SEROQUEL Drug Patent Profile

When do Seroquel patents expire, and when can generic versions of Seroquel launch?

Seroquel is a drug marketed by Cheplapharm 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 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

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
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-001	Sep 26, 1997	AB	RX	Yes	Yes
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-006	Oct 4, 2005	AB	RX	Yes	No
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-004	Dec 20, 1998		DISCN	Yes	No
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	AB	RX	Yes	No

International Patents for SEROQUEL

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

Country	Patent Number	Title	Estimated Expiration
Spain	2019379
United Kingdom	8706949
Germany	3765969
South Korea	900001868

Supplementary Protection Certificates for SEROQUEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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

SEROQUEL (Quetiapine) Investment and Fundamentals Analysis

Last updated: February 20, 2026

What is the current market profile of SEROQUEL?

SEROQUEL (quetiapine) is an atypical antipsychotic developed by AstraZeneca. It is primarily indicated for schizophrenia, bipolar disorder, and major depressive disorder (adjunctive therapy). As of 2022, it remains one of the top-prescribed atypical antipsychotics globally, with a significant revenue contribution from the psychiatric segment.

Market size and revenue trends

Year	Global Sales (USD billion)	Growth Rate	Key Markets
2021	2.5	3%	U.S., Europe, Japan
2022	2.6	4%	U.S. retains largest share, followed by Europe

Note: Sales driven mainly by prescribability in schizophrenia and bipolar disorder. The drug's patent expiration in several markets has led to increased generic competition, impacting revenue.

Patent and regulatory landscape

• Patent Timeline: Original patents expired in the U.S. in 2017, with several formulations losing exclusivity globally by 2019.
• Regulatory Approvals: Approved for schizophrenia in 1997; for bipolar disorder in 2004; for major depressive disorder in 2008.
• Generic Competition: Several generics gained FDA approval post-2017, significantly reducing pricing power and profit margins.

Manufacturing and supply chain considerations

• Manufacturing: Complex synthesis process with active pharmaceutical ingredient (API) in high demand for generics.
• Supply Chain Risks: Reliance on China and India for API production exposes the supply to geopolitical disruptions and raw material shortages.

Competitive landscape

Competitor	Key Drugs	Market Share (2022)	Patent Status
Johnson & Johnson	Risperdal, Invega	20%	Patented products
Novartis	Clozaril (clozapine)	12%	Patent expired
Teva	Generic quetiapine formulations	8%	No patent protection

The entry of generics has constrained price escalation. branded sales rely heavily on physicians' brand preference.

Clinical and safety profile

• Efficacy: Proven effective for schizophrenia and bipolar disorder; not approved as a first-line treatment due to side effect profile.
• Adverse effects: Weight gain, metabolic syndrome, sedation, and extrapyramidal symptoms.
• Regulatory safety concerns: FDA boxed warning for increased mortality in elderly patients with dementia-related psychosis.

Investment considerations

1. Revenue impact from generics: Loss of market exclusivity significantly cut sales post-2017; future revenue depends on off-label uses and the potential for new formulations.
2. Pipeline prospects: AstraZeneca has explored extended-release formulations and combination therapies, though no recent major updates are noted.
3. Market vulnerabilities: Rising competition from generic manufacturers and generics from multiple players.

Financial performance (2022)

Metric	Value
Total Revenue	USD 17.9 billion
Psychiatry segment	USD 2.6 billion (SEROQUEL contributed)
Operating Margin	30%

Revenue decline from older formulations signals a need to diversify or innovate within the therapeutic area.

Strategic outlook

• Short-term: Focus on cost management, optimizing generics sales, and expanding into emerging markets.
• Medium-term: Development of new formulations or combination drugs to extend lifecycle.
• Long-term: Addressing unmet needs such as treatment-resistant schizophrenia or novel therapeutic targets.

Key risks and opportunities

Risks	Opportunities
Patent expiration effects	Introduction of new formulations or delivery systems
Competition from generics	Expanding into niche indications and off-label uses
Safety and regulatory changes	Partnering with biotech firms for novel psychotropic agents

Key takeaways

• SEROQUEL's revenue has declined due to patent loss, with brands facing intense generic competition.
• The company’s future growth hinges on pipeline innovation and strategic market expansion.
• Market dynamics favor generic manufacturers, suppressing pricing and margins.
• Clinical safety concerns limit broader use, but current approvals maintain stable demand in core indications.
• Supply chain risks for APIs and geopolitical factors could influence manufacturing costs.

FAQs

1. What is the primary driver of SEROQUEL sales decline?
   Loss of patent exclusivity leading to generic competition in 2017 reduced branded sales significantly.

2. Are there any new formulations or indications in development?
   No significant pipeline updates are available as of 2023; focus remains on optimizing existing formulations.

3. How does the safety profile influence market acceptance?
   Boxed warnings and adverse side effects restrict use to specific patient populations and limit broader prescribing.

4. What are the key factors affecting supply chain stability?
   API sourcing from China and India exposes production to geopolitical and raw material risks.

5. How does the competitive landscape affect profitability?
   Generic competition limits pricing power; market share shifts toward manufacturers of low-cost formulations.

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References

[1] IQVIA. (2022). Global Prescription Drug Market Data.
[2] AstraZeneca. (2023). Annual Report 2022.
[3] FDA. (2023). Drug Approvals and Labeling.
[4] Market Research Future. (2022). Global Psychiatry Drugs Market Analysis.
[5] U.S. Patent and Trademark Office. (2019). Patent Expiry Schedule for Quetiapine.