ARMODAFINIL - Generic Drug Details

What are the generic sources for armodafinil and what is the scope of freedom to operate?

Armodafinil is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Corepharma, Lupin Ltd, Mylan Pharms Inc, Natco Pharma Ltd, Watson Labs Inc, and Cephalon, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twelve drug master file entries for armodafinil. Twelve suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for ARMODAFINIL

International Patents:	116
US Patents:	2
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	59
Patent Applications:	5,681
Drug Prices:	Drug price trends for ARMODAFINIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARMODAFINIL
What excipients (inactive ingredients) are in ARMODAFINIL?	ARMODAFINIL excipients list
DailyMed Link:	ARMODAFINIL at DailyMed

See drug prices for ARMODAFINIL

Recent Clinical Trials for ARMODAFINIL

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

Sponsor	Phase
Charles Andrew Czeisler, MD, PhD	Phase 4
Jazz Pharmaceuticals	Phase 4
University of Florida	Phase 1

See all ARMODAFINIL clinical trials

Generic filers with tentative approvals for ARMODAFINIL

Applicant	Application No.	Strength	Dosage Form
		50MG	TABLET;ORAL
		250MG	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.

Anatomical Therapeutic Chemical (ATC) Classes for ARMODAFINIL

N06BA	Centrally acting sympathomimetics
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ARMODAFINIL

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 ARMODAFINIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	ARMODAFINIL	armodafinil	TABLET;ORAL	200043-005	May 9, 2019	AB	RX	No	No
Mylan Pharms Inc	ARMODAFINIL	armodafinil	TABLET;ORAL	200043-002	Jun 1, 2012	AB	RX	No	No
Aurobindo Pharma Ltd	ARMODAFINIL	armodafinil	TABLET;ORAL	206069-003	Mar 6, 2018	AB	RX	No	No
Natco Pharma Ltd	ARMODAFINIL	armodafinil	TABLET;ORAL	202768-003	Nov 28, 2016	AB	RX	No	No
Mylan Pharms Inc	ARMODAFINIL	armodafinil	TABLET;ORAL	200043-004	May 9, 2019	AB	RX	No	No
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009		DISCN	Yes	No	7,132,570*PED

Expired US Patents for ARMODAFINIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009	7,132,570*PED
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	4,927,855*PED
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	4,927,855*PED
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-005	Mar 26, 2009	4,927,855*PED
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009	4,927,855*PED
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	7,132,570*PED

International Patents for ARMODAFINIL

Country	Patent Number	Title	Estimated Expiration
Norway	20035211
World Intellectual Property Organization (WIPO)	2004024133
Cyprus	1109465
Argentina	041242	FORMULACIONES FARMACEUTICAS DE MODAFINIL Y PROCESOS PARA SU PREPARACION
Taiwan	200419175	Process for the preparation of and crystalline forms of optical enantiomers of modafinil
South Africa	200504805	Method for the procution of crystalline forms and crystalline forms of optical enantiomers of modafinil

ARMODAFINIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Armodafinil

Introduction to Armodafinil

Armodafinil, marketed under the trade name Nuvigil, is a wakefulness-promoting agent used primarily to treat narcolepsy, obstructive sleep apnea, and shift work sleep disorder. It is the enantiopure compound of the racemic modafinil, consisting only of the (R)-(−)-enantiomer[4].

Market Size and Growth

The global Armodafinil market has been experiencing steady growth, driven by several key factors. As of 2023, the global Armodafinil market size was significant, and it is projected to grow at a compound annual growth rate (CAGR) of 4.50% from 2024 to 2031[2].

• Global Market: The market is expected to exhibit robust growth, driven by the expanding patient population, particularly among shift workers and individuals with lifestyle-induced fatigue.
• Regional Markets:
  • North America: Valued at approximately $1.5 billion, the North American market is growing at a CAGR of 7%, driven by a well-established healthcare infrastructure and rising awareness of sleep apnea[2].
  • Asia-Pacific: Projected to reach $500 million, this region is growing at a robust 10% CAGR, driven by rising awareness of sleep disorders and cognitive enhancement in developed regions like Japan and Australia[2].
  • Latin America: Valued at around $250 million, the Latin American market is growing at an 8% CAGR, driven by a growing recognition of sleep disorders and increasing demand for cognitive performance enhancement among young professionals[2].
  • Middle East & Africa: Estimated at $150 million, this region is growing at a rate of 9% CAGR, influenced by increasing awareness of mental health and sleep disorders in urban areas[2].

