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Last Updated: December 22, 2024

ATOMOXETINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Atomoxetine Hydrochloride, and what generic alternatives are available?

Atomoxetine Hydrochloride is a drug marketed by Apotex, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Strides Pharma, Teva Pharms Usa, and Zydus Pharms Usa Inc. and is included in eight NDAs.

The generic ingredient in ATOMOXETINE HYDROCHLORIDE is atomoxetine hydrochloride. There are sixteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Atomoxetine Hydrochloride

A generic version of ATOMOXETINE HYDROCHLORIDE was approved as atomoxetine hydrochloride by ZYDUS PHARMS USA INC on September 16th, 2010.

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Drug patent expirations by year for ATOMOXETINE HYDROCHLORIDE
Recent Clinical Trials for ATOMOXETINE HYDROCHLORIDE

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

SponsorPhase
ApnimedPhase 3
Bronx VA Medical CenterPhase 1
Assiut UniversityN/A

See all ATOMOXETINE HYDROCHLORIDE clinical trials

Pharmacology for ATOMOXETINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for ATOMOXETINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ATOMOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STRATTERA Capsules atomoxetine hydrochloride 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg 021411 10 2007-05-29

US Patents and Regulatory Information for ATOMOXETINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079021-006 Feb 18, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 202682-004 Mar 11, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079022-007 May 30, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079022-003 May 30, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms Usa Inc ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017-007 Apr 5, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms Usa Inc ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017-005 Sep 16, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ATOMOXETINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atomoxetine Hydrochloride

Introduction

Atomoxetine hydrochloride, a non-stimulant medication, is primarily used to treat Attention Deficit/Hyperactivity Disorder (ADHD). The market for this drug is experiencing significant growth, driven by several key factors. Here, we will delve into the market dynamics, financial trajectory, and the various elements influencing the atomoxetine hydrochloride market.

Market Size and Growth Projections

The global atomoxetine hydrochloride market is anticipated to witness substantial growth over the forecast period from 2023 to 2031. According to market research, the market size is expected to expand at a compound annual growth rate (CAGR) of around 5% during this period[4].

Global Market Size

In 2024, the global atomoxetine HCl API market size was estimated to be in the millions of USD, with projections indicating it will reach significantly higher values by 2031[4].

Regional Market Dynamics

  • North America: This region dominated the market in 2024, accounting for around 40% of the global revenue. The growth here is driven by increasing ADHD diagnoses, rising awareness, and demand for effective treatments, along with robust healthcare infrastructure and supportive regulatory frameworks[4].
  • Europe: Europe is the fastest-growing region, driven by heightened awareness of ADHD, growing diagnosis rates, and the demand for effective treatments. The region benefits from well-installed healthcare infrastructure and stringent regulatory standards[4].
  • Asia-Pacific: This region holds a significant share of the global market, with a CAGR of 7.0% from 2024 to 2031. The growing awareness and increasing diagnosis rates of ADHD in this region are key drivers[4].
  • Latin America and Middle East & Africa: These regions also show promising growth, with CAGRs of 4.4% and 4.7%, respectively, from 2024 to 2031[4].

Market Drivers

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

Increasing ADHD Diagnoses

The rising number of ADHD diagnoses globally is a significant driver. As more cases are identified, the demand for effective treatments like atomoxetine hydrochloride increases[4].

Growing Awareness and Demand for Effective Treatments

Heightened awareness about ADHD and the need for effective treatments are pushing the market forward. Patients and healthcare providers are increasingly seeking non-stimulant alternatives like atomoxetine hydrochloride[4].

Improvements in Healthcare Infrastructure

Regions with well-developed healthcare infrastructure, such as North America and Europe, are seeing rapid growth in the atomoxetine hydrochloride market. This infrastructure supports better diagnosis and treatment options[4].

Regulatory Frameworks

Supportive regulatory frameworks in various regions are facilitating the production and distribution of atomoxetine hydrochloride, contributing to market growth[4].

Market Restraints

Despite the growth, there are several restraints to consider:

Cost-Effectiveness

Economic evaluations have shown that while atomoxetine is effective, its cost-effectiveness can vary. For instance, the incremental cost per quality-adjusted life-year (QALY) for atomoxetine compared to other treatments like methylphenidate can be significant[2][3].

Side Effects and Safety Concerns

Atomoxetine hydrochloride is associated with several side effects, including abdominal pain, decreased appetite, nausea, and serious side effects like liver problems and heart issues. These safety concerns can impact market growth[5].

