PAROXETINE HYDROCHLORIDE - Generic Drug Details

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

Paroxetine hydrochloride is the generic ingredient in four branded drugs marketed by Apotex, Apotex Inc, Novitium Pharma, Aurobindo Pharma Usa, Cadila Pharms Ltd, Cspc Ouyi, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Prinston Inc, Sciecure Pharma Inc, Aurobindo Pharma, Chartwell Rx, Jubilant Generics, Mylan, Norvium Bioscience, Oxford Pharms, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for paroxetine hydrochloride. Forty-four suppliers are listed for this compound.

Summary for PAROXETINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	23
NDAs:	29
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	259
Patent Applications:	1,649
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PAROXETINE HYDROCHLORIDE
What excipients (inactive ingredients) are in PAROXETINE HYDROCHLORIDE?	PAROXETINE HYDROCHLORIDE excipients list
DailyMed Link:	PAROXETINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PAROXETINE HYDROCHLORIDE

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Cairo University	Phase 3
The Medical Research Network	Phase 4

See all PAROXETINE HYDROCHLORIDE clinical trials

Pharmacology for PAROXETINE HYDROCHLORIDE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PAROXETINE HYDROCHLORIDE

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PAROXETINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PAXIL CR	Extended-release Tablets	paroxetine hydrochloride	37.5 mg	020936	1	2009-05-19
PAXIL CR	Extended-release Tablets	paroxetine hydrochloride	25 mg	020936	1	2005-09-09

US Patents and Regulatory Information for PAROXETINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cspc Ouyi	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	213485-002	Feb 16, 2021	AB	RX	No	No
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992	AB	RX	Yes	No
Sun Pharm Inds Inc	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078194-002	Jun 29, 2007		DISCN	No	No
Oxford Pharms	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	076968-004	Jun 21, 2010	AB	RX	No	No
Roxane	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078026-004	Jun 29, 2007		DISCN	No	No

Expired US Patents for PAROXETINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-003	Dec 6, 2000
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998

PAROXETINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paroxetine Hydrochloride

Introduction

Paroxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI), is widely used for treating various mental health disorders, including depression, anxiety, and obsessive-compulsive disorder. The market for paroxetine hydrochloride is influenced by several factors, including increasing prevalence of mental health issues, advancements in healthcare, and changing consumer behaviors.

Market Growth and Forecast

The paroxetine market is anticipated to experience steady growth over the forecast period. Here are some key projections:

• The global paroxetine market is expected to grow at a compound annual growth rate (CAGR) of 4.20% from 2022 to 2029[1].
• Another forecast suggests a CAGR of 3 to 5% for the paroxetine hydrochloride market from 2021 to 2031[4].

This growth is driven by the increasing number of people suffering from mental illnesses globally, as well as advancements in therapeutic technologies and rising awareness about mental health.

Market Segmentation

The paroxetine hydrochloride market is segmented based on several criteria:

Product Type

• The market is segmented into paroxetine hydrochloride and paroxetine mesylate drugs. Paroxetine hydrochloride is the more commonly used form[1].

Applications

• The drug is used to treat a variety of conditions, including depression, panic disorder, social anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, obsessive-compulsive disorder, and generalized anxiety disorder[1].

End-Users

• The market is segmented into hospitals, homecare, specialty clinics, ambulatory surgical centers, and other healthcare settings[1].

Distribution Channel

• The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. The rise of online pharmacies is expected to contribute significantly to market growth[1].

Regional Analysis

The global paroxetine hydrochloride market is analyzed across various regions:

• North America: This region dominates the market due to its well-developed healthcare system and high awareness of mental health issues[1].
• Asia-Pacific: Expected to witness high growth due to the large population and increasing healthcare expenditure in countries like China, India, and Japan[1].
• Europe: Significant market share due to the presence of advanced healthcare infrastructure and high prevalence of mental health disorders[1].
• South America and Middle East & Africa: These regions are also expected to contribute to the market growth, though at a slower pace compared to North America and Asia-Pacific[1].

