SERTRALINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for sertraline hydrochloride and what is the scope of freedom to operate?

Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Almatica, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Viatris, Accord Hlthcare, Anda Repository, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Norvium Bioscience, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for sertraline hydrochloride. Forty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for SERTRALINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	26
NDAs:	33
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	329
Patent Applications:	7,021
What excipients (inactive ingredients) are in SERTRALINE HYDROCHLORIDE?	SERTRALINE HYDROCHLORIDE excipients list
DailyMed Link:	SERTRALINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for SERTRALINE HYDROCHLORIDE

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

Sponsor	Phase
Azrieli Foundation	Phase 2
The Hospital for Sick Children	Phase 2
Ontario Brain Institute	Phase 2

See all SERTRALINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for SERTRALINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 100MG BASE	TABLET;ORAL
		EQ 50MG BASE	TABLET;ORAL
		EQ 25MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SERTRALINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for SERTRALINE HYDROCHLORIDE

Antidepressive Agents

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SERTRALINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for SERTRALINE HYDROCHLORIDE

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 SERTRALINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Appco	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	077713-003	Feb 6, 2007		DISCN	No	No
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991	AB	RX	Yes	No
Strides Pharma	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	076881-002	Feb 6, 2007	AB	RX	No	No
Reyoung	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	078677-002	Mar 4, 2009	AB	RX	No	No
Sciegen Pharms Inc	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	076442-003	Apr 30, 2007	AB	RX	No	No
Appco	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	TABLET;ORAL	077713-002	Feb 6, 2007		DISCN	No	No
Ranbaxy Labs Ltd	SERTRALINE HYDROCHLORIDE	sertraline hydrochloride	CONCENTRATE;ORAL	078053-001	Feb 5, 2007		DISCN	No	No

Expired US Patents for SERTRALINE HYDROCHLORIDE

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	019839-002	Dec 30, 1991
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-003	Dec 30, 1991
Viatris	ZOLOFT	sertraline hydrochloride	TABLET;ORAL	019839-001	Dec 30, 1991
Viatris	ZOLOFT	sertraline hydrochloride	CONCENTRATE;ORAL	020990-001	Dec 7, 1999

SERTRALINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sertraline Hydrochloride

Introduction to Sertraline Hydrochloride

Sertraline hydrochloride, commonly known by the brand name Zoloft, is a selective serotonin reuptake inhibitor (SSRI) widely prescribed for the treatment of various mental health conditions, including depression, anxiety disorders, obsessive-compulsive disorder (OCD), panic attacks, and social anxiety. The drug's effectiveness and growing demand have made it a significant player in the pharmaceutical market.

Growing Demand and Market Drivers

The demand for sertraline hydrochloride has been steadily increasing over the past decade, driven by several key factors:

Rising Prevalence of Mental Health Issues

The global rise in mental health disorders, such as depression and anxiety, is a major driver of the sertraline market. Urbanization and increased stress levels in both personal and professional lives have contributed to this surge. The COVID-19 pandemic has further exacerbated mental health problems, leading to a higher need for psychiatric treatments like sertraline[1][4][5].

Increasing Awareness and Acceptance of Mental Health

As societies become more open to discussions about mental health, the stigma surrounding mental illnesses is diminishing. This increased awareness and acceptance have encouraged more people to seek help, thereby driving the demand for mental health services and medications like sertraline[1][5].

Government Initiatives and Public Campaigns

Government initiatives, public campaigns, and efforts by healthcare providers to reduce the stigma around mental illnesses have also contributed to the growing demand for sertraline. These initiatives have made mental health care more accessible and encouraged individuals to seek treatment[1].

Market Dynamics

Competitive Landscape

The sertraline market is highly competitive, with major pharmaceutical companies like Pfizer Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, and Accord Biopharma playing significant roles. These companies manufacture both branded and generic versions of sertraline, with generic manufacturers offering affordable alternatives that have expanded the market reach[1][4][5].

