METHYLIN Drug Patent Profile

When do Methylin patents expire, and what generic alternatives are available?

Methylin is a drug marketed by Specgx Llc and is included in three NDAs.

The generic ingredient in METHYLIN 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 Methylin

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

Summary for METHYLIN

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	3
Patent Applications:	4,573
Drug Prices:	Drug price information for METHYLIN
What excipients (inactive ingredients) are in METHYLIN?	METHYLIN excipients list
DailyMed Link:	METHYLIN at DailyMed

See drug prices for METHYLIN

See drug sales revenues for METHYLIN

Recent Clinical Trials for METHYLIN

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

Sponsor	Phase
Nicoleta Stoicea	Phase 1
Boston Children’s Hospital	Phase 1
Boston Children's Hospital	Phase 1

See all METHYLIN clinical trials

Pharmacology for METHYLIN

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

Paragraph IV (Patent) Challenges for METHYLIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METHYLIN	Oral Solution	methylphenidate hydrochloride	5 mg/5 mL 10 mg/5 mL	021419	1	2010-04-13

US Patents and Regulatory Information for METHYLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-001	Dec 19, 2002	AA	RX	Yes	Yes
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-002	Dec 19, 2002	AA	RX	Yes	Yes
Specgx Llc	METHYLIN	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	021475-001	Apr 15, 2003		DISCN	Yes	No
Specgx Llc	METHYLIN	methylphenidate hydrochloride	TABLET, CHEWABLE;ORAL	021475-002	Apr 15, 2003		DISCN	Yes	No
Specgx Llc	METHYLIN ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	075629-002	May 9, 2000	AB	RX	No	No

Expired US Patents for METHYLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-001	Dec 19, 2002
Specgx Llc	METHYLIN	methylphenidate hydrochloride	SOLUTION;ORAL	021419-002	Dec 19, 2002

International Patents for METHYLIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004280240	Methylphenidate solution and associated methods of administration and production
China	1867359	Methylphenidate solution and associated methods of administration and produciton
European Patent Office	1680144	SOLUTION DE METHYLPHENIDATE ET PROCEDES ASSOCIES D'ADMINISTRATION ET DE PRODUCTION (METHYLPHENIDATE SOLUTION AND ASSOCIATED METHODS OF ADMINISTRATION AND PRODUCTION)
Spain	2373042
World Intellectual Property Organization (WIPO)	2005035000

Market Dynamics and Financial Trajectory for Methylphenidate (Methylin)

Introduction to Methylphenidate (Methylin)

Methylphenidate, commonly known by the brand name Methylin, is a central nervous system (CNS) stimulant used primarily to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. The drug has been a cornerstone in the management of these conditions for several decades.

Market Size and Growth

The global methylphenidate drug market is experiencing significant growth. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 7.17% from 2021 to 2028. This growth is driven by several key factors, including the increasing prevalence of ADHD, government initiatives to address mental health, and the development of new drugs and formulations[1].

Drivers of Market Growth

Increasing Prevalence of ADHD

The rising number of people suffering from ADHD is a major driver of the methylphenidate market. ADHD affects more than 4.0% of the adult population in the U.S., and this prevalence is expected to continue growing, thereby increasing the demand for methylphenidate and other ADHD medications[1].

Government Support and Initiatives

Governments around the world are increasing their efforts to address mental health issues. For example, in 2016, the U.S. Department of Health & Human Services awarded significant funding to the Substance Abuse and Mental Health Services Administration (SAMHSA) to address serious mental illnesses. Similarly, NHS England implemented a five-year mental health plan with substantial funding, which is expected to boost the market for methylphenidate[1].

Product Launches and R&D Activities

The market is also driven by product launches and increased research and development activities. Pharmaceutical companies are investing in the development of non-stimulant drugs for ADHD, which is further expanding the market segment[1].

Market Segmentation

By Product

The methylphenidate market is segmented into tablets and capsules. The tablet segment dominates the market, with methylphenidate oral tablets being widely used to treat ADHD and narcolepsy[1].

By Application

The market is bifurcated into children (6-17 years) and adults. The adult segment holds the largest share, primarily due to the large patient population. ADHD affects a significant portion of the adult population, making this segment crucial for the market[1].

By Geography

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 volume of drug prescriptions, increasing product launches, and collaborative efforts among market players to enhance market penetration and product development[1].

