ZOLOFT Drug Patent Profile

Which patents cover Zoloft, and what generic alternatives are available?

Zoloft is a drug marketed by Viatris and is included in two NDAs.

The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zoloft

A generic version of ZOLOFT was approved as sertraline hydrochloride by STRIDES PHARMA on June 30^th, 2006.

Summary for ZOLOFT

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	143
Patent Applications:	5,263
Drug Prices:	Drug price information for ZOLOFT
Drug Sales Revenues:	Drug sales revenues for ZOLOFT
What excipients (inactive ingredients) are in ZOLOFT?	ZOLOFT excipients list
DailyMed Link:	ZOLOFT at DailyMed

See drug prices for ZOLOFT

See drug sales revenues for ZOLOFT

Recent Clinical Trials for ZOLOFT

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	Phase 2
Unity Health Toronto	Phase 2
Queen's University	Phase 2

See all ZOLOFT clinical trials

Pharmacology for ZOLOFT

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for ZOLOFT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOLOFT	Tablets	sertraline hydrochloride	150 mg and 200 mg	019839	1	2005-11-09
ZOLOFT	Oral Concentrate	sertraline hydrochloride	20 mg/mL	020990	1	2003-12-09

US Patents and Regulatory Information for ZOLOFT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991	AB	RX	Yes	No
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-002	Dec 30, 1991	AB	RX	Yes	Yes
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-003	Dec 30, 1991		DISCN	Yes	No
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-004	Dec 30, 1991		DISCN	Yes	No
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-005	Mar 6, 1996	AB	RX	Yes	No
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999	AA	RX	Yes	Yes

Expired US Patents for ZOLOFT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-003	Dec 30, 1991
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-005	Mar 6, 1996
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-003	Dec 30, 1991
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-005	Mar 6, 1996

International Patents for ZOLOFT

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

Country	Patent Number	Title	Estimated Expiration
Australia	6571590
Bosnia and Herzegovina	97150
Canada	2029065	METHODE DE TRAITEMENT DES TROUBLES LIES A L'ANXIETE FAISANT APPEL A LA SERTRALINE (METHOD OF TREATING ANXIETY RELATED DISORDERS USING SERTRALINE)
Iceland	5906
Israel	96146	Use of sertraline for the preparation of medicaments for treating anxiety-related disorders
New Zealand	195407	CIS-4-PHENYL-1,2,3,4-TETRAHYDRO-1-NAPHTHALENAMINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
Peru	11082000

Supplementary Protection Certificates for ZOLOFT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0030081	93C0073	Belgium		PRODUCT NAME: SERTRALINI HYDROCHLORID; NAT. REG.: 241 IS 30 F 19901119; FIRST REG.: GB PL 0057/03 19901119
0030081	SPC/GB93/048	United Kingdom		SPC/GB93/048, EXPIRES: 20051027

The Economics and Market Dynamics of Zoloft (Sertraline)

Introduction

Zoloft, known generically as sertraline, is a widely prescribed selective serotonin reuptake inhibitor (SSRI) used to treat various mental health conditions, including depression, anxiety disorders, obsessive-compulsive disorder (OCD), and more. This article delves into the market dynamics and financial trajectory of Zoloft, exploring its medical uses, market trends, economic impact, and future projections.

Medical Uses of Zoloft

Zoloft is a prescription medication that functions by increasing the level of serotonergic activity in the brain, thereby improving mood and reducing anxiety. It is prescribed for a range of mental health conditions, including depression, anxiety disorders, OCD, panic attacks, and social anxiety[3][4].

The Market for Zoloft/Sertraline

The market for Zoloft is dynamic and involves multiple pharmaceutical companies. Pfizer, the original developer of Zoloft, remains a significant player, although the market is no longer dominated solely by brand-name manufacturers. The introduction of generic sertraline has significantly impacted market dynamics, contributing to price fluctuations and increased affordability for patients[1].

Key Players

Pfizer, despite facing challenges such as the loss of exclusivity for Zoloft in 2007, continues to be a major force in the market. Other key players include generic manufacturers that produce sertraline, making the medication more accessible and affordable[1][5].

Market Trends for Zoloft/Sertraline

The demand for Zoloft/Sertraline is driven by several factors:

Growing Demand for Antidepressants

The increasing prevalence of mental health conditions, such as depression and anxiety disorders, has led to a steady rise in prescription rates for Zoloft/Sertraline. This trend is further accelerated by the growing awareness of mental health issues and the reduced stigma surrounding mental illness[1][3][4].