Research and Development

Key players in the market are focusing on research and development to improve the efficacy of sertraline and to develop new formulations. Strategic partnerships are also crucial for expanding market reach and enhancing the drug's accessibility[1][4].

Regulatory Influence

Regulatory bodies play a vital role in ensuring the safety and efficacy of sertraline, influencing market dynamics through strict guidelines and approvals. This ensures that only safe and effective treatments are available to patients[1].

Financial Trajectory

Current Market Size and Growth

The global sertraline hydrochloride market was valued at approximately $1.385 billion in 2022 and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 7.1% from 2024 to 2031. This growth is driven by the increasing prevalence of mental health disorders, the availability of generic versions, and innovations in drug formulations[4].

Revenue Forecasts

The market is projected to reach significant revenue by 2031, driven by the growing demand for mental health care, the increasing availability of generic versions, and the integration of digital health platforms. The global focus on mental health and the rising awareness about mental well-being are key factors supporting this growth[1][3][4].

Cost Implications and Affordability

The cost of sertraline can vary based on dosage and quantity. Purchasing larger quantities often results in a lower per-unit cost, making long-term treatment more cost-effective. The trend towards generic alternatives is expected to continue, leading to further price reductions and greater affordability for patients[5].

Economic Impact

Role in the Pharmaceutical Industry

Sertraline has revolutionized the treatment approach to mental health conditions, contributing significantly to the financial success of pharmaceutical companies like Pfizer. Its success has also spurred the development of other SSRIs, impacting the broader pharmaceutical industry[5].

Public Health Economics

From a public health economics perspective, the widespread use of 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[5].

Future Projections

Continued Growth

The market for sertraline is expected to continue growing as mental health awareness expands globally and the stigma surrounding mental health diminishes. 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[1][4][5].

Emerging Trends and Alternatives

The future may see the emergence of alternative treatment options for mental health conditions, such as other classes of antidepressants or non-pharmacological therapies. However, the long-standing track record and widespread acceptance of sertraline suggest that any potential impact from alternatives may take time to materialize[5].

Key Takeaways

• The sertraline hydrochloride market is driven by the rising prevalence of mental health issues, increasing awareness and acceptance of mental health, and government initiatives.
• The market is highly competitive with major pharmaceutical companies and generic manufacturers.
• Research and development, strategic partnerships, and regulatory influence are crucial for market dynamics.
• The market is expected to grow significantly, driven by increasing demand, generic availability, and innovations in drug formulations.
• Sertraline has a significant economic impact by reducing healthcare costs and improving productivity.

FAQs

What are the primary uses of sertraline hydrochloride?

Sertraline hydrochloride is primarily used to treat depression, anxiety disorders, obsessive-compulsive disorder (OCD), panic attacks, and social anxiety[1][2][5].

What factors are driving the growth of the sertraline market?

The growth of the sertraline market is driven by the rising prevalence of mental health issues, increasing awareness and acceptance of mental health, government initiatives, and the COVID-19 pandemic[1][4][5].

Who are the key players in the sertraline market?

Key players include major pharmaceutical companies like Pfizer Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, and Accord Biopharma, as well as generic manufacturers[1][4][5].

How is the cost of sertraline affected by dosage and quantity?

The cost of sertraline can be reduced by purchasing larger quantities, which often results in a lower per-unit cost, making long-term treatment more cost-effective[5].

What are the future projections for the sertraline market?

The market is expected to continue growing due to increasing mental health awareness, the rise of generic alternatives, innovations in drug formulations, and the integration of digital health platforms[1][4][5].

Sources

1. Market Research Intellect: Rising Demand for Sertraline: Market Dynamics, Key Players, and Future Projections.
2. Synapse by PatSnap: Sertraline Hydrochloride - Drug Targets, Indications, Patents.
3. Market Research Intellect: Global Sertraline HCl API Market Size, Scope And Forecast Report.
4. OpenPR: Sertraline Hcl Market Trends and Insights: A 2031 Forecast of the Global Market.
5. Cabinet Health: The Economics of Zoloft/Sertraline.