SEROQUEL XR Drug Patent Profile

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

Seroquel Xr is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in SEROQUEL XR 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 Xr

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

Summary for SEROQUEL XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	192
Patent Applications:	2,335
Drug Prices:	Drug price information for SEROQUEL XR
DailyMed Link:	SEROQUEL XR at DailyMed

See drug prices for SEROQUEL XR

See drug sales revenues for SEROQUEL XR

Recent Clinical Trials for SEROQUEL XR

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 XR clinical trials

Pharmacology for SEROQUEL XR

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for SEROQUEL XR

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

US Patents and Regulatory Information for SEROQUEL XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	AB	RX	Yes	No
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-003	May 17, 2007	AB	RX	Yes	No
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-005	Aug 11, 2008	AB	RX	Yes	No

Expired US Patents for SEROQUEL XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-003	May 17, 2007	5,948,437*PED
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	5,948,437*PED
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	4,879,288*PED

International Patents for SEROQUEL XR

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

Country	Patent Number	Title	Estimated Expiration
Ireland	59864	Thiazepine compounds
Luxembourg	90593
Japan	H064606

Supplementary Protection Certificates for SEROQUEL XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Market Dynamics and Financial Trajectory for SEROQUEL XR

Last updated: November 20, 2025

Introduction

SEROQUEL XR (quetiapine fumarate extended-release) stands as a prominent atypical antipsychotic medication developed by AstraZeneca, primarily approved for treating schizophrenia and bipolar I disorder. Over recent years, the medication's market landscape has experienced significant shifts driven by evolving clinical guidelines, competitive pressures, regulatory developments, and broader healthcare dynamics. This analysis delineates the current market environment, from demand drivers to financial performance, highlighting trends shaping SEROQUEL XR's trajectory.

Market Overview and Demand Drivers

Therapeutic Indications and Patient Demographics

SEROQUEL XR addresses two major psychiatric conditions: schizophrenia and bipolar disorder, both of which impact millions globally. According to the World Health Organization, schizophrenia affects approximately 20 million people worldwide [1], while bipolar disorder has an estimated prevalence of 45 million globally [2]. The rising recognition of mental health issues, coupled with increased diagnoses and long-term management adoption, fuels demand for effective pharmacotherapies like SEROQUEL XR.

Advantages Over Immediate-Release Formulations

The extended-release formulation offers improved pharmacokinetics, lessening dosing frequency and potentially enhancing patient adherence—a critical factor in psychiatric treatment outcomes. The convenience associated with once-daily dosing has supported its prescription preferences within clinical practice.

Line Extension and Off-Label Use

While SEROQUEL XR’s primary indications remain schizophrenia and bipolar disorder, off-label prescribing for conditions like agitation or certain anxiety disorders also influences demand dynamics, although these uses face regulatory and safety considerations.

Competitive Landscape

Key Competitors

The market for second-generation antipsychotics is crowded, featuring drugs like risperidone (RISPERDAL), aripiprazole (ABILIFY), olanzapine (ZYPREXA), and newer entrants like brexpiprazole and cariprazine. Each competitor offers distinct efficacy profiles, side effect spectra, and dosing paradigms that influence prescribing trends.

Market Share Trends

While SEROQUEL XR historically commanded substantial market share upon launch, recent years have seen erosion due to generic competition for the immediate-release version, as well as the rise of newer agents with improved safety profiles. Notably, patent expirations and bioequivalence approvals have facilitated generic entry, intensifying price competition.

Impact of Generic Penetration

The expiration of the SEROQUEL XR patent in 2020 led to a significant drop in branded sales, with generics now capturing a substantial portion. However, proprietary formulations and branded marketing continue to sustain a niche segment, particularly within managed care settings valuing formulation-specific benefits.

Regulatory and Reimbursement Factors

FDA Classifications and Approvals

SEROQUEL XR has received FDA approval primarily for schizophrenia and bipolar disorder. Regulatory approvals outside the U.S. are limited, influencing global sales strategies.

