PROVIGIL Drug Patent Profile

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

Provigil is a drug marketed by Cephalon and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty 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

International Patents:	62
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	71
Patent Applications:	4,385
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
Ottawa Hospital Research Institute	Phase 3
The Ottawa Hospital	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
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	AB	RX	Yes	No	7,297,346*PED
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	AB	RX	Yes	Yes	7,297,346*PED

Expired US Patents for PROVIGIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	RE37516*PED
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	RE37516*PED
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	7,297,346*PED
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	4,177,290
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,927,855*PED
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	4,177,290

International Patents for PROVIGIL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	152207
Lithuania	4303	MODAFINILAS SU APIBRĖŽTU DALELIŲ DYDŽIU (MODAFINIL HAVING DEFINED PARTICLE SIZE)
Netherlands	7803432
Canada	2201967	MODAFINIL AYANT UNE GRANULOMETRIE DEFINIE (ACETAMIDE DERIVATIVE HAVING DEFINED PARTICLE SIZE)
Canada	2382275	MODAFINIL A GROSSEUR DE PARTICULE DEFINI (MODAFINIL HAVING DEFINED PARTICLE SIZE)
Ireland	59832	(-)-benzhydrylsulfinylacetamide

PROVIGIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Provigil (Modafinil)

Introduction

Provigil, the brand name for the drug modafinil, is a wakefulness-promoting agent widely used to treat sleep disorders such as narcolepsy, obstructive sleep apnea, and shift work sleep disorder. The market dynamics and financial trajectory of Provigil are influenced by a complex interplay of factors, including regulatory environments, consumer demand, competitive landscape, and strategic business decisions.

Market Drivers

Increasing Awareness of Sleep Disorders

The rising prevalence of sleep disorders has significantly increased the demand for prescription wakefulness-promoting agents like modafinil. As awareness about these conditions grows, more patients are seeking medical treatment, driving the market for Provigil[1].

Shift Towards Smart Drugs and Cognitive Enhancers

The trend towards using nootropics and cognitive enhancers among students, professionals, and individuals seeking increased productivity and cognitive function has expanded the market base for modafinil beyond its traditional therapeutic uses[1].

Growing Healthcare Expenditure

Increasing healthcare spending in various regions has enabled better access to medications, including Provigil, leading to higher market penetration. This is particularly evident in North America and Europe, where high healthcare expenditure supports the growth of the modafinil market[1].

Aging Population

An aging population is more prone to various health issues, including sleep disorders, which is expected to drive the demand for Provigil for treatment. As the global population ages, the need for medications like modafinil is anticipated to increase[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 lifestyle shift contributes to the growing market for Provigil[1].

Market Restraints

Pricing Pressures

High pricing of branded modafinil, such as Provigil, can be a significant barrier for many patients, especially in regions with limited insurance coverage. The cost of Provigil has been a point of contention, with instances where patients faced substantial increases in copays and deductibles[5].

Regulatory and Legal Challenges

Provigil has been involved in several legal issues, including antitrust litigation related to pay-for-delay agreements. For example, Sun Pharma and Mylan settled lawsuits for $150 million and $96.5 million, respectively, which impacted their financial performance[2].

Market Saturation and Competition

The market for modafinil is becoming increasingly saturated with generic versions and alternative smart drugs. This competition makes it challenging for original brand-name products like Provigil to maintain their market share[1].

Supply Chain Issues

The pharmaceutical industry often faces challenges such as raw material shortages or disruptions in supply chains, which can hinder the production and availability of Provigil. For instance, Sun Pharma faced issues related to FDA manufacturing restraints at its Halol plant in India[2].

Financial Trajectory

Historical Performance

Historically, Provigil has been a lucrative drug for its manufacturers. For example, Cephalon, the original developer of Provigil, reported significant sales, with US sales reaching $417 million in the first half of 2007 and total sales of $744 million for that year[5].

Impact of Litigation and Regulatory Issues

However, the financial performance of companies involved in the modafinil market has been impacted by litigation and regulatory issues. Sun Pharma's profit was severely affected by a $150 million settlement for antitrust litigation related to Provigil, contributing to a 74% slide in its profit last quarter[2].

Pricing Strategies and Patient Assistance Programs

Companies have employed various pricing strategies and patient assistance programs to manage market dynamics. For instance, Cephalon closed its Provigil Patient Assistance Program, which was seen as a strategic move possibly in anticipation of promoting its successor drug, Nuvigil (armodafinil)[5].