Key Drivers of Market Growth

Several factors are driving the growth of the Armodafinil market:

• Increasing Awareness of Sleep Disorders: Rising awareness and diagnosis of sleep disorders such as narcolepsy, obstructive sleep apnea, and shift work sleep disorder are key drivers[2][4].
• Cognitive Enhancement: The growing trend of cognitive enhancement in professional environments has led to a wider acceptance of Armodafinil[2].
• Product Innovation and Strategic Collaborations: Pharmaceutical companies are focusing on product innovation and strategic collaborations, which are further fueling market expansion[2].
• Generic Versions: The advent of generic versions of Armodafinil is making the drug more accessible and cost-effective, positively influencing market dynamics[2][5].

Competitive Landscape

The Armodafinil market is characterized by a few key players:

• Teva Pharmaceuticals: A leading player in the generic drug market, Teva boasts a strong portfolio that includes Armodafinil, with a significant revenue stream from its generic products[2].
• Mylan (Viatris): Mylan has expanded its offerings in central nervous system medications, including Armodafinil, and reported revenue of approximately $11.9 billion in 2020[2].
• Apotex: Known for its commitment to quality and compliance, Apotex has seen steady market growth in the Armodafinil segment[2].
• Lupin Pharmaceuticals: Leveraging its research capabilities and manufacturing expertise, Lupin has made significant inroads into the Armodafinil market[2].

Other notable players include Cephalon, Dr. Reddy's Laboratories, Cipla Limited, Sun Pharmaceutical Industries, and several others[4].

Market Segmentation

The Armodafinil market is segmented based on several criteria:

• By Application: Narcolepsy, obstructive sleep apnea/hypopnea syndrome, shift work sleep disorder, and other applications[4].
• By Route of Administration: Primarily oral[4].
• By Dosage Form: Tablets are the most common dosage form[5].
• By Distribution Channel: Hospital pharmacies, retail pharmacies, and online pharmacies[4].

Financial Trajectory

The financial trajectory of the Armodafinil market is promising, with several indicators of growth:

• Revenue Growth: The market is expected to grow significantly, with a projected CAGR of 4.50% from 2024 to 2031[2].
• Regional Revenue: North America, Asia-Pacific, Latin America, and the Middle East & Africa are all expected to contribute substantially to the global revenue[2].
• Government Expenditure: The listing of Armodafinil on the Pharmaceutical Benefits Scheme (PBS) has increased government expenditure for PBS-subsidised narcolepsy therapy, indicating a higher market value[3].

Challenges and Opportunities

Despite the growth, the market faces some challenges:

• Regulatory Policies: Strict regulatory policies can hamper market growth[4].
• Adverse Effects: Common adverse effects such as headache, insomnia, nausea, skin rash, anxiety, and xerostomia may deter some patients[5].

However, there are also significant opportunities:

• Telemedicine and Personalized Medicine: Emerging trends in telemedicine and personalized medicine offer new avenues for market expansion[2].
• E-commerce Platforms: The surge in e-commerce platforms for medicine distribution presents significant market opportunities, especially in regions like Asia-Pacific[2].
• Mental Health Awareness: Increasing mental health awareness, particularly in urban areas of the Middle East and Africa, is expected to drive demand[2].

Key Takeaways

• The Armodafinil market is growing steadily due to increasing awareness of sleep disorders and the demand for cognitive enhancement.
• Key players like Teva, Mylan, and Lupin are driving market growth through product innovation and strategic collaborations.
• Generic versions of Armodafinil are making the drug more accessible and cost-effective.
• Regional markets, especially in North America and Asia-Pacific, are expected to contribute significantly to global revenue.
• Despite challenges, emerging trends in telemedicine, e-commerce, and mental health awareness present substantial market opportunities.

FAQs

1. What is Armodafinil used for?

   • Armodafinil is used primarily to treat narcolepsy, obstructive sleep apnea, and shift work sleep disorder, enhancing alertness in adult patients with excessive sleepiness[5].

2. Who are the key players in the Armodafinil market?

   • Key players include Teva Pharmaceuticals, Mylan (Viatris), Apotex, Lupin Pharmaceuticals, and several other generic and pharmaceutical companies[2][4].

3. What is the projected CAGR of the Armodafinil market from 2024 to 2031?

   • The Armodafinil market is projected to exhibit a robust CAGR of 4.50% during the forecast period from 2024 to 2031[2].

4. How does the availability of generic versions impact the Armodafinil market?

   • The advent of generic versions makes Armodafinil more accessible and cost-effective, positively influencing market dynamics and growth[2][5].

5. What are some emerging trends in the Armodafinil market?

   • Emerging trends include the rise of telemedicine, personalized medicine, and e-commerce platforms for medicine distribution, as well as increasing mental health awareness[2].