Paroxetine mesylate - Generic Drug Details

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

Paroxetine mesylate is the generic ingredient in three branded drugs marketed by Sebela Ireland Ltd, Actavis Labs Fl Inc, and Prinston Inc, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paroxetine mesylate has eighty-four patent family members in thirty-six countries.

There are two drug master file entries for paroxetine mesylate. Two suppliers are listed for this compound.

Summary for paroxetine mesylate

International Patents:	84
US Patents:	4
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	5
Patent Applications:	310
Drug Prices:	Drug price trends for paroxetine mesylate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paroxetine mesylate
What excipients (inactive ingredients) are in paroxetine mesylate?	paroxetine mesylate excipients list
DailyMed Link:	paroxetine mesylate at DailyMed

See drug prices for paroxetine mesylate

Recent Clinical Trials for paroxetine mesylate

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

Sponsor	Phase
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Noven Therapeutics	Phase 1

See all paroxetine mesylate clinical trials

Pharmacology for paroxetine mesylate

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for paroxetine mesylate

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

Paragraph IV (Patent) Challenges for PAROXETINE MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRISDELLE	Capsules	paroxetine mesylate	7.5 mg	204516	1	2014-04-07

US Patents and Regulatory Information for paroxetine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	7,598,271			Y
Actavis Labs Fl Inc	PAROXETINE MESYLATE	paroxetine mesylate	CAPSULE;ORAL	207139-001	Jun 20, 2017	AB	RX	No	No
Sebela Ireland Ltd	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516-001	Jun 28, 2013	AB	RX	Yes	Yes	8,946,251		Y	Y

Expired US Patents for paroxetine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003	6,703,408
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-001	Jul 3, 2003	5,874,447
Sebela Ireland Ltd	PEXEVA	paroxetine mesylate	TABLET;ORAL	021299-003	Jul 3, 2003	5,874,447

International Patents for paroxetine mesylate

Country	Patent Number	Title	Estimated Expiration
Estonia	200200633
Serbia	57980
Israel	196844

Paroxetine mesylate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paroxetine Mesylate

Introduction to Paroxetine Mesylate

Paroxetine mesylate, a selective serotonin reuptake inhibitor (SSRI), is widely used for treating various psychiatric disorders, including major depressive disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, and generalized anxiety disorder. It is also effective in managing symptoms of menopause such as hot flashes and night sweats[5].

Market Growth and Forecast

The paroxetine market, including paroxetine mesylate, is anticipated to experience significant growth over the coming years. Here are some key forecasts:

• The global paroxetine market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.20% from 2022 to 2029, driven by the increasing prevalence of mental health disorders and advancements in therapeutic technologies[1].
• Another forecast suggests a CAGR of 3 to 5% from 2023 to 2031, indicating a robust expansion in the market dynamics during this period[3].

Market Drivers

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

• Increasing Prevalence of Mental Health Disorders: The rise in the number of people suffering from mental illnesses such as depression, panic disorder, social anxiety disorder, and posttraumatic stress disorder is a major driver. This increase is attributed to changing lifestyles, stress, and greater awareness about mental health issues[1][3].
• Advancements in Therapeutic Technologies: The development of new therapies and treatment options for psychological complications is enhancing the market. This includes improved formulations like controlled release versions designed to reduce side effects such as nausea[5].
• Rise in Healthcare Expenditure: Increased spending on healthcare globally is contributing to the growth of the paroxetine market. This includes higher investments in pharmaceutical research and development[1].
• Growing Geriatric Population: The elderly population is more prone to mental health issues, and the increase in this demographic is positively impacting the market[1].

Market Segmentation

The paroxetine mesylate market is segmented in several ways:

• By Product Type: The market is segmented into paroxetine hydrochloride and paroxetine mesylate drugs. Paroxetine mesylate is particularly noted for its potent inhibition of serotonin reuptake and its use in various psychiatric disorders[1][3].
• By Application: The primary applications include depression, panic disorder, social anxiety disorder, and other psychiatric conditions. Paroxetine mesylate is effective in treating a broad range of these disorders[1][3][4].
• By End-Users: The market is segmented into hospitals, homecare, specialty clinics, ambulatory surgical centers, and others. This diverse range of end-users indicates the widespread use of paroxetine mesylate across different healthcare settings[1].
• By Distribution Channel: The distribution channels include hospital pharmacy, retail pharmacy, and online pharmacy. The rise of online pharmacies is expected to further boost the market[1].

