PAXIL Drug Patent Profile

When do Paxil patents expire, and what generic alternatives are available?

Paxil is a drug marketed by Apotex and is included in four NDAs.

The generic ingredient in PAXIL is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Paxil

A generic version of PAXIL was approved as paroxetine hydrochloride by APOTEX on July 30^th, 2003.

Summary for PAXIL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	3,903
Drug Prices:	Drug price information for PAXIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PAXIL
What excipients (inactive ingredients) are in PAXIL?	PAXIL excipients list
DailyMed Link:	PAXIL at DailyMed

See drug prices for PAXIL

See drug sales revenues for PAXIL

Pharmacology for PAXIL

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

US Patents and Regulatory Information for PAXIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-001	Oct 9, 1998		DISCN	Yes	No
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992	AB	RX	Yes	No
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-004	Oct 9, 1998		DISCN	Yes	No
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999	AB	RX	Yes	No
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-003	Dec 29, 1992	AB	RX	Yes	No

Expired US Patents for PAXIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-005	Dec 29, 1992	4,721,723*PED
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,121,291*PED
Apotex	PAXIL	paroxetine hydrochloride	CAPSULE;ORAL	020885-003	Oct 9, 1998	6,080,759*PED
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992	6,080,759*PED
Apotex	PAXIL	paroxetine hydrochloride	SUSPENSION;ORAL	020710-001	Jun 25, 1997	6,080,759*PED

International Patents for PAXIL

See the table below for patents covering PAXIL around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	536	Oral liquid compositions containing paroxetine resinate
Greece	1003350
Czech Republic	20004923
Slovenia	1089996
Luxembourg	88711

PAXIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paroxetine (PAXIL)

Introduction to Paroxetine (PAXIL)

Paroxetine, commonly known by the brand name PAXIL, is an antidepressant belonging to the selective serotonin reuptake inhibitor (SSRI) class. It is widely used to treat various mental health conditions, including depressive disorder, social anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, obsessive-compulsive disorder, panic disorder, and generalized anxiety disorder[1].

Market Growth and Forecast

The paroxetine market 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[1].
• The broader antidepressant drugs market, which includes paroxetine, is projected to reach approximately USD 30.5 billion by 2033, growing at a CAGR of 7.5% from 2024 to 2033[3].

Drivers of Market Growth

Several factors are driving the growth of the paroxetine market:

• Increasing Prevalence of Mental Health Disorders: The rise in the number of people suffering from mental illnesses globally is a major driver. Conditions such as social anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, depressive disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder are becoming more prevalent[1].
• Technological Advancements and Therapies: The development of new therapies and technologies for treating psychological complications is enhancing market growth. Increased awareness among people regarding mental disorders also contributes to this growth[1].
• Geriatric Population and Healthcare Expenditure: The increase in the geriatric population and rising healthcare expenditure are positive factors influencing the market. Additionally, changes in lifestyle and the surge in the number of pharmaceutical companies are beneficial[1].

Market Segmentation

The paroxetine market is segmented based on several criteria:

• Product Type: Paroxetine Hydrochloride Drug and Paroxetine Mesylate Drug are the primary product types[1].
• Applications: The drug is used for treating depression, panic disorder, social anxiety disorder, and other mental health conditions[1].
• End-Users: Hospitals, homecare, specialty clinics, ambulatory surgical centers, and others are the key end-users[1].
• Distribution Channel: The drug is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[1].

Competitive Landscape

The paroxetine market is highly competitive with several major players:

• Companies like Johnson & Johnson Services Inc., Mallinckrodt plc, Sun Pharmaceutical Industries Ltd., Novartis AG, Endo Pharmaceuticals plc, Zydus Cadila, Mylan N.V., Mayne Pharma Group Limited, Teva Pharmaceutical Industries Ltd, Amneal Pharmaceutical Inc., Avet Pharmaceuticals Inc., Lannett, Aurobindo Pharma, Wockhardt, and Currax Pharmaceuticals LLC are prominent in the market[1].

