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Last Updated: December 22, 2024

Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride - Generic Drug Details


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

Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride is the generic ingredient in one branded drug marketed by Commave Therap and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride has eighty-two patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride
International Patents:82
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:dexmethylphenidate hydrochloride; serdexmethylphenidate chloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride
Generic Entry Date for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

US Patents and Regulatory Information for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-003 May 7, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-002 May 7, 2021 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-001 May 7, 2021 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-003 May 7, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Commave Therap AZSTARYS dexmethylphenidate hydrochloride; serdexmethylphenidate chloride CAPSULE;ORAL 212994-002 May 7, 2021 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for dexmethylphenidate hydrochloride; serdexmethylphenidate chloride

Country Patent Number Title Estimated Expiration
Lithuania 2736510 ⤷  Subscribe
Australia 2020239746 ⤷  Subscribe
South Africa 201308766 METHYLPHENIDATE-PRODRUGS,PROCESSES OF MAKING AND USING THE SAME ⤷  Subscribe
Australia 2017371327 ⤷  Subscribe
European Patent Office 4364802 COMPOSITIONS COMPRENANT DES PROMÉDICAMENTS MÉTHYLPHÉNIDATES, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (COMPOSITIONS COMPRISING METHYLPHENIDATE-PRODRUGS, PROCESSES OF MAKING AND USING THE SAME) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Dexmethylphenidate hydrochloride; serdexmethylphenidate chloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexmethylphenidate Hydrochloride and Serdexmethylphenidate Chloride

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 a key player in the broader ADHD therapeutics market, which is experiencing significant growth and dynamics.

ADHD Market Overview

The global ADHD therapeutics market is substantial and growing rapidly. As of 2022, this market was valued at approximately $28.6 billion and is projected to reach $64.7 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 10.8% during this period[1][4].

Market Segmentation by Drug Type

The ADHD market includes various drug types, with stimulants being the most effective and widely prescribed treatments. Dexmethylphenidate hydrochloride falls under this category. However, the segment of the market that includes dexmethylphenidate hydrochloride 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 specific segment, the global ADHD therapeutics market is anticipated to grow significantly. This growth is driven by the increasing prevalence of ADHD, new drug approvals, and improved patient affordability. The market is expected to reach $64.7 billion by 2030[1][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[1].

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[1][4].

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[1].

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[1][5].

Competitive Landscape

The ADHD therapeutics market is highly competitive, with several key sponsors and manufacturers involved in drug development and commercialization. North America, particularly the U.S., dominates the market due to high ADHD prevalence and favorable reimbursement policies[1][4].

Introduction to Serdexmethylphenidate Chloride

Serdexmethylphenidate chloride (SDX) is a novel prodrug of d-methylphenidate (d-MPH), which is currently under evaluation for its abuse potential and therapeutic efficacy. This prodrug is designed to offer a safer and more controlled release of the active ingredient.

Abuse Potential of Serdexmethylphenidate Chloride

Studies have evaluated the abuse potential of SDX chloride when administered orally, intranasally, and intravenously. These studies indicate that SDX chloride has lower abuse-related subjective measures compared to extended-release d-MPH and phentermine. For example, mean Drug Liking VAS scores for SDX chloride were significantly lower than those for d-MPH and phentermine, suggesting a reduced potential for abuse[3].

Market Potential for Serdexmethylphenidate Chloride

Given its novel mechanism and reduced abuse potential, serdexmethylphenidate chloride could potentially capture a significant share of the ADHD therapeutics market. Its entry could offer patients and physicians an alternative with improved safety profiles, which could drive market growth and adoption.

Regional Market Dynamics

North America

North America, particularly the U.S., holds the largest market share in the ADHD therapeutics market. This dominance is driven by high ADHD prevalence and favorable reimbursement policies. The region is expected to continue its leading position throughout the forecast period[1][4].

Europe

The European region holds the second-most significant position in the global market. The growth in this region is driven by emerging technologies, digital medicines, and rising healthcare expenditure[4].

Asia Pacific

The Asia Pacific region is growing at a CAGR of 12.3% during the forecast period. Factors such as unmet needs, a sizeable patient population, and the availability of lower-cost drugs are driving this growth. Improving economies and the expansion of healthcare insurance in countries like Malaysia, Thailand, and Vietnam are also contributing to the regional market's growth[4].

Latin America and Middle East & Africa

The Latin American region is estimated to witness a prominent CAGR during the forecast period. The ADHD therapeutics market in the Middle East and Africa is predicted to grow at a CAGR of 9.31% during the same period[4].

Financial Trajectory

Revenue Projections

The global ADHD therapeutics market is expected to reach $64.7 billion by 2030, growing at a CAGR of 10.8% from 2022 to 2030. For serdexmethylphenidate chloride, while specific revenue projections are not available, its potential to capture a share of this growing market is significant due to its novel characteristics and reduced abuse potential[1][4].

Cost and Pricing Strategies

The pricing of dexmethylphenidate hydrochloride and potentially serdexmethylphenidate chloride will be influenced by factors such as dosage strength, formulation, and competition. The cost of these medications will need to be balanced with their therapeutic benefits and safety profiles to ensure market acceptance and financial viability[1][5].

Key Takeaways

  • Market Growth: Despite a decline in the specific 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.
  • Innovative Treatments: New drugs like serdexmethylphenidate chloride offer potential for reduced abuse and improved safety profiles, which could drive market growth.

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[1].

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[1].

3. Which region dominates the ADHD therapeutics market?

North America, particularly the United States, holds the largest market share[1][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 offer innovative treatment options and are expected to propel market growth by improving treatment outcomes and patient compliance[1].

Key Takeaways

  • The ADHD therapeutics market is poised for significant growth driven by increasing prevalence, new drug approvals, and improved patient affordability.
  • Dexmethylphenidate hydrochloride, despite facing generic competition, remains a key player in the market.
  • Serdexmethylphenidate chloride, with its reduced abuse potential, presents a promising new treatment option that could capture a significant market share.
  • Regional dynamics, particularly in North America and the Asia Pacific, will play a crucial role in shaping the market's future.
"The global ADHD therapeutics market is expected to reach $64.7 billion by 2030, growing at a CAGR of 10.8% from 2022 to 2030"[1].

Sources

  1. DrugPatentWatch - DEXMETHYLPHENIDATE HYDROCHLORIDE - Generic Drug Details
  2. Patsnap - Dexmethylphenidate Hydrochloride - Drug Targets, Indications
  3. Corium Inc. - Oral, intranasal, and intravenous abuse potential of Serdexmethylphenidate (SDX) chloride
  4. MarketDataForecast - ADHD Therapeutics Market Size, Share & Growth Report, 2032
  5. Texas Health and Human Services - Dexmethylphenidate Hydrochloride Extended-Release (Focalin XR) Monograph

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