Geographic Market Dynamics

North America

North America, particularly the United States, is a dominant market for Provigil due to high healthcare expenditure, the presence of key pharmaceutical companies, and increasing awareness of cognitive enhancement drugs. However, this market is also subject to stringent regulations and competitive pressures[1].

Europe

Europe follows closely, with countries like Germany, France, and the UK showing rising investment in sleep disorder treatments alongside stringent regulations governing pharmaceutical products. The European market is characterized by a mix of mature and emerging segments[1].

Asia-Pacific

The Asia-Pacific region is emerging as a significant sub-segment of the modafinil market, driven by a rapidly growing population, a rising incidence of sleep-related disorders, and increasing acceptance of nootropic drugs. Local markets in 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].

Market Opportunities

Expanding Healthcare Infrastructure

The expansion of healthcare infrastructure, especially in emerging markets, presents significant opportunities for the modafinil market. This includes the rise of telemedicine, which has facilitated access to modafinil prescriptions in remote areas[4].

Research and Development

Continuous research and development to enhance the efficacy and safety of modafinil and its formulations may lead to the introduction of new products in the market. Innovations such as extended-release versions or combination therapies can address unmet clinical needs and drive market growth[1][4].

Strategic Alliances and Mergers

Partnerships between pharmaceutical companies for research, manufacturing, and distribution can enhance product availability and reach in the market. These alliances can also help in navigating regulatory environments and expanding market presence[1].

Leveraging Technology

Innovations in patient adherence technologies, such as smart drug delivery systems that track consumption patterns, and the use of artificial intelligence and big data analytics for precision marketing and targeted patient education, offer growth potential for the modafinil market[4].

Market Challenges

Limited Awareness and Knowledge

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

Ethical Concerns and Regulatory Scrutiny

Ethical concerns over off-label use and regulatory scrutiny remain significant challenges. Companies must invest in advanced research and strategies to educate end-users on safe consumption to address these issues[4].

Cultural and Societal Attitudes

In certain regions, cultural attitudes towards using cognitive enhancers or pharmaceuticals for non-medical purposes may restrict market growth. Understanding these regional dynamics is crucial for stakeholders to tailor their approaches effectively[1].

Key Takeaways

• The modafinil market, including Provigil, is driven by increasing awareness of sleep disorders, the trend towards cognitive enhancers, and growing healthcare expenditure.
• Regulatory and legal challenges, such as pay-for-delay agreements and stringent regulatory controls, impact the financial trajectory of companies involved.
• Geographic market dynamics vary significantly, with North America and Europe being dominant but facing competition and regulatory pressures, while the Asia-Pacific region offers emerging opportunities.
• Market opportunities include expanding healthcare infrastructure, research and development, strategic alliances, and leveraging technology.
• Challenges such as limited awareness, ethical concerns, and cultural attitudes need to be addressed through educational efforts and strategic business decisions.

FAQs

What are the primary drivers of the modafinil market?

The primary drivers include increasing awareness of sleep disorders, the trend towards cognitive enhancers, and growing healthcare expenditure.

How has litigation impacted the financial performance of companies involved in the modafinil market?

Litigation, such as pay-for-delay agreements, has significantly impacted the financial performance of companies like Sun Pharma and Mylan, leading to substantial settlement costs and reduced profits.

What are the key geographic markets for modafinil?

The key geographic markets include North America, Europe, and the Asia-Pacific region, each with unique dynamics and opportunities.

What are some of the challenges facing the modafinil market?

Challenges include limited awareness and knowledge, ethical concerns over off-label use, regulatory scrutiny, and cultural and societal attitudes towards cognitive enhancers.

How can companies leverage technology to drive market growth?

Companies can leverage technology through innovations in patient adherence, smart drug delivery systems, and the use of artificial intelligence and big data analytics for precision marketing and targeted patient education.

Sources

1. Verified Market Research: Modafinil Market Size, Share, Growth, Trends, Scope & Forecast.
2. FiercePharma: Sun's profit crushed as it pays $150M to settle Provigil pay-for-delay case.
3. Minnesota.gov: EVV provider onboarding guide.
4. 360iResearch: Modafinil Oral Drugs Market Size & Share 2025-2030.
5. Community Catalyst: Why did Cephalon close its Provigil Patient Assistance Program.