Competitive Landscape

The paroxetine mesylate market is highly competitive with several major players:

• Key Players: Companies such as Johnson & Johnson Services Inc., Mallinckrodt plc, Sun Pharmaceutical Industries Ltd., Novartis AG, Teva Pharmaceutical Industries Ltd, and others are prominent in the market. These companies are investing heavily in research and development to enhance their product offerings and market share[1][4].
• Market Share and Initiatives: The competitive landscape includes details on company financials, revenue generated, market potential, and new market initiatives. These factors are crucial in understanding the competitive dynamics and the strategies employed by market leaders[1].

Financial Trajectory

The financial outlook for the paroxetine mesylate market is promising:

• Revenue Growth: The market is expected to grow significantly, with forecasts indicating a substantial increase in revenue from 2023 to 2031. The estimated valuation of the market is expected to rise, driven by the increasing demand for paroxetine mesylate and other SSRIs[3].
• Investment and Research: Pharmaceutical companies are investing heavily in research and development to improve existing formulations and develop new ones. This investment is expected to yield higher returns as the market expands[1].

Challenges and Restraints

Despite the positive growth trajectory, there are some challenges facing the paroxetine mesylate market:

• Availability of Alternative Drugs: The presence of various classes of drugs can obstruct the growth of the paroxetine mesylate market. Patients and healthcare providers may opt for other treatment options, which could impact the demand for paroxetine mesylate[1].
• Low Awareness: In some regions, there is low awareness about mental health disorders and the available treatments. This lack of awareness can challenge the market growth, especially in areas where mental health issues are stigmatized[1].

Clinical Efficacy and Safety

Paroxetine mesylate has been proven to be clinically effective in treating various psychiatric disorders:

• Clinical Trials: Studies have shown that paroxetine mesylate is effective in reducing symptoms of depression, panic disorder, and generalized anxiety disorder. For example, in trials for panic disorder, patients receiving paroxetine demonstrated a lower relapse rate compared to those on placebo[2].
• Safety Profile: While paroxetine mesylate is generally well-tolerated, it does come with some risks, such as an increased risk of suicidal thinking and behavior in children, adolescents, and young adults. However, in adults aged 65 and older, there was a reduction in the risk of suicidality compared to placebo[2].

Regional Analysis

The paroxetine mesylate market is analyzed across various regions:

• Global Reach: The market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique opportunities and challenges based on local healthcare systems, regulatory environments, and patient demographics[1][3].

Key Takeaways

• The paroxetine mesylate market is expected to grow significantly due to the increasing prevalence of mental health disorders and advancements in therapeutic technologies.
• The market is segmented by product type, application, end-users, and distribution channels, each contributing to its growth.
• Major players are investing heavily in research and development to maintain their market share.
• Despite challenges such as the availability of alternative drugs and low awareness in some regions, the market is poised for robust growth.

FAQs

Q: What are the primary applications of paroxetine mesylate? A: Paroxetine mesylate is primarily used for treating depression, panic disorder, social anxiety disorder, posttraumatic stress disorder, and generalized anxiety disorder[1][3][4].

Q: Which companies are major players in the paroxetine mesylate market? A: Key players include Johnson & Johnson Services Inc., Mallinckrodt plc, Sun Pharmaceutical Industries Ltd., Novartis AG, Teva Pharmaceutical Industries Ltd, and others[1][4].

Q: What is the expected growth rate of the paroxetine mesylate market? A: The market is expected to grow at a CAGR of 4.20% from 2022 to 2029 and 3 to 5% from 2023 to 2031[1][3].

Q: What are the main challenges facing the paroxetine mesylate market? A: The main challenges include the availability of alternative drugs and low awareness about mental health disorders in some regions[1].

Q: How is paroxetine mesylate clinically effective? A: Paroxetine mesylate has been shown to be effective in reducing symptoms of various psychiatric disorders through clinical trials, although it comes with some risks such as increased suicidality in young patients[2].

Sources

1. Data Bridge Market Research: Global Paroxetine Market - Industry Trends and Forecast to 2029.
2. FDA: PEXEVA® Brand of (paroxetine mesylate) tablets Suicidality and Antidepressant Drugs.
3. Market Research Intellect: Global paroxetine market size and forecast.
4. Valuates Reports: Paroxetine Mesylate Market, Report Size, Worth, Revenue, Growth.
5. DrugBank Online: Paroxetine mesylate.