Generic Alternatives

The availability of generic sertraline has brought about greater affordability and accessibility for patients. Generic versions tend to be more cost-effective than their brand-name counterparts, making treatment more accessible to a broader population[1][3].

Innovations and Research

Pharmaceutical companies are continuously exploring new formulations, delivery methods, and dosage options to enhance the effectiveness and convenience of Zoloft/Sertraline. Innovations such as repetitive Transcranial Magnetic Stimulation Therapy (rTMS) and other psychiatric treatments are also contributing to the market's growth[1][3].

Economic Impact of Zoloft/Sertraline

Role in the Pharmaceutical Industry

Zoloft has been a financial success for Pfizer and has spurred the development of other SSRIs. Its economic impact extends beyond sales figures, as it has revolutionized the treatment approach to mental health conditions, improving the overall well-being and productivity of individuals[1].

Public Health Economics

From a public health economics perspective, the widespread use of Zoloft/Sertraline reduces the burden on healthcare systems by decreasing the need for costly hospitalizations and treatments associated with uncontrolled mental illness. Improved mental well-being also translates to greater productivity and reduced absenteeism in the workforce[1].

Financial Trajectory of Zoloft

Historical Financial Performance

Pfizer's financial performance was significantly impacted by the loss of exclusivity for Zoloft in 2007. This led to a decline in revenues, with worldwide pharmaceutical revenues decreasing by 7% in the second quarter of 2007 compared to the previous year. However, excluding the revenues of Zoloft and Norvasc, Pfizer's pharmaceutical revenues grew by 3% in the same period[5].

Current Market Performance

The sertraline market is projected to expand at a Compound Annual Growth Rate (CAGR) of 3.90% from 2022 to 2029. This growth is driven by the rising prevalence of mental health disorders, increasing healthcare expenditure, and the growing demand for antidepressants. The market is also influenced by the availability of generic versions and innovations in drug formulations[3][4].

Future Projections for Zoloft/Sertraline

Predicted Market Changes

The future market for Zoloft/Sertraline is expected to witness continued growth driven by increasing mental health awareness globally and the diminishing stigma surrounding mental health. The trend towards generic alternatives is anticipated to continue, leading to further price reductions and greater affordability for patients[1][3].

Innovations and Digital Health

Innovations in drug formulations, the rise of personalized medicine, and the increasing role of telemedicine and digital health platforms are likely to further enhance the market's potential. These advancements will provide patients with a wider range of choices and improve treatment outcomes[3][4].

Key Takeaways

• Zoloft/Sertraline is a crucial medication in the treatment of various mental health conditions.
• The market is driven by growing demand for antidepressants, the availability of generic alternatives, and ongoing research and development.
• The economic impact of Zoloft/Sertraline includes reduced healthcare costs and improved productivity.
• The future market is expected to grow, driven by increasing mental health awareness and the integration of digital health solutions.

FAQs

What is Zoloft used for?

Zoloft, or sertraline, is used to treat various mental health conditions including depression, anxiety disorders, obsessive-compulsive disorder (OCD), panic attacks, and social anxiety[3][4].

Who are the key players in the Zoloft market?

Key players include Pfizer, the original developer of Zoloft, and various generic manufacturers that produce sertraline[1][5].

How has the introduction of generic sertraline impacted the market?

The introduction of generic sertraline has made the medication more affordable and accessible, contributing to price fluctuations and increased market competition[1].

What are the future projections for the Zoloft market?

The market is expected to grow, driven by increasing mental health awareness, the availability of generic alternatives, and innovations in drug formulations and digital health solutions[1][3].

How does Zoloft impact public health economics?

Zoloft reduces the burden on healthcare systems by decreasing the need for costly hospitalizations and treatments associated with uncontrolled mental illness, and improves productivity and reduces absenteeism in the workforce[1].

Sources

1. The Economics of Zoloft/Sertraline - Cabinet Health
2. 10 of the Largest Pharmaceutical Companies by Revenue - TechTarget
3. Sertraline Market Projected to Expand at 3.90% CAGR from 2022 - OpenPR
4. Rising Demand for Sertraline: Market Dynamics, Key Players, and Future Projections - Market Research Intellect
5. Pfizer Reports Second-Quarter 2007 Results - Pfizer Press Release