Methylphenidate hydrochloride - Generic Drug Details

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

Methylphenidate hydrochloride is the generic ingredient in fifteen branded drugs marketed by Purdue Pharma Lp, Rhodes Pharms, Ironshore Pharms, Aytu Biopharma, Actavis Elizabeth, 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-five NDAs. There are forty-five patents protecting this compound and twelve Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylphenidate hydrochloride has one hundred and twenty-one patent family members in twenty-two countries.

There are twenty-three drug master file entries for methylphenidate hydrochloride. Forty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for methylphenidate hydrochloride

International Patents:	121
US Patents:	45
Tradenames:	15
Applicants:	50
NDAs:	85
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	418
Patent Applications:	4,944
Drug Prices:	Drug price trends for methylphenidate hydrochloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for methylphenidate hydrochloride
What excipients (inactive ingredients) are in methylphenidate hydrochloride?	methylphenidate hydrochloride excipients list
DailyMed Link:	methylphenidate hydrochloride at DailyMed

See drug prices for methylphenidate hydrochloride

Recent Clinical Trials for methylphenidate hydrochloride

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 hydrochloride clinical trials

Generic filers with tentative approvals for METHYLPHENIDATE HYDROCHLORIDE

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

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

Anatomical Therapeutic Chemical (ATC) Classes for methylphenidate hydrochloride

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

Paragraph IV (Patent) Challenges for METHYLPHENIDATE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QUILLICHEW ER	Extended-release Chewable Tablets	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	207960	1	2016-04-25
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	30 mg	205831	1	2016-03-28
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	15 mg, 20 mg, 40 mg and 50 mg	205831	1	2015-12-28
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	10 mg	205831	1	2015-12-24
APTENSIO XR	Extended-release Capsules	methylphenidate hydrochloride	60 mg	205831	1	2015-12-23
QUILLIVANT XR	Extended-release Oral Suspension	methylphenidate hydrochloride	5 mg/mL	202100		2013-08-02
METHYLIN	Oral Solution	methylphenidate hydrochloride	5 mg/5 mL 10 mg/5 mL	021419	1	2010-04-13
RITALIN LA	Extended-release Capsules	methylphenidate hydrochloride	10 mg	021284	1	2007-05-21
METADATE CD	Extended-release Capsules	methylphenidate hydrochloride	40 mg	021259	1	2007-03-15
RITALIN LA	Extended-release Capsules	methylphenidate hydrochloride	20 mg, 30 mg and 40 mg	021284		2006-08-21
CONCERTA	Extended-release Tablets	methylphenidate hydrochloride	18 mg*, 27 mg, 36 mg and 54 mg	021121		2005-07-19
METADATE CD	Extended-release Capsules	methylphenidate hydrochloride	10 mg, 20 mg and 30 mg	021259	1	2005-05-13

US Patents and Regulatory Information for methylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bionpharma	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	209753-003	Mar 2, 2018	AB	RX	No	No
Ani Pharms	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208607-004	Jul 14, 2017		DISCN	No	No
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002	AB1	RX	Yes	No
Ironshore Pharms	JORNAY PM	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	209311-003	Aug 8, 2018		RX	Yes	No
Alkem Labs Ltd	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET;ORAL	211779-003	Oct 4, 2019	AB	RX	No	No
Lannett Co Inc	METADATE ER	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	089601-001	Jun 1, 1988		DISCN	No	No
Actavis Elizabeth	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208861-001	Dec 13, 2018	AB3	RX	No	No

Expired US Patents for methylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-003	Jun 5, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-002	Jun 19, 2003
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002

International Patents for methylphenidate hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2880456	COMPRIME A CROQUER DE METHYLPHENIDATE A LIBERATION MODIFIEE (METHYLPHENIDATE EXTENDED RELEASE CHEWABLE TABLET)
South Korea	20170115036	특히 주의력 결핍 장애의 치료를 위한 방법 및 조성물 (METHODS AND COMPOSITIONS PARTICULARLY FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
Russian Federation	2435569	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)
World Intellectual Property Organization (WIPO)	2012112140
Japan	2018197276	注意欠陥障害の処置のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)
Spain	2644942
Japan	2016117767	注意欠陥障害の処置のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF ATTENTION DEFICIT DISORDER)

Methylphenidate hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methylphenidate Hydrochloride

Market Overview

Methylphenidate hydrochloride, a medication primarily used to treat attention-deficit/hyperactivity disorder (ADHD), is experiencing significant growth in the global market. Here are the key dynamics and financial projections for this drug.

Market Size and Growth

The methylphenidate hydrochloride market has been expanding rapidly. As of 2023, the market size was valued at approximately USD 101 million and is projected to reach USD 153.2 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.0% during the forecast period from 2024 to 2030[4].

Segmentation

The market is segmented based on several factors:

Type

The market is categorized into different purity levels, such as 99% purity and other types. This segmentation helps in understanding the demand for different grades of methylphenidate hydrochloride[1].

