Quetiapine fumarate - Generic Drug Details

What are the generic sources for quetiapine fumarate and what is the scope of freedom to operate?

Quetiapine fumarate is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Astrazeneca, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-eight drug master file entries for quetiapine fumarate. Fifty-one suppliers are listed for this compound.

Summary for quetiapine fumarate

US Patents:	0
Tradenames:	3
Applicants:	29
NDAs:	39
Drug Master File Entries:	48
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	207
Clinical Trials:	97
Patent Applications:	4,253
Drug Prices:	Drug price trends for quetiapine fumarate
Drug Sales Revenues:	Drug sales revenues for quetiapine fumarate
What excipients (inactive ingredients) are in quetiapine fumarate?	quetiapine fumarate excipients list
DailyMed Link:	quetiapine fumarate at DailyMed

See drug prices for quetiapine fumarate

See drug sales revenues for quetiapine fumarate

Recent Clinical Trials for quetiapine fumarate

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

Sponsor	Phase
The University of Texas Health Science Center at San Antonio	Early Phase 1
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all quetiapine fumarate clinical trials

Pharmacology for quetiapine fumarate

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for quetiapine fumarate

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for quetiapine fumarate

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for QUETIAPINE FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SEROQUEL XR	Extended-release Tablets	quetiapine fumarate	150 mg	022047	1	2008-11-17
SEROQUEL XR	Extended-release Tablets	quetiapine fumarate	50 mg	022047	1	2008-10-17
SEROQUEL XR	Extended-release Tablets	quetiapine fumarate	400 mg	022047	1	2008-06-18
SEROQUEL XR	Extended-release Tablets	quetiapine fumarate	200 mg and 300 mg	022047	1	2008-06-12
SEROQUEL	Tablets	quetiapine fumarate	50 mg, 150 mg and 400 mg	020639	1	2007-02-12
SEROQUEL	Tablets	quetiapine fumarate	100 mg, 200 mg and 300 mg	020639	1	2006-02-21
SEROQUEL	Tablets	quetiapine fumarate	25 mg	020639	1	2005-08-12

US Patents and Regulatory Information for quetiapine fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipca Labs Ltd	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	205983-002	May 20, 2024	AB	RX	No	No
Teva Pharms	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	077745-004	Mar 27, 2012	AB	RX	No	No
Endo Operations	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	090482-002	May 9, 2017		DISCN	No	No
Macleods Pharms Ltd	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	203359-003	May 17, 2016	AB	RX	No	No
Aurobindo Pharma Ltd	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	091388-005	Mar 27, 2012	AB	RX	No	No
Alkem Labs Ltd	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	201504-001	Feb 12, 2013	AB	RX	No	No

Expired US Patents for quetiapine fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	5,948,437*PED
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-006	Oct 4, 2005	4,879,288*PED
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-004	Dec 20, 1998	4,879,288*PED
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-002	May 17, 2007	4,879,288*PED
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	4,879,288*PED
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	4,879,288*PED

Quetiapine fumarate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quetiapine Fumarate

Introduction

Quetiapine fumarate, marketed under the brand name Seroquel among others, is an atypical antipsychotic medication used primarily to treat mental health conditions such as schizophrenia, bipolar disorder, and major depressive disorder. Here, we delve into the market dynamics and financial trajectory of quetiapine fumarate, exploring its current state, future projections, and the factors influencing its market performance.

Current Market Size and Forecast

The global quetiapine market is substantial, with varying forecasts depending on the specific segment being analyzed. As of 2023, the quetiapine market was valued at USD 16.11 billion and is projected to reach USD 26.45 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period from 2024 to 2031[4].

However, when focusing specifically on the quetiapine fumarate market, the projections are slightly different. The global quetiapine fumarate market is expected to decline from USD 155.9 million in 2024 to USD 136.4 million by 2030, at a CAGR of -2.2% during the forecast period[1].

Market Drivers

Several key factors drive the demand for quetiapine fumarate:

Increase in Mental Health Disorders

The rising prevalence of mental health disorders such as schizophrenia, bipolar disorder, and depression globally increases the demand for effective treatments like quetiapine fumarate[4].

Awareness and Acceptance of Mental Health Issues

Growing awareness and reduced stigma associated with mental health conditions lead more patients to seek treatment, boosting the market for antipsychotic medications[4].

Aging Population

The aging population contributes to an increase in age-related mental health issues, thereby increasing the demand for psychiatric medications[4].

Research and Development

Ongoing research and clinical trials exploring new therapeutic uses for quetiapine or combinations with other treatments can expand its application and market potential[4].

Market Challenges

Despite the drivers, the quetiapine fumarate market faces several challenges:

Generic Competition

The expiration of patents for branded versions of quetiapine has led to the entry of generic formulations, which can increase accessibility but also exert pressure on prices and profit margins for branded products[4].

Regulatory Challenges

Stricter regulations and longer approval times for new drug formulations or indications can impede market entry for new competitors or innovations[4].

Safety Concerns and Side Effects

Reports of side effects related to quetiapine, such as metabolic issues (weight gain, diabetes risk), sedation, and potential cardiovascular problems, can lead to reduced prescriptions and physician hesitance to recommend the drug[4][5].

