METHYLPHENIDATE Drug Patent Profile

When do Methylphenidate patents expire, and when can generic versions of Methylphenidate launch?

Methylphenidate is a drug marketed by Mylan Tech Viatris, Actavis Elizabeth, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Actavis Labs Fl Inc, Abhai Llc, Alkem Labs Ltd, Allied, Anda Repository, Ascent Pharms Inc, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Lannett Co Inc, Osmotica Pharm Us, Rhodes Pharms, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc. and is included in seventy-one NDAs.

The generic ingredient in METHYLPHENIDATE is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Methylphenidate

A generic version of METHYLPHENIDATE was approved as methylphenidate hydrochloride by SPECGX LLC on November 27^th, 1998.

Summary for METHYLPHENIDATE

US Patents:	0
Applicants:	43
NDAs:	71
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	418
Patent Applications:	5,033
Drug Prices:	Drug price information for METHYLPHENIDATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METHYLPHENIDATE
What excipients (inactive ingredients) are in METHYLPHENIDATE?	METHYLPHENIDATE excipients list
DailyMed Link:	METHYLPHENIDATE at DailyMed

See drug prices for METHYLPHENIDATE

See drug sales revenues for METHYLPHENIDATE

Recent Clinical Trials for METHYLPHENIDATE

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

Sponsor	Phase
University of Florida	Early Phase 1
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz	Phase 2
Institute of Medical Sciences of the University of Opole	Phase 2

See all METHYLPHENIDATE clinical trials

Pharmacology for METHYLPHENIDATE

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for METHYLPHENIDATE

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METHYLPHENIDATE

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

Paragraph IV (Patent) Challenges for METHYLPHENIDATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COTEMPLA XR-ODT	Extended-release Orally Disintegrating Tablets	methylphenidate	8.6 mg, 17.3 mg and 25.9 mg	205489	1	2017-09-01
DAYTRANA	Transdermal System	methylphenidate	10 mg/9 hrs 15 mg/9 hrs 20 mg/9 hrs 30 mg/9 hrs	021514	1	2011-04-13

US Patents and Regulatory Information for METHYLPHENIDATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	077707-001	Jul 19, 2012	AB2	RX	No	No
Nostrum Labs Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	204954-002	Jan 26, 2017		DISCN	No	No
Amneal Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	207515-003	Feb 1, 2018		DISCN	No	No

Methylphenidate Market Dynamics and Financial Trajectory

Introduction to Methylphenidate

Methylphenidate, a central nervous system stimulant, is widely used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Its effectiveness in enhancing focus, behavior, and cognitive function has made it a crucial medication in the mental health sector.

Market Size and Growth

The methylphenidate market is experiencing significant growth driven by several key factors:

• Current Market Size: The methylphenidate market was valued at USD 6.3 billion in 2023 and is projected to reach USD 7.7 billion by 2031, growing at a CAGR of 10.8% from 2024 to 2031[5].
• Alternative Projections: Another report indicates a slightly lower but still robust growth, with the market valued at USD 1.5 billion in 2023 and expected to reach USD 2.3 billion by 2031, growing at a CAGR of 4.33% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of ADHD

The rising awareness and diagnosis of ADHD among children and adults are significant drivers of the methylphenidate market. As more cases are identified, the demand for medications like methylphenidate increases[5].

Improved Awareness and Education

Increased awareness about ADHD and its treatment options among parents, healthcare providers, and the general public encourages more diagnoses and subsequent prescriptions of methylphenidate. This heightened awareness reduces the stigma associated with mental health treatments, further boosting market growth[5].

Pharmaceutical Advancements

Ongoing research and development in formulations, such as extended-release and sustained-release versions of methylphenidate, can expand its appeal and usage. These advancements improve patient compliance and therapeutic efficacy, driving market growth[5].

Government Initiatives and Policies

Government initiatives, such as the U.S. Department of Health & Human Services awarding funds to address serious mental illnesses, support the market by increasing access to mental health treatments. Regulatory approvals for new formulations or combination therapies involving methylphenidate also contribute to market expansion[3].

Rising Healthcare Expenditure

Increased spending on healthcare, particularly in developed countries, allows greater access to medications for managing ADHD and other related disorders. This increased expenditure is a significant factor in the growing demand for methylphenidate[5].

