SEROQUEL Drug Patent Profile

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

Seroquel is a drug marketed by Astrazeneca and is included in two NDAs.

The generic ingredient in SEROQUEL is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Seroquel

A generic version of SEROQUEL was approved as quetiapine fumarate by ACCORD HLTHCARE on March 27^th, 2012.

Summary for SEROQUEL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	192
Patent Applications:	5,583
Drug Prices:	Drug price information for SEROQUEL
Drug Sales Revenues:	Drug sales revenues for SEROQUEL
What excipients (inactive ingredients) are in SEROQUEL?	SEROQUEL excipients list
DailyMed Link:	SEROQUEL at DailyMed

See drug prices for SEROQUEL

See drug sales revenues for SEROQUEL

Recent Clinical Trials for SEROQUEL

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

Sponsor	Phase
Ain Shams University	N/A
University of Miami	Phase 4
Alzheimer's Association	Phase 4

See all SEROQUEL clinical trials

Pharmacology for SEROQUEL

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for SEROQUEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 SEROQUEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-001	Sep 26, 1997	AB	RX	Yes	Yes
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-006	Oct 4, 2005	AB	RX	Yes	No
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-004	Dec 20, 1998		DISCN	Yes	No
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	AB	RX	Yes	No
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	AB	RX	Yes	No
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-007	Oct 4, 2005	AB	RX	Yes	No

Expired US Patents for SEROQUEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-006	Oct 4, 2005
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-001	Sep 26, 1997
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-005	Jul 26, 2000
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-003	Sep 26, 1997
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-004	Dec 20, 1998
Astrazeneca	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-007	Oct 4, 2005

International Patents for SEROQUEL

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

Country	Patent Number	Title	Estimated Expiration
Canada	1288428	COMPOSES DE THIAZEPINE (THIAZEPINE COMPOUNDS)
South Korea	900001868
Denmark	174618
Japan	S638378	DIBENZOTHIAZEPINE COMPOUND, MANUFACTURE AND PHARMACEUTICAL COMPOSITION HAVING ANTIPSYCHOTIC AND NEUROLEPTIC ACTIVITY
Austria	58132
Australia	593336

Supplementary Protection Certificates for SEROQUEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0240228	SPC/GB97/086	United Kingdom		PRODUCT NAME: QUETIAPINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: UK 12619/0112 19970731; UK 12619/0113 19970731; UK 12619/0114 19970731
0240228	C980022	Netherlands		PRODUCT NAME: QUETIAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT, IN HET BIJZONDER QUETIAPINEFUMARAAT; NAT. REGISTRATION NO/DATE: RVG 20826 - RVG 20828 19980427; FIRST REGISTRATION: GB PL 12619/0112 - PL 12619/0114 19970731
0240228	2000C/015	Belgium		PRODUCT NAME: QUETIAPINE FUMARAT (EQUIV. MET 25MG QUETIAPINE BASE); REGISTRATION NO/DATE: 624 S 309 F 3 20000207; FIRST REGISTRATION: GB PL 12619/0113 19970731
0240228	9/2000	Austria		PRODUCT NAME: QUETIAPIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ZULAESSIGEN SALZES; NAT. REGISTRATION NO/DATE: 1-23460, 1-23461 1-23463 20000113; FIRST REGISTRATION: GB 12619/0112 - 12619/0114 19970731

SEROQUEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Seroquel

Introduction

Seroquel, also known as quetiapine fumarate, is an atypical antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and in some cases, major depressive disorder and generalized anxiety disorder. This article delves into the market dynamics and financial trajectory of Seroquel, highlighting key events, market trends, and financial implications.

Historical Sales and Revenue

Seroquel has been a significant revenue generator for AstraZeneca. In 2017, Seroquel and Seroquel XR generated annual sales of $85 million and $63 million, respectively, in the markets covered by an agreement with Luye Pharma Group[5]. In 2018, the sales figures for Seroquel and Seroquel XR in the US and Canada were $36 million and $79 million, respectively[1].

Patent Expiry and Generic Competition

A critical factor influencing the financial trajectory of Seroquel is the expiry of its patent protection. The main patent for Seroquel expired in October 2011, and the pediatric coverage patent expired in March 2010. This has led to the entry of generic formulations, significantly impacting the market dynamics and pricing of the drug[2][4].

Divestment and Licensing Agreements

AstraZeneca has divested the commercial rights to Seroquel and Seroquel XR in various markets to focus on its main therapy areas. In 2019, AstraZeneca sold the commercial rights to these drugs in the US and Canada to Cheplapharm, following similar divestments in other international markets, including the UK, Japan, Europe, and Russia[1][5]. These agreements typically involve upfront payments and potential future sales-contingent payments. For example, the deal with Cheplapharm included an upfront payment of $35 million and up to $6 million in future sales-contingent payments[1].