Market Saturation

The antipsychotic market is highly competitive, with numerous alternatives available, which can limit the market potential for quetiapine fumarate[4].

Distribution Channels

The quetiapine market is distributed through several key channels:

Hospital Pharmacies

Hospital pharmacies are a significant distribution channel, especially for patients undergoing inpatient treatment for mental health conditions[4].

Retail Pharmacies

Retail pharmacies provide widespread access to quetiapine fumarate, making it readily available to patients with prescriptions[4].

Online Pharmacies

Online pharmacies offer convenience and sometimes lower prices, contributing to the market reach of quetiapine fumarate[4].

Geographical Analysis

The quetiapine market varies significantly by region:

North America

North America, particularly the United States, has a high prevalence of psychiatric disorders and a well-established pharmaceutical sector, leading to substantial demand for antipsychotic drugs[4].

Europe

Europe is characterized by diverse healthcare systems and increasing awareness of mental health, driving the adoption of quetiapine. Europe is actually the largest market for quetiapine fumarate, accounting for about 92% of the market share[1].

Asia-Pacific

The Asia-Pacific region presents a growing market due to rapid urbanization, increasing population awareness of mental health, and rising healthcare spending. However, access to medications can vary widely among countries[4].

Middle East and Africa

In the Middle East and Africa, the market faces challenges such as limited access to healthcare and varying degrees of pharmaceutical regulations, but there is a gradual increase in demand due to heightened recognition of mental health issues[4].

Key Players

The quetiapine fumarate market is dominated by several key players:

• TAPI
• Accord
• Hexal
• Dr.Reddy's
• Lupin
• Sun Pharmaceutical
• Hunan Dongting Pharm
• SuZhou NO.4 Pharmaceutical Factory
• Fuan Pharmaceutical
• Zhejiang Supor Pharmaceuticals
• Zhejiang Huahai Pharmaceutical[1]

These companies occupy a significant market share, with the top three companies accounting for about 74% of the market[1].

Mechanism of Action and Therapeutic Uses

Quetiapine fumarate acts as a 5-HT2A receptor antagonist and a D2 receptor antagonist, making it effective in treating a range of mental health conditions. It was initially developed by AstraZeneca Pharmaceuticals Co. and has been approved for various indications, including schizophrenia, bipolar disorder, and major depressive disorder[3].

Safety and Side Effects

While quetiapine fumarate is effective, it comes with several potential side effects and safety concerns. These include weight gain, metabolic changes, sedation, and potential cardiovascular problems. Long-term use can also lead to lens changes and cerebrovascular adverse events, particularly in elderly patients with dementia-related psychoses[2][5].

Abuse and Misuse

There have been reports of quetiapine fumarate abuse, particularly in prison and inpatient psychiatric populations. The sedating effects of the drug are hypothesized to contribute to its abuse potential[5].

Financial Trajectory

The financial trajectory of the quetiapine fumarate market is complex, with both declining and growing trends depending on the specific segment.

• Declining Segment: The global quetiapine fumarate market is expected to decline from USD 155.9 million in 2024 to USD 136.4 million by 2030, at a CAGR of -2.2%[1].
• Growing Segment: However, the broader quetiapine market is projected to grow from USD 16.11 billion in 2023 to USD 26.45 billion by 2031, at a CAGR of 5.2%[4].

Key Takeaways

• The quetiapine fumarate market faces a decline in the specific segment but growth in the broader quetiapine market.
• Key drivers include increasing mental health disorders, growing awareness, and an aging population.
• Challenges such as generic competition, regulatory hurdles, and safety concerns impact the market.
• Distribution channels include hospital, retail, and online pharmacies.
• The market is geographically diverse, with Europe being the largest market for quetiapine fumarate.

FAQs

Q: What is the projected market size of the quetiapine fumarate market by 2030? A: The global quetiapine fumarate market is projected to be USD 136.4 million by 2030[1].

Q: What are the main therapeutic uses of quetiapine fumarate? A: Quetiapine fumarate is used primarily to treat schizophrenia, bipolar disorder, and major depressive disorder[3].

Q: Which region has the largest market share for quetiapine fumarate? A: Europe has the largest market share for quetiapine fumarate, accounting for about 92% of the market[1].

Q: What are some of the potential side effects of quetiapine fumarate? A: Potential side effects include weight gain, metabolic changes, sedation, and potential cardiovascular problems[2][5].

Q: Is quetiapine fumarate subject to abuse? A: Yes, there have been reports of quetiapine fumarate abuse, particularly in prison and inpatient psychiatric populations[5].

Cited Sources

1. Global Quetiapine Fumarate Market Insights, Forecast to 2030 - Valuates Reports
2. Seroquel (quetiapine fumarate) and Seroquel XR Safety and Drug Utilization Review - FDA
3. Quetiapine Fumarate - Drug Targets, Indications, Patents - Synapse
4. Quetiapine Market Size, Share, Scope, Trends & Forecast - Verified Market Research
5. Side Effects of Seroquel (Quetiapine) - Greenhouse Treatment Center