Geographical Market Dynamics

North America

North America dominates the global methylphenidate market, accounting for more than 68.0% of the total market in 2018. This dominance is attributed to the high prevalence rates of ADHD diagnoses and the robust healthcare infrastructure in the region[3].

Europe

Europe follows closely, with various countries having established guidelines and practices concerning ADHD treatment. Regulatory policies may affect market dynamics differently across Western and Eastern European nations[5].

Asia-Pacific and Other Regions

The Asia-Pacific region and other emerging markets are beginning to recognize ADHD as a significant issue, driving demand for methylphenidate and related therapeutics. This growing recognition in emerging markets is expected to contribute significantly to the global market growth[5].

Product Segmentation

The methylphenidate market is segmented based on various product forms and applications:

• Product Forms: Tablets, extended-release tablets, oral solutions, and capsules[1].
• Applications: ADHD treatment, narcolepsy management, cognitive function enhancement, and clinical research[1].

Competitive Landscape

The methylphenidate market is characterized by a competitive landscape with several major players:

• Novartis Pharmaceuticals
• Teva Pharmaceuticals
• Janssen Pharmaceuticals (Johnson & Johnson)
• Reddy’s Laboratories
• Mylan N.V.
• Amgen Inc.
• AstraZeneca PLC
• Shionogi & Co. Ltd.
• Sandoz (a Novartis division)
• Sun Pharmaceutical Industries Ltd.[5]

These companies are involved in continuous research and development, product launches, and strategic collaborations to enhance market penetration and product development.

Regulatory and Policy Influences

Regulatory approvals and government policies play a crucial role in shaping the methylphenidate market. Fast-tracked regulatory approvals for new formulations or combination therapies involving methylphenidate can lead to growth in its market share and accessibility. Additionally, government initiatives aimed at addressing mental health issues support the market by increasing funding and resources for mental health treatments[3].

Patient Adherence and Treatment Options

Improvements in medication administration methods, such as formulations with prolonged release, improve patient compliance and therapeutic efficacy. The availability of other therapeutic options, including behavioral therapies and alternative medications, can also impact the market by increasing overall awareness and treatment options for ADHD and related disorders[1].

Adverse Events and Safety

While methylphenidate is generally well-tolerated, studies have reported mild to moderate adverse events, such as headaches, feelings of blood rushing to the head, and contractions in the head. However, these symptoms are typically self-limiting and do not lead to withdrawal from treatment[2].

Research and Development

Ongoing research into new formulations and expanded indications continues to drive innovation and market expansion. Studies exploring the efficacy of methylphenidate in conditions such as mild cognitive impairment and brain tumor survivorship suggest potential new avenues for its use[2][4].

Key Takeaways

• The methylphenidate market is projected to grow significantly, driven by increasing ADHD prevalence, improved awareness, and pharmaceutical advancements.
• North America dominates the global market due to high ADHD prevalence rates and robust healthcare infrastructure.
• Regulatory approvals and government initiatives support market growth by increasing access to mental health treatments.
• Continuous research and development are crucial for expanding the market and improving treatment options.
• The competitive landscape is characterized by major pharmaceutical companies investing in new formulations and market expansion.

FAQs

Q: What is the current market size of the methylphenidate market?

The methylphenidate market was valued at USD 6.3 billion in 2023[5].

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

The market is projected to grow at a CAGR of 10.8% from 2024 to 2031[5].

Q: Which region dominates the global methylphenidate market?

North America dominates the global methylphenidate market, accounting for more than 68.0% of the total market in 2018[3].

Q: What are the main drivers of the methylphenidate market growth?

Key drivers include increasing ADHD prevalence, improved awareness and education, pharmaceutical advancements, and rising healthcare expenditure[5].

Q: Are there any potential new uses for methylphenidate being researched?

Yes, ongoing research is exploring the efficacy of methylphenidate in conditions such as mild cognitive impairment and brain tumor survivorship[2][4].

Sources

1. Market Research Intellect: Methylphenidate Market Size, Growth & Analysis Report 2024-2031.
2. Frontiers in Medicine: Methylphenidate for Mild Cognitive Impairment: An Exploratory 3-Day Randomized Controlled Trial.
3. Verified Market Research: Methylphenidate Drug Market Size, Share, Opportunities & Forecast.
4. MDPI: Key Questions on the Long-Term Utility of Methylphenidate in Brain Tumor Survivorship.
5. Verified Market Research: Methylphenidate Market Size, Share, Scope, Trends & Forecast.