NUVIGIL Drug Patent Profile

Which patents cover Nuvigil, and what generic alternatives are available?

Nuvigil is a drug marketed by Cephalon and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and sixteen patent family members in thirty-one countries.

The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve 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

International Patents:	116
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	32
Patent Applications:	4,464
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
Teva Pharmaceutical Industries, Ltd.	N/A
University of Pennsylvania	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
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-001	Jun 15, 2007	AB	RX	Yes	No
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	AB	RX	Yes	No
Cephalon	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
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007

International Patents for NUVIGIL

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

Country	Patent Number	Title	Estimated Expiration
Lithuania	4303	MODAFINILAS SU APIBRĖŽTU DALELIŲ DYDŽIU (MODAFINIL HAVING DEFINED PARTICLE SIZE)
Israel	158959	SOLID PHARMACEUTICAL FORMULATIONS COMPRISING MODAFINIL
Japan	H06102623

NUVIGIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NUVIGIL (Armodafinil)

Introduction to NUVIGIL (Armodafinil)

NUVIGIL, known generically as Armodafinil, is a wakefulness-promoting agent used primarily to treat narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder. It enhances alertness and is increasingly recognized for its cognitive enhancement properties.

Market Size and Growth

The Armodafinil market, which includes NUVIGIL, is projected to exhibit a robust Compound Annual Growth Rate (CAGR) of 4.50% during the forecast period from 2024 to 2031. This growth is driven by increasing awareness of sleep disorders, a rising demand for effective treatments, and the growing trend of cognitive enhancement in professional environments[1][4].

Regional Market Analysis

North America

The North American market, particularly the United States and Canada, is the largest segment for Armodafinil. This region is valued at approximately $1.5 billion and is growing at a CAGR of 7%. Key factors driving this growth include a well-established healthcare infrastructure, rising awareness of sleep apnea, and an increase in workplace productivity demands. Telemedicine and personalized medicine opportunities are also emerging trends in this region[1][4].

Asia-Pacific

The Asia-Pacific region is another significant market, projected to reach $500 million with a CAGR of 10%. Countries like Japan, Australia, China, and India are driving this growth due to rising awareness of sleep disorders and cognitive enhancement. The surge in e-commerce platforms for medicine distribution and increasing mental health awareness are additional factors contributing to market expansion in this region[1][4].

Middle East & Africa

In the Middle East and Africa, the Armodafinil market is estimated at $150 million, growing at a rate of 9% CAGR. Urban areas, particularly in the UAE and South Africa, are seeing increased awareness of mental health and sleep disorders, which is driving demand. The rise of telehealth services is also expected to facilitate easier access to treatment[1].

Key Players and Competitive Landscape

The Armodafinil market is characterized by a competitive landscape dominated by several key players:

• Teva Pharmaceuticals: As a market leader, Teva employs strategies focused on cost leadership and broad distribution channels, capturing around 30% of the market share[4].
• Mylan: Mylan leverages its robust research and development capabilities to innovate and build a diverse product range, accounting for approximately 25% of the market[4].
• Apotex: Apotex prioritizes aggressive pricing strategies to enhance its market share. Other notable players include Lupin, Sandoz, Natco Pharma, and Aurobindo, which are working to increase their presence through competitive pricing and strategic partnerships[1][4].

Market Dynamics and Challenges

Driving Factors

• Increasing Awareness: Growing awareness of sleep disorders and cognitive enhancement needs is a significant driver of the market.
• Expanding Patient Population: The increasing number of shift workers and individuals with lifestyle-induced fatigue is contributing to market growth.
• Product Innovation: Strategies focusing on product innovation and strategic collaborations among pharmaceutical companies are fueling market expansion.
• Generic Versions: The advent of generic versions of Armodafinil is making the drug more accessible and cost-effective, positively influencing market dynamics[1][4].

