PAXIL CR Drug Patent Profile

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

Paxil Cr is a drug marketed by Apotex and is included in one NDA.

The generic ingredient in PAXIL CR 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 Cr

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

Summary for PAXIL CR

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

See drug prices for PAXIL CR

See drug sales revenues for PAXIL CR

Pharmacology for PAXIL CR

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for PAXIL CR

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 PAXIL CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999	AB	RX	Yes	No
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999	AB	RX	Yes	No
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-003	Dec 6, 2000	AB	RX	Yes	Yes

Expired US Patents for PAXIL CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-001	Feb 16, 1999
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-002	Feb 16, 1999
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-003	Dec 6, 2000
Apotex	PAXIL CR	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020936-003	Dec 6, 2000

International Patents for PAXIL CR

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

Country	Patent Number	Title	Estimated Expiration
France	2780728
Australia	2002100370
Finland	20030370
Spain	2158778
Poland	189247

PAXIL CR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PAXIL CR

Introduction

PAXIL CR, the controlled-release formulation of paroxetine, is a significant player in the antidepressant market, particularly for treating major depressive disorder, panic disorder, and social anxiety disorder. Here, we will delve into the market dynamics and financial trajectory of PAXIL CR.

Market Segmentation and Target Audience

The market for PAXIL CR is segmented based on several factors, including drug class, disease type, distribution channel, and region.

Drug Class

PAXIL CR falls under the category of Selective Serotonin Reuptake Inhibitors (SSRIs), which are widely used for treating various mental health conditions[4].

Disease Type

PAXIL CR is indicated for the treatment of major depressive disorder, panic disorder with or without agoraphobia, and social anxiety disorder. These indications position it as a versatile treatment option in the mental health sector[1].

Distribution Channel

The drug is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. This diverse distribution network ensures widespread availability and accessibility[4].

Region

The global market for PAXIL CR is significant, with North America being a major contributor due to the high prevalence of depression and anxiety disorders in this region. Other lucrative markets include Europe, Asia-Pacific, and South America[3].

Clinical Efficacy and Market Impact

Clinical Trials and Efficacy

PAXIL CR has demonstrated significant efficacy in clinical trials. For instance, in studies involving patients with major depressive disorder, PAXIL CR showed superior results compared to placebo, as measured by the Hamilton Depression Rating Scale (HDRS) and the Clinical Global Impression (CGI)–Severity of Illness score[1].

Market Response

The effectiveness of PAXIL CR in treating various mental health conditions has contributed to its strong market presence. The drug's controlled-release formulation, which delays the start of drug release until the tablet leaves the stomach, enhances patient compliance and reduces side effects[1].

Financial Performance and Revenue

Historical Revenue

PAXIL CR, developed by GlaxoSmithKline (GSK), has been a part of the company's robust pharmaceutical portfolio. In the early 2000s, GSK reported strong financial performance, with pharmaceutical sales growing significantly. Although specific revenue figures for PAXIL CR are not isolated, the overall success of GSK's CNS products, including PAXIL CR, contributed to the company's financial strength[5].

Current Market Trends

The global depression drugs market, which includes PAXIL CR, is projected to grow at a CAGR of 2.3% from 2020 to 2030, reaching a valuation of approximately $24.3 billion by the end of 2030. This growth is driven by increasing awareness and diagnosis of depression, as well as the development of new pharmacologic and non-pharmacologic interventions[3].

Impact of COVID-19

The COVID-19 pandemic has had a notable impact on the demand for antidepressants, including PAXIL CR. The lockdowns and associated mental health challenges have led to an increase in prescriptions for antidepressants and antianxiety medications, contributing to the market's growth during the pandemic period[3].

Competitive Landscape

Key Players

The market for antidepressants is highly competitive, with key players including Johnson & Johnson, Otsuka Pharmaceutical Co., Ltd., Allergan, Novartis AG, Eli Lilly and Company, Takeda Pharmaceutical Company Limited, Abbott, Pfizer, and GlaxoSmithKline. PAXIL CR competes with other SSRIs and SNRIs in this crowded market[3].

Regulatory Dynamics

The paroxetine market, including PAXIL CR, is subject to varying regulatory landscapes across different regions. Changes in regulatory policies and the approval of new drugs can significantly impact the market dynamics and the financial trajectory of PAXIL CR[4].

Distribution and Pricing Strategies

Distribution Channels

PAXIL CR is available through a variety of distribution channels, ensuring broad accessibility. This includes hospital pharmacies, retail pharmacies, and online pharmacies, which helps in maintaining a strong market presence[4].

Pricing

The pricing strategy for PAXIL CR is influenced by factors such as competition, regulatory approvals, and the overall economic conditions. Given the generic availability of paroxetine, the pricing of PAXIL CR must be competitive to maintain market share[4].

Future Outlook

Market Growth

The global depression drugs market, including PAXIL CR, is expected to continue growing, albeit at a modest CAGR. Ongoing research and development, increasing collaborations between research institutes and pharmaceutical companies, and the growing prevalence of depression are key drivers of this growth[3].

Innovations and Developments

The approval of new treatments, such as unique postpartum depression drugs and nasal sprays for treatment-resistant depression, indicates a trend towards innovative solutions in the mental health sector. PAXIL CR, with its established efficacy and controlled-release formulation, remains a viable option but must adapt to these evolving market trends[3].

Key Takeaways

• Clinical Efficacy: PAXIL CR has demonstrated significant efficacy in treating major depressive disorder, panic disorder, and social anxiety disorder.
• Market Segmentation: The drug is segmented based on drug class, disease type, distribution channel, and region.
• Financial Performance: Part of GSK's strong pharmaceutical portfolio, with the global depression drugs market expected to grow at a CAGR of 2.3%.
• Competitive Landscape: Competes with other SSRIs and SNRIs in a highly competitive market.
• Distribution and Pricing: Available through various distribution channels, with pricing influenced by competition and regulatory factors.
• Future Outlook: Expected to grow modestly, driven by ongoing R&D and increasing prevalence of depression.

FAQs

Q: What are the primary indications for PAXIL CR?

A: PAXIL CR is indicated for the treatment of major depressive disorder, panic disorder with or without agoraphobia, and social anxiety disorder[1].

Q: How does the controlled-release formulation of PAXIL CR work?

A: The controlled-release formulation of PAXIL CR uses a GEOMATRIX™ system to control the dissolution rate of paroxetine over 4 to 5 hours and includes an enteric coat to delay drug release until the tablet leaves the stomach[1].

Q: What is the expected growth rate of the global depression drugs market?

A: The global depression drugs market is expected to grow at a CAGR of 2.3% from 2020 to 2030[3].

Q: How has the COVID-19 pandemic impacted the demand for PAXIL CR?

A: The COVID-19 pandemic has led to an increase in prescriptions for antidepressants and antianxiety medications, contributing to the market's growth during the pandemic period[3].

Q: Who are the key players in the market for antidepressants like PAXIL CR?

A: Key players include Johnson & Johnson, Otsuka Pharmaceutical Co., Ltd., Allergan, Novartis AG, Eli Lilly and Company, Takeda Pharmaceutical Company Limited, Abbott, Pfizer, and GlaxoSmithKline[3].

Sources

1. PAXIL CR Label - FDA.
2. Pfizer Reports Fourth-Quarter and Full-Year 2019 Results - Pfizer.
3. Depression Drugs Market - Transparency Market Research.
4. Paroxetine Market - Market Research Future.
5. GlaxoSmithKline Annual Review 2002 - GlaxoSmithKline.