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, Alembic, 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, Oxford Pharms, Pharmobedient, Roxane, Sun Pharm Inds Inc, Teva Pharms, Upsher Smith Labs, Yiling, and Zydus Pharms Usa, and is included in thirty 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:	24
NDAs:	30
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	271
Patent Applications:	1,678
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
Medipol University	NA
BioNTech SE	PHASE1
South Valley University	NA

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
Oxford Pharms	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	076968-003	Jun 21, 2010	AB	RX	No	No
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-004	Mar 13, 2008	AB	RX	No	No
Cadila Pharms Ltd	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212645-001	Aug 27, 2021	AB	RX	No	No
Mylan	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078902-001	Mar 13, 2008	AB	RX	No	No
Cadila Pharms Ltd	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212645-003	Aug 27, 2021	AB	RX	No	No
Roxane	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET;ORAL	078026-003	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	5,872,132*PED
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-002	Dec 29, 1992	5,872,132*PED
Apotex	PAXIL	paroxetine hydrochloride	TABLET;ORAL	020031-004	Dec 29, 1992	6,063,927*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	020031-001	Dec 29, 1992	6,113,944*PED

Market Dynamics and Financial Trajectory for Paroxetine Hydrochloride

Last updated: July 27, 2025

Introduction

Paroxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI), has established a significant position within the global antidepressant market. Originally developed by GlaxoSmithKline (GSK) and marketed as Paxil (or Seroxat outside North America), this medication has been widely prescribed for major depressive disorder, obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), and other mental health conditions. Its market performance, driven by patent protections, regulatory landscapes, and emerging therapeutic alternatives, delineates complex market dynamics and a nuanced financial trajectory.

Market Overview

Global Market Size and Growth Trends

The global antidepressant market, including SSRIs like paroxetine, was valued at approximately USD 15 billion in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of 2-4% through 2028 [1]. Growing awareness, rising mental health disorders, and increased adoption of pharmacotherapy sustain this growth trajectory. Paroxetine historically commanded a substantial share due to its efficacy and safety profile for multiple indications. However, recent shifts in prescribing practices and market competition influence its precise market dominance.

Key Market Drivers

• Prevalence of Mental Health Conditions: The World Health Organization reports over 264 million people globally suffer from depression, underscoring steady demand for antidepressants [2].
• Evolving Prescribing Patterns: Clinicians increasingly favor newer antidepressants (e.g., vortioxetine, vilazodone) for their improved side effect profiles, yet SSRIs remain first-line due to established efficacy and familiarity.
• Regulatory Environment: Regulatory approvals or withdrawals significantly impact market dynamics. Paroxetine's patent expiry in many regions has facilitated generic entry, reducing costs and expanding access.
• Generic Competition: The expiration of patent protections has led to a surge in generic paroxetine hydrochloride formulations, intensifying price competition and compressing margins for branded products [3].

Market Constraints and Challenges

• Safety and Tolerability Concerns: Reports of adverse effects such as sexual dysfunction, withdrawal symptoms, and potential for increased suicidal ideation have prompted caution and, in some cases, regulatory warnings that may influence prescribing trends.
• Patent Expiry and Generic Penetration: Since the early 2010s, patent expirations across major markets such as the US, EU, and Japan have resulted in a proliferation of generics, exerting downward pricing pressure.
• Market Saturation and Therapeutic Alternatives: The availability of newer antidepressants with fewer side effects limits paroxetine's market share growth potential.

Regulatory and Patent Landscape

Patent Expiration Timeline

• United States: Paroxetine's patent protections expired around 2005-2010, enabling multiple generic manufacturers to enter the market [4].
• Europe & Japan: Similar expirations occurred between 2008 and 2012, leading to commoditization of the active pharmaceutical ingredient (API).

Regulatory Approvals and Market Access

• Amid increasing competition, regulatory agencies have mandated detailed safety profiles, sometimes restricting indications or usage guidelines.
• Off-label uses remain prevalent but are less supported by regulatory bodies, affecting economic prospects.

Financial Trajectory

Revenue Trends

• Pre-Patent Expiry Period: Branded sales peaked in the early 2000s, with annual revenues reaching USD 1-2 billion globally for paroxetine [5].
• Post-Patent Era: Generic markets have precipitated a decline in branded sales, with current revenues diminished by approximately 80% from peak levels. Global sales are now primarily driven by generic formulations, with estimated annual revenues of USD 100-200 million [6].

