Dexmethylphenidate hydrochloride - Generic Drug Details

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

Dexmethylphenidate hydrochloride is the generic ingredient in four branded drugs marketed by Adare Pharms Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Endo Operations, Granules, Impax Labs Inc, Medicap Labs, Sun Pharm Inds Inc, Teva Pharms Usa, Sandoz, Abhai Inc, Alkem Labs Ltd, Bionpharma, Cediprof Inc, Lannett Co Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Industries, Teva Pharms, Tris Pharma Inc, and Commave Therap, and is included in twenty-five NDAs. There are six patents protecting this compound and eight Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for dexmethylphenidate hydrochloride. Nineteen suppliers are listed for this compound.

Summary for dexmethylphenidate hydrochloride

US Patents:	6
Tradenames:	4
Applicants:	21
NDAs:	25
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	18
Patent Applications:	4,243
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dexmethylphenidate hydrochloride
What excipients (inactive ingredients) are in dexmethylphenidate hydrochloride?	dexmethylphenidate hydrochloride excipients list
DailyMed Link:	dexmethylphenidate hydrochloride at DailyMed

Recent Clinical Trials for dexmethylphenidate hydrochloride

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

Sponsor	Phase
NYU Langone Health	Phase 4
Prometrika, LLC	Phase 4
Premier Research Group plc	Phase 4

See all dexmethylphenidate hydrochloride clinical trials

Pharmacology for dexmethylphenidate hydrochloride

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

Medical Subject Heading (MeSH) Categories for dexmethylphenidate hydrochloride

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dexmethylphenidate hydrochloride

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

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

Paragraph IV (Patent) Challenges for DEXMETHYLPHENIDATE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	25 mg	021802	1	2011-09-30
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	35 mg	021802	1	2011-09-29
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	40 mg	021802	1	2010-12-20
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	30 mg	021802	1	2010-12-15
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	15 mg	021802	1	2007-05-14
FOCALIN XR	Extended-release Capsules	dexmethylphenidate hydrochloride	5 mg, 10 mg and 20 mg	021802	1	2007-03-30
FOCALIN	Tablets	dexmethylphenidate hydrochloride	2.5 mg	021278	1	2004-07-27
FOCALIN	Tablets	dexmethylphenidate hydrochloride	5 mg and 10 mg	021278	1	2004-05-27

US Patents and Regulatory Information for dexmethylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078908-004	May 19, 2014	AB	RX	No	No
Medicap Labs	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078992-006	Nov 23, 2021	AB	RX	No	No
Granules	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	213813-003	Sep 9, 2020	AB	RX	No	No
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-005	Oct 23, 2009	AB	RX	Yes	No
Endo Operations	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202842-004	Nov 30, 2016	AB	RX	No	No
Endo Operations	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202842-003	Nov 30, 2016	AB	RX	No	No

Expired US Patents for dexmethylphenidate hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-002	Nov 13, 2001
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-008	Apr 21, 2011
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-004	Aug 1, 2006
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-002	May 26, 2005
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-006	Aug 11, 2010
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-006	Aug 11, 2010

Market Dynamics and Financial Trajectory for Dexmethylphenidate Hydrochloride

Introduction to Dexmethylphenidate Hydrochloride

Dexmethylphenidate hydrochloride, commonly known by the brand name Focalin XR, is a central nervous system (CNS) stimulant used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. This medication is part of the broader ADHD therapeutics market, which is experiencing significant dynamics and growth.

ADHD Market Overview

The ADHD treatment market is a substantial and growing sector within the pharmaceutical industry. As of 2022, the global ADHD therapeutics market was valued at approximately $28.6 billion and is projected to reach $64.7 billion by 2030, growing at a CAGR of 10.8% during this period[4].

Market Segmentation by Drug Type

Dexmethylphenidate hydrochloride falls under the category of stimulants, specifically methylphenidates, which are among the most commonly prescribed and effective treatments for ADHD. Stimulants, including amphetamines, methylphenidates, dextroamphetamine, and dexmethylphenidate, dominate the market due to their proven efficacy in managing ADHD symptoms[3][4].

Regional Market Analysis

The ADHD therapeutics market is predominantly driven by regions such as North America, particularly the United States, which held the largest market share in 2022. The high prevalence of ADHD in the U.S., along with favorable reimbursement policies and increased awareness, contributes significantly to the market growth in this region[4].

