB	RX	No	No
Natco Pharma	MODAFINIL	modafinil	TABLET;ORAL	076594-002	Jul 16, 2012		DISCN	No	No
Natco Pharma	MODAFINIL	modafinil	TABLET;ORAL	076594-001	Jul 16, 2012		DISCN	No	No
Apotex	MODAFINIL	modafinil	TABLET;ORAL	077667-001	Feb 3, 2014	AB	RX	No	No
Cadila	MODAFINIL	modafinil	TABLET;ORAL	209966-001	Sep 14, 2017	AB	RX	No	No
Cadila	MODAFINIL	modafinil	TABLET;ORAL	209966-002	Sep 14, 2017	AB	RX	No	No
Apotex	MODAFINIL	modafinil	TABLET;ORAL	077667-002	Feb 3, 2014	AB	RX	No	No

Expired US Patents for MODAFINIL

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

International Patents for MODAFINIL

Country	Patent Number	Title	Estimated Expiration
Germany	60219005
Malaysia	129376	NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL
Norway	20035211
Israel	158959	SOLID PHARMACEUTICAL FORMULATIONS COMPRISING MODAFINIL
Portugal	1556026
Japan	2014028833	NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL
Canada	2498506	NOUVELLES FORMULATIONS PHARMACEUTIQUES DU MODAFINIL (NOVEL PHARMACEUTICAL FORMULATIONS OF MODAFINIL)

MODAFINIL Market Analysis and Financial Projection Experimental

Modafinil Market Dynamics and Financial Trajectory

Introduction to Modafinil

Modafinil, a wakefulness-promoting agent, is widely used to treat sleep disorders such as narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Its market is influenced by a complex interplay of factors, including increasing awareness of sleep disorders, shifting lifestyle patterns, and advancements in healthcare.

Market Drivers

Increasing Awareness of Sleep Disorders

The rising prevalence of sleep disorders has significantly driven the demand for modafinil. As more people become aware of conditions like narcolepsy and sleep apnea, the need for prescription wakefulness-promoting agents increases, contributing to market growth[1][5].

Shift Towards Smart Drugs and Cognitive Enhancers

There is a growing trend among students, professionals, and individuals seeking to enhance their cognitive function and productivity. Modafinil, with its off-label use as a cognitive enhancer, has become a popular choice, driving market demand[1][5].

Growing Healthcare Expenditure

Increasing healthcare spending in various regions has enabled better access to medications, including modafinil. This higher healthcare expenditure is a key driver of market growth, particularly in regions like North America and Europe[1][5].

Aging Population

An aging population is more prone to health issues, including sleep disorders. This demographic shift is expected to drive the demand for modafinil, as older adults seek treatments for these conditions[1].

Evolving Lifestyle Patterns

The fast-paced lifestyle and increasing work hours can lead to sleep deprivation, creating a demand for medications that help individuals stay alert and manage fatigue. This trend is particularly evident in urban and professional settings[1][5].

Market Restraints

Cost and Financial Barriers

The cost of modafinil can be a significant barrier for some patients, especially in regions with limited insurance coverage. Budget constraints in healthcare systems can also affect the availability of the drug[1][5].

Limited Awareness and Knowledge

Despite its benefits, many potential users might still be unaware of modafinil and its uses. Educational efforts are necessary to raise awareness among both consumers and healthcare providers, which can limit market growth until addressed[1][5].

Market Saturation and Competition

The market faces increased competition from generic versions and alternative smart drugs. This competition can saturate the market, making it challenging for original brand-name products to maintain their market share[1][5].

Supply Chain Issues

The pharmaceutical industry often faces challenges such as raw material shortages or disruptions in supply chains. These issues can hinder the production and availability of modafinil[1].

Cultural and Societal Attitudes

In certain regions, cultural attitudes towards using cognitive enhancers or pharmaceuticals for non-medical purposes may restrict market growth. These attitudes can vary significantly across different geographical areas[1].

Market Opportunities

Collaborative Partnerships and Innovations

Collaborative partnerships among pharmaceutical firms can spur innovations in modafinil development, leading to new formulations and improved efficacy. These partnerships can enhance product availability and reach in the market[1][5].

Expanding Use Through Novel Formulations

Identifying opportunities through comparative analysis with alternative cognitive enhancers and leveraging novel formulation initiatives can expand the use of modafinil. Patient-centric approaches and new distribution channels, such as telemedicine, can also facilitate market growth[5].