Drivers of Market Growth

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

• Increasing Prevalence of Mental Health Disorders: The rise in the number of people suffering from mental illnesses such as depression, anxiety, and obsessive-compulsive disorder is a major driver[1].
• Advancements in Therapeutic Technologies: New therapies and treatment options are enhancing the effectiveness of paroxetine hydrochloride, attracting more patients and healthcare providers[1].
• Rising Awareness and Healthcare Expenditure: Increased awareness about mental health and higher healthcare spending are contributing to the market's growth[1].
• Geriatric Population: The growing geriatric population, which is more prone to mental health issues, is another significant factor[1].

Challenges and Restraints

Despite the positive growth trajectory, the market faces some challenges:

• Availability of Alternative Drugs: The presence of various classes of antidepressant drugs can obstruct the growth of the paroxetine hydrochloride market[1].
• Low Awareness in Some Regions: Limited awareness about mental health and available treatments in certain regions can hinder market growth[1].

Financial Trajectory

The financial outlook for the paroxetine hydrochloride market is promising:

• Market Size: The global paroxetine hydrochloride market size is estimated to grow significantly from its current valuation. For instance, the market size is expected to increase from its estimated valuation in 2023 to a projected value by 2031[3][4].
• Revenue Growth: The revenue growth is anticipated to be steady, with a CAGR ranging from 3 to 5% over the forecast period[4].

Competitive Landscape

The market is competitive with several key players:

• Market Share: The market share is distributed among various pharmaceutical companies, with some players dominating specific regions or segments[3].
• Product Launches and Innovations: Companies are focusing on product launches, geographic expansions, and technological innovations to maintain their market position[1].

Technological and Therapeutic Advancements

Advancements in therapeutic technologies are crucial for the market:

• Enhanced Therapies: New and improved therapies for treating psychological complications are extending profitable opportunities for market players[1].
• Pharmacokinetics and Metabolism: Understanding the pharmacokinetics and metabolism of paroxetine hydrochloride, such as its extensive metabolism and excretion, helps in developing more effective treatment plans[5].

Regulatory Environment

Regulatory factors also play a significant role:

• Trade Regulations and Import/Export Analysis: Market growth is influenced by trade regulations, import/export policies, and other regulatory factors[1].
• Product Approvals: Regulatory approvals for new formulations and dosages of paroxetine hydrochloride are essential for market expansion[1].

Consumer Behavior and Awareness

Consumer behavior and awareness are critical drivers:

• Increasing Awareness: Rising awareness about mental health issues and the availability of treatments like paroxetine hydrochloride is driving market growth[1].
• Changing Lifestyle: Changes in lifestyle, including increased stress and other factors, are contributing to the higher demand for mental health treatments[1].

Key Takeaways

• The paroxetine hydrochloride market is expected to grow at a CAGR of 4.20% from 2022 to 2029.
• The market is driven by the increasing prevalence of mental health disorders, advancements in therapeutic technologies, and rising awareness.
• North America dominates the market, while Asia-Pacific is expected to witness high growth.
• Challenges include the availability of alternative drugs and low awareness in some regions.
• The financial trajectory is promising, with steady revenue growth anticipated.

FAQs

What are the primary applications of paroxetine hydrochloride?

Paroxetine hydrochloride is primarily used to treat depression, panic disorder, social anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, obsessive-compulsive disorder, and generalized anxiety disorder[1].

Which regions are expected to drive the growth of the paroxetine hydrochloride market?

North America currently dominates the market, while Asia-Pacific is expected to witness high growth due to its large population and increasing healthcare expenditure[1].

What are the key drivers of the paroxetine hydrochloride market?

The key drivers include the increasing prevalence of mental health disorders, advancements in therapeutic technologies, rising awareness about mental health, and higher healthcare expenditure[1].

What challenges does the paroxetine hydrochloride market face?

The market faces challenges such as the availability of various classes of antidepressant drugs and low awareness about mental health in some regions[1].

How is the competitive landscape of the paroxetine hydrochloride market?

The market is competitive, with several key players focusing on product launches, geographic expansions, and technological innovations to maintain their market position[1].

Sources

1. Data Bridge Market Research: Global Paroxetine Market - Industry Trends and Forecast to 2029.
2. PMC: Trajectories of Depression Severity in Clinical Trials of Duloxetine.
3. Cognitive Market Research: Paroxetine Hydrochloride Tablet Market Report 2024 (Global Edition).
4. Market Research Intellect: Global Paroxetine Hydrochloride Market Size and Forecast.
5. FDA: PAXIL (PAROXETINE HYDROCHLORIDE) label.