Methylphenidate - Generic Drug Details

What are the generic drug sources for methylphenidate and what is the scope of patent protection?

Methylphenidate is the generic ingredient in eighteen branded drugs marketed by Noven Pharms Inc, Mylan Tech Viatris, Neos Theraps Inc, Actavis Elizabeth, Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Aytu Biopharma, Barr Labs Inc, Dr Reddys Labs Sa, Granules, Impax Labs Inc, Specgx Llc, Teva Pharms, Sandoz, Actavis Labs Fl Inc, Nextwave, Abhai Llc, Alkem Labs Ltd, Anda Repository, Ascent Pharms Inc, Breckenridge, Chartwell Molecular, Novel Labs Inc, Quagen, Tris Pharma Inc, Wes Pharma Inc, Nostrum Labs Inc, Rising, Nextwave Pharms, Janssen Pharms, Lannett Co Inc, Able, Actavis Labs Fl, Alvogen, Amneal Pharms, Andor Pharms, Ani Pharms, Aurolife Pharma Llc, Dr Reddys, Heritage Pharma, Osmotica Pharm Us, Strides Pharma, Sun Pharm Inds Inc, Watson Labs, Novartis, Abhai Inc, Accord Hlthcare, Bionpharma, Cediprof Inc, Mountain, Oxford Pharms, and Prinston Inc, and is included in eighty-nine NDAs. There are fifty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Methylphenidate has nine patent family members in five countries.

There are thirty-two drug master file entries for methylphenidate. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for methylphenidate

International Patents:	9
US Patents:	52
Tradenames:	18
Applicants:	53
NDAs:	89
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	418
Patent Applications:	6,694
Drug Prices:	Drug price trends 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
Institute of Medical Sciences of the University of Opole	Phase 2
Medical University of Silesia	Phase 2

See all methylphenidate clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE

Applicant	Application No.	Strength	Dosage Form
		40MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
		30MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL
		20MG	TABLET, EXTENDED RELEASE, CHEWABLE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-003	Jun 23, 2022		RX	Yes	No
Specgx Llc	METHYLIN ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075629-001	May 9, 2000	AB	RX	No	No
Barr Labs Inc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	079031-001	Jul 13, 2012		DISCN	No	No
Watson Labs	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	040220-001	Aug 29, 1997		DISCN	No	No
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-001	Aug 8, 2018		RX	Yes	No	11,911,518
Specgx Llc	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202608-002	Dec 28, 2012	BX	RX	No	No

Expired US Patents for methylphenidate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-002	Apr 6, 2006	5,958,446
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-001	Apr 6, 2006	5,958,446
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	5,958,446
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	6,210,705
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-003	Apr 6, 2006	6,210,705
Noven Pharms Inc	DAYTRANA	methylphenidate	FILM, EXTENDED RELEASE;TRANSDERMAL	021514-004	Apr 6, 2006	5,958,446

International Patents for methylphenidate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)
Japan	2020504763	メチルフェニデートを用いてＡＤＨＤを処置するための小児の有効な投薬
Australia	2017353921	Effective dosing of a child for the treatment of ADHD with methylphenidate
South Korea	20240033130	ADHD의 치료를 위한 메틸페니데이트의 효과적인 아동 투여 (ADHD EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)
World Intellectual Property Organization (WIPO)	2006041911
European Patent Office	3585439	DOSAGE EFFICACE D'UN ENFANT POUR LE TRAITEMENT DU TDAH AVEC DU MÉTHYLPHÉNIDATE (EFFECTIVE DOSING OF A CHILD FOR THE TREATMENT OF ADHD WITH METHYLPHENIDATE)

Methylphenidate Market Analysis and Financial Projection Experimental

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.