Pricing Dynamics

• The entry of generics has reduced wholesale and retail prices significantly. United States prices for generic paroxetine per tablet have fallen by over 70% since patent expiry [7].
• Despite reduced prices, high-volume prescribing in hospital and outpatient settings sustains revenue streams.

Key Players and Market Share

• Generics: Multiple manufacturers, including Teva, Mylan, and Sandoz, dominate the market.
• Branded: GSK's Paxil has largely exited the market, except in specific regions where branding continues due to legacy products or exclusive rights.

Future Revenue Outlook

Given current market trends, revenues for paroxetine hydrochloride are expected to decline further or stabilize at low levels. If pharmaceutical companies develop or promote newer therapies for depression, demand for paroxetine could diminish, impacting long-term financial trajectories.

Emerging Market Dynamics

Regional Variances

• United States: Dominated by generic availability, with limited branded sales.
• Asia-Pacific: Growing mental health awareness and expanding healthcare infrastructure could sustain volumes. Nevertheless, reliance on generics persists.
• Europe: Regulatory restrictions and safety concerns may limit use, although generic penetration remains high.

Impact of Biosimilars and Market Competition

The wider pharmaceutical environment's shift towards biosimilars and generic proliferation foreshadows a highly commoditized market for small-molecule drugs like paroxetine hydrochloride, suppressing potential profit margins.

Strategic Implications for Stakeholders

• Manufacturers: Focus on cost reduction, differentiating formulations, or marketing value-added indications.
• Investors: Caution is advised due to declining revenues, patent expiries, and regulatory risks.
• Regulators: Heightened oversight regarding safety profiles may influence prescribing patterns and access.

Conclusion

The market dynamics for paroxetine hydrochloride are characterized by a typical lifecycle trajectory: robust growth during patent-protected phases, followed by plateau and decline amid patent expirations and intense generic competition. The financial trajectory reflects these shifts, with revenues consolidating at lower levels. Future prospects hinge on whether patent protections can be restored through formulations or new indications, or if the market pivots toward competing therapies.

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Key Takeaways

• Paroxetine hydrochloride historically represented a significant share of the antidepressant market, driven by efficacy and safety profile.
• Patent expirations from the late 2000s triggered widespread generic entry, leading to drastic reductions in brand revenues.
• The current market landscape is driven by high-volume, low-margin generic sales amid mounting competition from newer antidepressants with improved safety profiles.
• Regulatory scrutiny and safety concerns influence prescribing trends, further reducing paroxetine’s market potential.
• Long-term prospects are limited unless innovation or new therapeutic applications emerge, or patent protections can be fortified.

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FAQs

1. How has patent expiration impacted the profitability of paroxetine hydrochloride?
Patent expirations in the late 2000s facilitated generic entry, leading to significant price reductions and a sharp decrease in branded sales, severely impacting profitability for original patent holders.

2. Are there any new formulations or indications that could revitalize paroxetine's market?
Currently, no significant novel formulations or indications are in advanced development stages. Most efforts focus on newer antidepressants, although research into off-label uses remains limited.

3. How does the safety profile of paroxetine influence its market trajectory?
Concerns regarding sexual dysfunction, withdrawal phenomena, and increased risk of suicidal ideation have led to regulatory warnings and caution in prescribing, constraining market expansion.

4. What regional factors affect paroxetine hydrochloride's market dynamics?
Regional regulations, healthcare infrastructure, and mental health prevalence influence demand. Developed markets with established generics see declining sales, while emerging markets may still utilize paroxetine, albeit with increasing competition from other therapies.

5. What strategic actions should pharmaceutical companies consider regarding paroxetine hydrochloride?
Focus on cost leadership, exploring novel formulations, or securing orphan or secondary indications to extend lifecycle. Diversifying into newer therapeutic classes might also be more profitable, given the declining outlook for established SSRIs.

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Sources

[1] Allied Market Research, "Antidepressant Market Outlook," 2022.
[2] WHO, "Depression Fact Sheet," 2023.
[3] U.S. Food & Drug Administration, "ANDA Approvals and Patent Status," 2021.
[4] IMS Health, "Patent Expiry and Generic Entry Timeline," 2012.
[5] GSK Annual Reports, "Paroxetine Sales Data," 2010.
[6] MarketWatch, "Generic Paroxetine Market Analysis," 2022.
[7] IQVIA, "Drug Price Trends," 2022.