ATOMOXETINE HYDROCHLORIDE - Generic Drug Details

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

Atomoxetine hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Strides Pharma, Teva Pharms Usa, Zydus Pharms Usa Inc, and Lilly, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for atomoxetine hydrochloride. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ATOMOXETINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	185
Patent Applications:	3,062
What excipients (inactive ingredients) are in ATOMOXETINE HYDROCHLORIDE?	ATOMOXETINE HYDROCHLORIDE excipients list
DailyMed Link:	ATOMOXETINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ATOMOXETINE HYDROCHLORIDE

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

Sponsor	Phase
Apnimed	Phase 3
Bronx VA Medical Center	Phase 1
Assiut University	N/A

See all ATOMOXETINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ATOMOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE;ORAL
		80MG	CAPSULE;ORAL
		60MG	CAPSULE;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 ATOMOXETINE HYDROCHLORIDE

Drug Class	Norepinephrine Reuptake Inhibitor
Mechanism of Action	Norepinephrine Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for ATOMOXETINE HYDROCHLORIDE

Adrenergic Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ATOMOXETINE HYDROCHLORIDE

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

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
Dr Reddys	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	090609-001	Feb 23, 2018	AB	RX	No	No
Aurobindo Pharma	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079016-007	May 30, 2017	AB	RX	No	No
Apotex	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	078983-004	May 30, 2017	AB	RX	No	No
Dr Reddys	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	090609-007	Feb 23, 2018	AB	RX	No	No
Aurobindo Pharma	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079016-006	May 30, 2017	AB	RX	No	No
Strides Pharma	ATOMOXETINE HYDROCHLORIDE	atomoxetine hydrochloride	CAPSULE;ORAL	079021-007	Feb 18, 2021	AB	RX	No	No

Expired US Patents for ATOMOXETINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-005	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-001	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-007	Feb 14, 2005
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-006	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-004	Nov 26, 2002
Lilly	STRATTERA	atomoxetine hydrochloride	CAPSULE;ORAL	021411-003	Nov 26, 2002

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.