Financial Aspects

Pricing and Cost

The cost of methylphenidate can vary depending on the formulation and pharmacy. For instance, the cost for Methylin (5 mg/5 mL) oral solution is around $83 for a supply of 500 milliliters. Generic versions are also available, which can be more affordable, with prices starting from $116.60 for 500 milliliters[5].

Revenue and Market Size

The global methylphenidate market is expected to grow significantly, driven by the factors mentioned above. The substantial growth rate indicates a robust financial trajectory for the market, with increasing revenue anticipated over the forecast period.

Competitive Landscape

The methylphenidate market is highly competitive, with several major players involved. Key players include Janssen Pharmaceuticals, NEOS Therapeutics, Rhodes Pharmaceuticals, Noven Therapeutics, Ironshore Pharmaceuticals, Lannett Company, Novartis, Teva, Tris Pharma, Amneal, Impax Laboratories, Mylan, Trigen Laboratories, Sun Pharmaceutical, Oxford Pharm, Novel Laboratories, and Breckenridge Pharmaceutical. These companies are engaged in various strategies such as product launches, collaborations, and investments in R&D to maintain and expand their market share[1].

Challenges and Restraints

Side Effects

One of the significant restraints on the market growth is the side effects associated with methylphenidate. Common side effects include difficulty sleeping, decreased appetite, anxiety, and weight loss. More serious side effects can include psychosis, allergic reactions, prolonged erections, substance abuse, and heart problems. These side effects can deter some patients and healthcare providers from using the drug[1].

Regulatory and Ethical Concerns

There are also regulatory and ethical concerns surrounding the promotion and use of methylphenidate. For example, there have been allegations of pharmaceutical companies influencing patient advocacy groups to promote their drugs. The case of CHADD (Children and Adults with Attention Deficit/Hyperactivity Disorder) receiving significant funding from Ciba-Geigy (now part of Novartis) to promote Ritalin (another methylphenidate brand) highlights these concerns[2].

Role of Pharmaceutical Industry

The pharmaceutical industry plays a crucial role in the promotion and development of methylphenidate. Companies invest heavily in research and marketing, which can sometimes lead to a bias towards medication over alternative therapies. The industry's profit motive drives innovation and product improvement, but it also raises questions about the balance between profit and public health[2].

Future Outlook

The future outlook for the methylphenidate market is positive, driven by increasing awareness of mental health, government support, and ongoing R&D activities. However, the market must navigate the challenges posed by side effects and regulatory concerns.

"The growing prevalence of ADHD disorder and increasing preference for cheaper and effective generic ADHD drugs are expected to boost the Methylphenidate Drug Market over the coming years"[1].

Key Takeaways

• The global methylphenidate market is growing at a CAGR of 7.17% from 2021 to 2028.
• The market is driven by the increasing prevalence of ADHD, government initiatives, and product launches.
• North America dominates the global market, with a significant share.
• The market is segmented into tablets and capsules, with the tablet segment being dominant.
• Side effects and regulatory concerns are key restraints on market growth.
• The pharmaceutical industry plays a significant role in promoting and developing methylphenidate.

FAQs

What is the projected growth rate of the methylphenidate market?

The methylphenidate market is projected to grow at a CAGR of 7.17% from 2021 to 2028.

Which region dominates the global methylphenidate market?

North America dominates the global methylphenidate market, accounting for more than 68.0% of the total market.

What are the common side effects of methylphenidate?

Common side effects include difficulty sleeping, decreased appetite, anxiety, and weight loss. More serious side effects can include psychosis, allergic reactions, prolonged erections, substance abuse, and heart problems.

Which companies are key players in the methylphenidate market?

Key players include Janssen Pharmaceuticals, NEOS Therapeutics, Rhodes Pharmaceuticals, Noven Therapeutics, Ironshore Pharmaceuticals, and several others.

How does government support impact the methylphenidate market?

Government support through initiatives and funding for mental health programs significantly boosts the market by increasing awareness and access to treatments like methylphenidate.

Sources

1. Verified Market Research: Methylphenidate Drug Market Size, Share, Opportunities & Forecast.
2. PBS: The Business Of Adhd | PBS - Medicating Kids | FRONTLINE.
3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
4. BCC Research: Global Methylphenidate Drug Market Size By Product, By Application.
5. Drugs.com: Methylin Prices, Coupons, Copay Cards & Patient Assistance.