Competition from Other Treatments

The ADHD treatment market is competitive, with other medications like methylphenidate and dexamfetamine available. The choice of treatment often depends on factors like cost, efficacy, and patient tolerance[3].

Economic Evaluation

Economic models have been developed to assess the cost-effectiveness of atomoxetine hydrochloride compared to other ADHD treatments.

Cost-Effectiveness Analysis

A study using a Markov model found that atomoxetine offers value-for-money in the treatment of ADHD, especially for patients who are ineligible for stimulant medications due to contraindications or previous treatment failures[2].

Comparative Analysis

Another study comparing atomoxetine with methylphenidate and dexamfetamine found that while there are no significant differences in efficacy, the economic model is driven by drug costs. Atomoxetine is preferred for patients contraindicated to stimulants[3].

Pharmacokinetics and Therapeutic Effects

Understanding the pharmacokinetics and therapeutic effects of atomoxetine hydrochloride is crucial for its market positioning.

Mechanism of Action

Atomoxetine alleviates ADHD symptoms through norepinephrine reuptake inhibition and indirectly increasing dopamine in the prefrontal cortex. This mechanism is distinct from stimulant medications and offers a non-stimulant alternative[5].

Pharmacokinetic Profile

Atomoxetine is rapidly and completely absorbed orally, with a bioavailability that varies based on CYP2D6 metabolism. The half-life of atomoxetine and its metabolites can vary significantly between individuals, affecting dosing strategies[5].

Market Segmentation

The atomoxetine hydrochloride market is segmented based on several criteria:

Type

The market is segmented by purity levels (Purity ≥ 99% and Purity < 99%)[1].

Application

Atomoxetine hydrochloride is used in various formulations, including capsules and oral solutions[1].

Geographical Regions

The market is analyzed across different geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1][4].

Key Players and Competitive Landscape

The competitive landscape of the atomoxetine hydrochloride market includes several key players involved in the production and distribution of the drug. These companies are focused on research and development, regulatory compliance, and market expansion strategies.

Future Outlook

The future outlook for the atomoxetine hydrochloride market is promising, driven by the increasing prevalence of ADHD and the growing demand for non-stimulant treatments.

Research and Development

Ongoing research and development activities are expected to improve the efficacy and safety profile of atomoxetine hydrochloride, further boosting its market position[4].

Regulatory Support

Continued support from regulatory frameworks will be crucial for the market's growth, ensuring that the drug meets stringent safety and efficacy standards[4].

Key Takeaways

  • The global atomoxetine hydrochloride market is expected to grow at a CAGR of around 5% from 2024 to 2031.
  • North America and Europe are key regions driving market growth due to increasing ADHD diagnoses and robust healthcare infrastructure.
  • The market is segmented by type, application, and geographical regions.
  • Economic evaluations highlight the cost-effectiveness of atomoxetine hydrochloride, especially for patients ineligible for stimulant medications.
  • The drug's unique mechanism of action and pharmacokinetic profile position it as a valuable non-stimulant alternative in ADHD treatment.

FAQs

What is the primary use of atomoxetine hydrochloride?

Atomoxetine hydrochloride is primarily used to treat Attention Deficit/Hyperactivity Disorder (ADHD)[5].

What are the common side effects of atomoxetine hydrochloride?

Common side effects include abdominal pain, decreased appetite, nausea, feeling tired, and dizziness. Serious side effects may include liver problems, heart issues, and psychosis[5].

How does atomoxetine hydrochloride compare to other ADHD treatments in terms of cost-effectiveness?

Economic evaluations show that atomoxetine hydrochloride offers value-for-money, especially for patients who are ineligible for stimulant medications. However, its cost-effectiveness can vary compared to other treatments like methylphenidate[2][3].

What regions are driving the growth of the atomoxetine hydrochloride market?

North America and Europe are the key regions driving market growth, followed by significant contributions from the Asia-Pacific region[4].

What are the market restraints for atomoxetine hydrochloride?

Market restraints include the cost-effectiveness compared to other treatments, side effects and safety concerns, and competition from other ADHD medications[2][3][5].

Sources

  1. Market Research Intellect: Global Atomoxetine Hydrochloride Market Size, Trends and Forecasts Report.
  2. PubMed: A modelled economic evaluation comparing atomoxetine with methylphenidate in the treatment of ADHD.
  3. PubMed: A systematic review and economic model of the effectiveness and cost-effectiveness of oral methylphenidate hydrochloride, dexamfetamine sulphate, and atomoxetine in children and adolescents with ADHD.
  4. Cognitive Market Research: Global Atomoxetine HCl API Market Report 2024.
  5. Wikipedia: Atomoxetine.

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