Reimbursement Trends

Insurance coverage substantially impacts prescription volumes. Cost-sharing and formulary placements favor generic versions, while branded SEROQUEL XR benefits from formulary exclusivity in certain managed care plans, fostering initial brand loyalty.

Financial Trajectory: Revenue Trends and Outlook

Historical Sales Performance

AstraZeneca reported peak sales of SEROQUEL XR around $1.5 billion in 2016, with subsequent declines post-patent expiry. The 2021 branded revenue for SEROQUEL XR in the U.S. was approximately $400 million, illustrating a sharp decline from peak levels due to generic competition and market saturation [3].

Current Market Valuation

Branded SEROQUEL XR’s revenues now represent a minor fraction of AstraZeneca’s total psychiatric portfolio. Post-patent, the financial performance has stabilized at lower levels, primarily driven by niche markets and formulary exclusivity.

Future Revenue Projections

Forecasts suggest that SEROQUEL XR’s revenue will decline further, aligning with the generic-drug lifecycle. However, initiatives focusing on combination therapy, niche indications, and improved formulations could prolong product relevance.

Innovation and Pipeline Factors

AstraZeneca is investing in next-generation antipsychotics and adjunct therapies, aiming to diversify its psychiatric pipeline. The success of these ventures could indirectly influence the market perception and value of existing formulations like SEROQUEL XR.

Market Trends Shaping the Future

Shift Toward Personalized Psychiatry

Emerging research emphasizes precision medicine, tailoring treatments based on genetic and biomarker profiles. Such trends may limit the future market for broad-spectrum drugs like SEROQUEL XR unless tailored approaches include its use.

Digital Health and Monitoring Technologies

Integration of digital monitoring tools for adherence and symptom tracking may enhance treatment outcomes, favoring longer-acting formulations. This could create niches for sustained-release antipsychotics.

Regulatory Developments

Recent regulatory scrutiny concerning safety profiles, especially regarding metabolic side effects, may influence prescribing behaviors and product positioning.

Conclusion

The financial and market landscape for SEROQUEL XR reflects a classic post-patent trajectory characterized by initial blockbuster revenue followed by decline due to generic competition. Although currently constrained, niche roles and evolving therapeutic strategies can sustain limited revenues. AstraZeneca’s strategic focus on pipeline diversification and innovation remains vital for long-term growth within psychopharmacology.

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Key Takeaways

• Market contraction: SEROQUEL XR’s revenues have diminished significantly after patent expiry, with generics capturing the majority of sales.
• Competitive pressure: The presence of multiple effective oral and long-acting injectables exerts considerable pricing and formulary pressure.
• Niche opportunities: Limited but stable demand persists in specialized settings and specific patient populations, especially where formulation benefits are valued.
• Pipeline importance: Continued investment in innovative therapies is crucial to offset declining legacy product revenues.
• Regulatory and clinical shifts: Evolving safety profiles and personalized medicine trends could challenge or reshape the drug’s market position.

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FAQs

1. What factors contributed to the decline in SEROQUEL XR sales post-2020?
Patent expiration facilitated generic entry, leading to significant price reductions and loss of brand prestige, which together caused sales decline.

2. Can SEROQUEL XR regain market share against newer antipsychotics?
Unlikely in the mainstream; niche applications and formulary preferences might sustain its use, but broader market regain seems improbable without significant innovation.

3. Are there ongoing development efforts to extend SEROQUEL XR’s relevance?
AstraZeneca is focusing on pipeline compounds and combination therapies, but no direct reformulation or new indications for SEROQUEL XR have been publicly announced.

4. How does insurance coverage influence SEROQUEL XR’s market presence?
Formulary placement and copay considerations heavily influence prescribing patterns, especially where generics are preferred for cost reasons.

5. What are the primary clinical advantages of SEROQUEL XR over its competitors?
The extended-release formulation offers improved adherence, once-daily dosing, and a potentially favorable side effect profile in some patients, although these benefits are often shared by newer agents.

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Sources: [1] WHO. Schizophrenia Fact Sheet. 2022.
[2] NIMH. Bipolar Disorder. 2022.
[3] AstraZeneca Annual Report 2021.