Financial Performance and Trends

The financial performance of companies involved in the paroxetine market is influenced by various factors:

• Revenue Growth: The overall antidepressant drugs market is expected to grow significantly, with a projected worth of USD 30.5 billion by 2033. This growth is driven by increased demand and advancements in therapeutic treatments[3].
• Operating Profit and Margins: Companies like GSK have seen fluctuations in their operating profits due to factors such as pandemic-related sales, restructuring costs, and investments in R&D. However, tight cost control and favourable legal settlements have helped maintain profitability[5].

Challenges and Restraints

Despite the growth, the paroxetine market faces several challenges:

• Availability of Alternative Drugs: The presence of various classes of drugs can obstruct the market growth of paroxetine. Other antidepressants and therapeutic options may attract patients and healthcare providers, reducing the demand for paroxetine[1].
• Low Awareness: Low awareness among people about mental health disorders and the benefits of paroxetine can challenge the market growth. Educational campaigns and increased awareness programs are necessary to address this issue[1].

Regional Analysis

The paroxetine market is analyzed across various regions:

• North America: Countries like the U.S., Canada, and Mexico are significant markets due to high healthcare expenditure and a large patient base[1].
• Europe: Germany, Italy, U.K., France, and other European countries contribute substantially to the market growth[1].
• Asia Pacific: Countries such as Japan, China, India, and Australia are emerging markets with growing demand for antidepressant drugs[1].

Technological Innovations and R&D

Technological innovations and research and development (R&D) investments are crucial for the paroxetine market:

• Companies are investing heavily in R&D to develop new therapies and improve existing treatments. This includes advancements in drug delivery systems and personalized medicine[3][5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the paroxetine market:

• On one hand, the pandemic has increased the prevalence of mental health disorders, thereby increasing the demand for antidepressants like paroxetine. On the other hand, it has disrupted supply chains and affected the overall healthcare sector, leading to fluctuations in sales and profitability[5].

Consumer Behavior and Awareness

Consumer behavior and awareness play a significant role in the paroxetine market:

• Increased awareness about mental health and the importance of seeking treatment is driving the demand for antidepressants. However, stigma around mental health issues still exists and needs to be addressed through educational campaigns[1].

Key Takeaways

• The paroxetine market is expected to grow at a CAGR of 4.20% from 2022 to 2029.
• The broader antidepressant drugs market is projected to reach USD 30.5 billion by 2033.
• Increasing prevalence of mental health disorders, technological advancements, and rising healthcare expenditure are key drivers.
• The market faces challenges such as the availability of alternative drugs and low awareness among people.
• Regional analysis highlights the significance of North America, Europe, and the Asia Pacific.
• Technological innovations and R&D investments are crucial for market growth.

FAQs

What is the expected growth rate of the paroxetine market from 2022 to 2029?

The paroxetine market is expected to grow at a compound annual growth rate (CAGR) of 4.20% from 2022 to 2029[1].

Which regions are significant for the paroxetine market?

North America, Europe, and the Asia Pacific are significant regions for the paroxetine market due to their large patient bases and high healthcare expenditure[1].

What are the main applications of paroxetine?

Paroxetine is used to treat various mental health conditions including depression, panic disorder, social anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, obsessive-compulsive disorder, and generalized anxiety disorder[1].

How has the COVID-19 pandemic affected the paroxetine market?

The COVID-19 pandemic has increased the demand for antidepressants due to rising mental health issues but has also disrupted supply chains and affected overall healthcare sector profitability[5].

Who are the major players in the paroxetine market?

Major players include Johnson & Johnson Services Inc., Mallinckrodt plc, Sun Pharmaceutical Industries Ltd., Novartis AG, Endo Pharmaceuticals plc, and others[1].

Sources

1. Data Bridge Market Research - Global Paroxetine Market - Industry Trends and Forecast to 2029
2. GSK - Full year and fourth quarter 2020 - GSK
3. PharmiWeb - Antidepressant Drugs Market Shows Promise: Forecast Projects USD 30.5 Billion by 2033
4. Cognitive Market Research - Paroxetine Market Report 2024 (Global Edition)
5. GSK - Full year and fourth quarter 2021 - GSK