Litigation and Settlements

Seroquel has been involved in significant product liability litigation, particularly in the US. In 2010, AstraZeneca agreed to pay $198 million to settle lawsuits related to the drug's association with an increased risk of diabetes. This settlement resolved over 10,000 lawsuits and provided a sense of resolution for the company, although it did not impact its core earnings-per-share guidance[2].

Market Growth Drivers

Despite the challenges posed by generic competition and litigation, the quetiapine market is expected to grow. Key drivers include:

• Increasing Prevalence of Mental Health Disorders: The rising prevalence of schizophrenia, bipolar disorder, and depression globally drives demand for effective treatments like quetiapine[4].
• Growing Awareness and Acceptance: Increased awareness and reduced stigma associated with mental health conditions have led more patients to seek treatment, boosting the market for antipsychotic medications[4].
• Aging Population: The global aging population contributes to an increase in age-related mental health issues, further driving demand for psychiatric medications[4].

Market Challenges

Several challenges impact the market dynamics and financial trajectory of Seroquel:

• Generic Competition: The entry of generic versions has reduced prices and profit margins for branded products[4].
• Safety Concerns and Side Effects: Reports of side effects such as metabolic issues, sedation, and potential cardiovascular problems can reduce prescriptions and physician confidence in the drug[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].
• Market Saturation: The competitive antipsychotic market, with numerous alternatives available, limits the market potential for Seroquel[4].

Financial Implications

The financial implications of these market dynamics are multifaceted:

• Revenue Impact: The loss of patent protection and subsequent generic competition have significantly reduced the revenue generated by Seroquel for AstraZeneca[1][2][4].
• Divestment Proceeds: The divestment of commercial rights has provided AstraZeneca with upfront payments and potential future earnings, which are reported as Other Operating Income in their financial statements[1][5].
• Litigation Costs: The settlement of product liability lawsuits, such as the $198 million payout in 2010, has been a significant financial burden, although it did not alter the company's core earnings-per-share guidance[2].

Regional Market Dynamics

The market for quetiapine varies by region:

• Asia-Pacific: Rapid urbanization, growing population awareness of mental health, and increasing healthcare spending are fostering market growth, though access to medications can vary widely among countries[4].
• Middle East and Africa: Limited access to healthcare and varying degrees of pharmaceutical regulations present unique challenges, but there is a gradual increase in demand due to heightened recognition of mental health issues[4].

Future Outlook

The quetiapine market is projected to grow at a CAGR of 5.2% from 2024 to 2031, reaching a market size of USD 26.45 billion by 2031. This growth is driven by increasing mental health disorders, growing awareness and acceptance of mental health issues, and ongoing research and development in psychiatric medications[4].

Key Takeaways

• Seroquel has been a significant revenue generator for AstraZeneca but faces challenges due to patent expiry and generic competition.
• Divestment agreements have provided AstraZeneca with financial benefits while allowing continued patient access to the medication.
• The market is driven by increasing mental health disorders and growing awareness, but faces challenges such as safety concerns and regulatory hurdles.
• The quetiapine market is expected to grow, driven by global demand for effective psychiatric treatments.

FAQs

What are the primary indications for Seroquel?

Seroquel is primarily used to treat schizophrenia and bipolar disorder. It is also approved in some markets for major depressive disorder and generalized anxiety disorder[1].

How has the patent expiry affected Seroquel's market dynamics?

The expiry of Seroquel's patent protection has led to the entry of generic formulations, significantly reducing prices and profit margins for branded products[2][4].

What were the financial implications of the 2010 litigation settlement?

AstraZeneca agreed to pay $198 million to settle product liability lawsuits related to Seroquel, which did not impact the company's core earnings-per-share guidance[2].

How does the aging population influence the demand for Seroquel?

The global aging population contributes to an increase in age-related mental health issues, driving demand for psychiatric medications like Seroquel[4].

What is the projected growth rate of the quetiapine market?

The quetiapine market is projected to grow at a CAGR of 5.2% from 2024 to 2031, reaching a market size of USD 26.45 billion by 2031[4].

Sources

1. AstraZeneca Press Release: AstraZeneca divests rights to Seroquel and Seroquel XR in the US and Canada[1].
2. S&P Global Market Intelligence: AstraZeneca to Pay US$198 Mil. to Settle Seroquel Litigation[2].
3. Fact.MR: Psychotic Disorder Treatment Market Growth Impelled by Growing Cases of Mental Disturbances[3].
4. Verified Market Research: Quetiapine Market Size, Share, Scope, Trends & Forecast[4].
5. AstraZeneca Press Release: AstraZeneca and Luye Pharma Group enter agreement for rights to Seroquel and Seroquel XR in the UK, China, and other international markets[5].