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Last Updated: December 22, 2024

ARMODAFINIL Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Armodafinil

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

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Recent Clinical Trials for ARMODAFINIL

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

SponsorPhase
Charles Andrew Czeisler, MD, PhDPhase 4
Jazz PharmaceuticalsPhase 4
University of FloridaPhase 1

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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
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-001 Mar 6, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-004 Sep 28, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Corepharma ARMODAFINIL armodafinil TABLET;ORAL 201514-003 Mar 25, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 206069-003 Mar 6, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Pharms Inc ARMODAFINIL armodafinil TABLET;ORAL 200043-001 Jun 1, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Natco Pharma Ltd ARMODAFINIL armodafinil TABLET;ORAL 202768-005 Sep 28, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd ARMODAFINIL armodafinil TABLET;ORAL 200751-001 Nov 28, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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].

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