Application

The primary application of methylphenidate hydrochloride is in the treatment of ADHD. However, it can also be used for other conditions, which are included in the "other" category. The market is bifurcated into children (6-17 years) and adults, with the adult segment holding a significant share due to a larger patient population[3].

Geography

The global market is divided into regions such as North America, Europe, Asia-Pacific, and the rest of the world. North America dominates the market, accounting for more than 68% of the total market share in 2018, driven by high prescription volumes and collaborative efforts among market players[3].

Drivers of Growth

Several factors are driving the growth of the methylphenidate hydrochloride market:

Increasing Prevalence of ADHD

The rising number of people suffering from ADHD is a significant driver. Governments worldwide are taking steps to address mental health issues, including ADHD, which is boosting the market[3].

Government Support and Awareness

Government initiatives, such as the U.S. Department of Health & Human Services' funding for mental health services and NHS England's mental health plan, are increasing awareness and support for ADHD treatment. This has led to increased investment in mental health care, benefiting the methylphenidate hydrochloride market[3].

Product Launches and R&D

Continuous product launches and increased research and development activities by pharmaceutical companies are also driving market growth. The development of non-stimulant drugs for ADHD is further expanding the market[3].

Restraints and Challenges

Despite the growth, there are several challenges facing the methylphenidate hydrochloride market:

Side Effects

Common side effects such as difficulty sleeping, decreased appetite, anxiety, and weight loss, along with more serious side effects like psychosis, allergic reactions, and heart problems, are significant restraints. These side effects can deter some patients and healthcare providers from using the drug[3].

Long-term Effects

There is ongoing concern about the long-term effects of methylphenidate on the developing brain, particularly in children. Studies have shown age-dependent effects of methylphenidate on dopamine function, which can be a concern for long-term use[2].

Key Players

The market is dominated by several key players:

• Janssen Pharmaceuticals
• Novartis Pharmaceuticals
• China Resources Shuanghe Pharmaceutical
• Suzhou First Pharmaceutical
• Tonghua Renmin Pharmaceutical

These companies are investing heavily in research and development, product launches, and market penetration strategies[4].

Financial Projections

The financial trajectory of the methylphenidate hydrochloride market is promising:

• Market Size in 2023: USD 101 million
• Projected Market Size in 2030: USD 153.2 million
• CAGR from 2024 to 2030: 6.0%[4]

Regional Analysis

North America is the leading region in the methylphenidate hydrochloride market, driven by high prescription rates and collaborative efforts among pharmaceutical companies. Europe and Asia-Pacific regions are also significant, with growing awareness and government support for mental health care[3].

Impact of Research and Development

Research on methylphenidate hydrochloride continues to uncover its effects on the brain and body. For instance, studies have shown that methylphenidate can increase extracellular dopamine levels and affect cerebral blood flow, particularly in children. These findings are crucial for understanding the drug's efficacy and safety profile[2].

"Methylphenidate increases extracellular dopamine (DA) levels in the brain by blocking the DA transporters in the synapse. Its short-term safety has been documented in many studies, and its efficacy is among the highest of all psychiatric medications."[2]

Future Outlook

The future outlook for the methylphenidate hydrochloride market is positive, driven by increasing demand for effective ADHD treatments, government support, and ongoing research and development. However, addressing the concerns about side effects and long-term impacts will be crucial for sustained growth.

Key Takeaways

• The methylphenidate hydrochloride market is expected to grow at a CAGR of 6.0% from 2024 to 2030.
• The market is driven by the increasing prevalence of ADHD, government support, and ongoing R&D activities.
• North America dominates the market, with significant contributions from Europe and Asia-Pacific.
• Key players include Janssen Pharmaceuticals, Novartis Pharmaceuticals, and others.
• Side effects and long-term impacts are significant restraints that need to be addressed.

FAQs

1. What is the primary use of methylphenidate hydrochloride?

Methylphenidate hydrochloride is primarily used to treat attention-deficit/hyperactivity disorder (ADHD).

2. What is the projected market size of methylphenidate hydrochloride by 2030?

The market is projected to reach USD 153.2 million by 2030[4].

3. What are the main drivers of the methylphenidate hydrochloride market?

The main drivers include the increasing prevalence of ADHD, government support, and ongoing research and development activities[3].

4. Which region dominates the methylphenidate hydrochloride market?

North America dominates the market, accounting for more than 68% of the total market share in 2018[3].

5. What are some of the common side effects of methylphenidate hydrochloride?

Common side effects include difficulty sleeping, decreased appetite, anxiety, and weight loss. More serious side effects may include psychosis, allergic reactions, and heart problems[3].

Sources:

1. Market Research Intellect: Methylphenidate Hydrochloride Market Size, Scope And Forecast.
2. JAMA Network: Age-Dependent Effects of Methylphenidate on the Human.
3. Verified Market Research: Methylphenidate Drug Market Size, Share, Opportunities & Forecast.
4. Valuates Reports: Global Methylphenidate HCl Market Research Report 2024.
5. MDPI: Methylphenidate Promotes Premature Growth Plate Closure: In Vitro Evidence.