Financial Performance and Projections

Current Market Size and Growth

The ADHD market, which includes dexmethylphenidate hydrochloride, was valued at $11.9 billion in the seven major markets (7MM) in 2022. However, this specific segment is expected to decline at a CAGR of less than 1% from 2022 to 2032, primarily due to patent expirations and generic competition[1].

Broader Market Growth

Despite the decline in the 7MM segment, the global ADHD therapeutics market is expected to grow significantly. The market is anticipated to reach $64.7 billion by 2030, driven by the increasing prevalence of ADHD, new drug approvals, and improved patient affordability[4].

Key Trends and Developments

New Drug Approvals

Recent approvals, such as the FDA's approval of Tris Pharma’s Onyda XR (clonidine hydrochloride) in May 2024, indicate a trend towards innovative and more convenient treatment options. These approvals are expected to propel market growth by offering patients more choices and improving treatment outcomes[3].

Increasing Awareness and Diagnoses

The rising incidence of ADHD diagnoses, fueled by increased awareness and better diagnostic tools, is a significant driver of market growth. This trend is expected to continue, contributing to the overall expansion of the ADHD therapeutics market[3].

Distribution and Pricing

Distribution Channels

The ADHD therapeutics market, including dexmethylphenidate hydrochloride, is distributed through various channels such as hospital pharmacies, retail pharmacies, and e-commerce platforms. Hospital pharmacies held the largest market share in 2022 and are expected to continue growing at a high CAGR[4].

Pricing and Cost Considerations

The cost of dexmethylphenidate hydrochloride varies based on dosage and formulation. For example, the extended-release formulation (Focalin XR) has a daily dosing cost ranging from $2.97 to $5.73 depending on the dosage strength[5].

Competitive Landscape

The ADHD therapeutics market is competitive, with several key sponsors and manufacturers. Companies like Cingulate Inc., Axsome Therapeutics Inc., Otsuka Pharmaceutical Co. Ltd., and Neurocentria Inc. are prominent players in this market. These companies are involved in various stages of drug development and commercialization, contributing to the market's dynamic nature[1].

Side Effects and Safety Considerations

Dexmethylphenidate hydrochloride, like other ADHD medications, comes with potential side effects. Common side effects include motor and vocal tics, anorexia, insomnia, and anxiety. These side effects can impact patient compliance and may influence market dynamics as patients and healthcare providers seek alternative treatments with better safety profiles[5].

Key Takeaways

• Market Growth: Despite a decline in the 7MM segment, the global ADHD therapeutics market is expected to grow significantly, driven by increasing prevalence and new drug approvals.
• Regional Dominance: North America, particularly the U.S., dominates the market due to high ADHD prevalence and favorable reimbursement policies.
• Drug Type: Stimulants, including dexmethylphenidate hydrochloride, are the most effective and widely prescribed treatments for ADHD.
• Distribution: Hospital pharmacies are the primary distribution channels, with a growing presence of e-commerce platforms.
• Competitive Landscape: The market is highly competitive with several key sponsors and manufacturers involved in drug development and commercialization.

Frequently Asked Questions (FAQs)

1. What is the current market size of the ADHD therapeutics market? The ADHD therapeutics market was valued at approximately $28.6 billion in 2022[4].

2. What is the projected growth rate of the ADHD therapeutics market? The market is expected to grow at a CAGR of 10.8% from 2022 to 2030[4].

3. Which region dominates the ADHD therapeutics market? North America, particularly the United States, holds the largest market share[4].

4. What are the common side effects of dexmethylphenidate hydrochloride? Common side effects include motor and vocal tics, anorexia, insomnia, and anxiety[5].

5. What is the significance of recent drug approvals in the ADHD market? Recent approvals, such as Onyda XR, offer innovative treatment options and are expected to propel market growth by improving treatment outcomes and patient compliance[3].

Cited Sources

1. GlobalData, "Attention Deficit Hyperactivity Disorder (ADHD) Market Opportunity Analysis and Forecasts to 2032".
2. Patsnap, "Dexmethylphenidate Hydrochloride - Drug Targets, Indications, and Phase 3 Clinical Trials".
3. Expert Market Research, "Attention Deficit Hyperactivity Disorder (ADHD) Treatment Market 2032".
4. The Insight Partners, "ADHD Therapeutics Market Size and Share|2030".
5. Texas Health and Human Services, "Dexmethylphenidate Hydrochloride Extended-Release (Focalin XR) Monograph".

Last updated: 2024-12-16