Leveraging Insurance Stakeholders

Partnerships with insurance stakeholders can improve patient affordability and market accessibility, making modafinil more accessible to a broader audience[5].

Market Challenges

Regulatory Hurdles

The modafinil market is subject to stringent regulatory controls. Obtaining approvals for new formulations or indications can be challenging, and a conducive regulatory environment is crucial for market growth[1][5].

Intellectual Property Disputes

Intellectual property disputes can affect the modafinil branded and generic drug markets. These disputes can impact the market dynamics and the availability of the drug[5].

Counterfeiting

Counterfeiting is a significant challenge in the modafinil market, affecting the reliability of drug brands. Efforts to combat counterfeiting are essential to maintain consumer confidence[5].

Financial Trajectory

Market Size and Forecast

The modafinil market is growing at a moderate pace, with substantial growth rates expected over the forecast period from 2024 to 2031. The market size is estimated to increase significantly due to the factors mentioned above[1][3].

Revenue and Sales

Global modafinil sales and revenue are projected to rise, driven by increasing demand in regions such as North America, Europe, and the Asia-Pacific. The market revenue is expected to grow, with key manufacturers contributing significantly to the overall sales[1][3][5].

Regional Performance

North America, particularly the United States, is a dominant sub-segment due to high healthcare expenditure and the presence of key pharmaceutical companies. Europe follows closely, with countries like Germany, France, and the UK showing rising investment in sleep disorder treatments. The Asia-Pacific region is emerging as a significant sub-segment, driven by a rapidly growing population and increasing acceptance of nootropic drugs[1][3].

Key Players and Competition

Major Manufacturers

The market is characterized by competition among major manufacturers. The top manufacturers are expected to maintain their market share through continuous research and development, strategic alliances, and effective distribution strategies[1][3].

Generic and Branded Versions

The market faces competition from both generic and branded versions of modafinil. Generic versions can offer cost-effective alternatives, while branded versions focus on maintaining their market share through innovation and marketing efforts[1][5].

Future Outlook

Research and Development

Continuous research and development are expected to enhance the efficacy and safety of modafinil, leading to the introduction of new products in the market. This could include novel formulations and improved delivery systems[1][4].

Emerging Markets

The rise of healthcare infrastructure in emerging markets is expected to drive market growth significantly. Countries such as India and China are anticipated to witness robust growth due to enhancing healthcare infrastructure and an expanding middle-class population prioritizing mental wellness and productivity[1][3].

Key Takeaways

• The modafinil market is driven by increasing awareness of sleep disorders, the trend towards cognitive enhancers, and growing healthcare expenditure.
• Market growth is restrained by financial barriers, limited awareness, market saturation, and supply chain issues.
• Opportunities exist through collaborative partnerships, novel formulations, and leveraging insurance stakeholders.
• Regulatory hurdles, intellectual property disputes, and counterfeiting are significant challenges.
• The market is expected to grow significantly over the forecast period, driven by regional demand and continuous innovation.

FAQs

Q: What are the primary uses of modafinil?

Modafinil is primarily used to treat sleep disorders such as narcolepsy, obstructive sleep apnea, and shift work sleep disorder. It is also used off-label as a cognitive enhancer to improve focus and productivity.

Q: What are the key drivers of the modafinil market?

The key drivers include increasing awareness of sleep disorders, the trend towards cognitive enhancers, growing healthcare expenditure, and an aging population.

Q: What are the major challenges facing the modafinil market?

The major challenges include financial barriers, limited awareness, market saturation, supply chain issues, and cultural and societal attitudes towards cognitive enhancers.

Q: How is the modafinil market expected to grow in the future?

The modafinil market is expected to grow significantly over the forecast period from 2024 to 2031, driven by regional demand, continuous innovation, and emerging markets.

Q: What role do generic versions play in the modafinil market?

Generic versions of modafinil offer cost-effective alternatives, which can increase market competition and impact the market share of branded versions.

Sources

1. Verified Market Research: Modafinil Market Size, Share, Growth, Trends, Scope & Forecast.
2. Wall Street Oasis: Nootropics (Modafinil etc.) in Hedge Funds.
3. QYResearch: Global Modafinil Market Insights, Forecast to 2030.
4. Frontiers in Neuroscience: Modafinil Reduces Neuronal Pyroptosis and Cognitive Decline After Sleep Deprivation.
5. 360iResearch: Modafinil Oral Drugs Market Size & Share 2025-2030.