Challenges

• Regulatory Scrutiny: Stringent regulatory approvals can hinder market growth.
• Side Effects: Potential side effects and the presence of alternative treatments for sleep disorders and cognitive enhancement are challenges.
• Lack of Awareness: A lack of awareness among healthcare professionals and patients about the benefits of Armodafinil could slow adoption rates[1][4].

Financial Performance of Key Players

Teva Pharmaceuticals

Teva, a major player in the Armodafinil market, reported revenues of $21.9 billion in 2016, an increase of 11% compared to 2015. The company's non-GAAP operating income was $6.8 billion, up 11% from the previous year. Teva's financial performance is indicative of the market's potential, with significant revenues generated from its generic and specialty medicines segments[2].

Other Players

Companies like Mylan, Apotex, and Aurobindo are also performing well, with Aurobindo's revenue reaching approximately $2.2 billion in 2021. These companies' aggressive pricing strategies and expanding global footprints are key factors in their financial success[1][4].

Emerging Trends and Opportunities

Telemedicine and E-commerce

The rise of telemedicine and e-commerce platforms is redefining distribution channels, enabling easier access to treatments but also intensifying competition. This trend is expected to continue, especially in regions with growing internet penetration and healthcare infrastructure[1][4].

New Formulations and Niche Markets

The FDA's approval of new formulations of Armodafinil aimed at enhancing patient compliance signals potential shifts in therapeutic applications and market dynamics. Emerging challengers like HEC Pharmaceuticals and Vistagen Therapeutics are focusing on novel research approaches and agility in product development, targeting specific niches within the market[4].

Off-Label Uses

Armodafinil is also being explored for off-label uses, such as treating attention deficit hyperactivity disorder (ADHD) and in military settings. These emerging applications highlight avenues for further market expansion[1].

Future Forecast

The Armodafinil market is expected to experience steady growth driven by increasing awareness of sleep disorders and growing demand for cognitive enhancers. However, potential disruptors such as the rise of alternative nootropics and stringent regulatory scrutiny may impact market dynamics. Stakeholders should focus on R&D for new formulations and marketing strategies targeting niche consumer segments, while also monitoring regulatory changes and investing in partnerships to enhance supply chain resilience[1][4].

Key Takeaways

• The Armodafinil market is projected to grow at a CAGR of 4.50% from 2024 to 2031.
• North America, particularly the U.S., is the largest market segment.
• Asia-Pacific and Middle East & Africa regions are also experiencing significant growth.
• Key players include Teva, Mylan, Apotex, and others, with competitive strategies focused on innovation, pricing, and distribution.
• Emerging trends include telemedicine, e-commerce, and new formulations.
• Off-label uses and niche markets offer additional growth opportunities.

FAQs

Q: What is NUVIGIL (Armodafinil) used for?

NUVIGIL (Armodafinil) is used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder.

Q: What is the projected growth rate of the Armodafinil market?

The Armodafinil market is projected to exhibit a CAGR of 4.50% during the forecast period from 2024 to 2031.

Q: Which regions are driving the growth of the Armodafinil market?

North America, particularly the United States, is the largest region, followed by Europe and the Asia-Pacific region.

Q: Who are the key players in the Armodafinil market?

Key players include Teva Pharmaceuticals, Mylan, Apotex, Lupin, Sandoz, Natco Pharma, and Aurobindo.

Q: What are some emerging trends in the Armodafinil market?

Emerging trends include the rise of telemedicine, e-commerce platforms, new formulations, and off-label uses such as treating ADHD and military applications.

Sources

1. Comprehensive Market Forecast for Armodafinil - openPR.com
2. Teva Reports Full Year and Fourth Quarter 2016 Financial Results - Teva Pharmaceuticals
3. NUVIGIL® (armodafinil) Tablets [C-IV] Rx Only - FDA
4. Armodafinil Market Size & Share Analysis - Growth Trends & - openPR.com
5. Teva Reports First Quarter 2017 Financial Results - Teva Pharmaceuticals