SEROQUEL Drug Patent Profile

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

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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	192
Patent Applications:	4,657
Drug Prices:	Drug price information 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
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
Cheplapharm	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	AB	RX	Yes	No
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-007	Oct 4, 2005	AB	RX	Yes	No
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-002	Sep 26, 1997	AB	RX	Yes	No

Expired US Patents for SEROQUEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-003	Sep 26, 1997
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-001	Sep 26, 1997
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-006	Oct 4, 2005
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-005	Jul 26, 2000
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-004	Dec 20, 1998
Cheplapharm	SEROQUEL	quetiapine fumarate	TABLET;ORAL	020639-002	Sep 26, 1997
Cheplapharm	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
Mexico	9202951	NUEVA DIBENZOTIAZEPINA ANTIPSICOTICA.
Finland	86059
Finland	871137
South Africa	8701940
Germany	10075017
Luxembourg	90593
New Zealand	219788	11-(4-(2-(2-HYDROXYETHOXY) ETHYL)-1-PIPERAZINYL)-DIBENZO (B,F)(1,4) THIAZEPINE; AND PREPARATIONS

Supplementary Protection Certificates for SEROQUEL

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
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

Market Dynamics and Financial Trajectory for SEROQUEL (Quetiapine)

Last updated: December 17, 2025

Summary

SEROQUEL (quetiapine), a second-generation antipsychotic developed by AstraZeneca, has become a cornerstone for treating schizophrenia, bipolar disorder, and adjunctive depression. The drug's market trajectory is influenced by evolving regulatory policies, patent expirations, competition, and emerging therapeutics. The global market for quetiapine illustrates substantial growth, with projected revenue peaks and strategic shifts driven by patent cliffs, generics, and newer formulations. This report provides a comprehensive analysis of SEROQUEL's current market landscape, financial outlook, competitive positioning, and future potential.

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What Are the Key Market Drivers for SEROQUEL?

1. Therapeutic Scope and Clinical Adoption

• Approved Indications: Schizophrenia, bipolar disorder (mania and depression), augmentation in major depressive disorder.
• Off-label Use: Insomnia, anxiety—though off-label uses pose regulatory and safety challenges.
• Clinical Guidelines: Endorsements by APA and NICE support widespread prescribing.

2. Patent and Regulatory Timeline

Milestone	Date	Impact
Original patent filing	1992	Market exclusivity secured
Patent expiration (US, EU)	2014–2016	Entry of generic versions
New formulations (XR, disintegrating)	2017–2019	Extended market reach, reduced competition on formulations

3. Market Penetration and Prescription Trends

• Global Market Growth: Estimated CAGR of 4.5% from 2021 to 2027 [1].
• Prescription Volume: US prescriptions exceeded 50 million units in 2022, with steady growth.

4. Competitive Landscape

Competitor	Key Drugs	Market Share (2022)	Notes
Risperdal (Risperidone)	Risperidone	23%	First-generation rival with similar indications
Abilify (Aripiprazole)	Aripiprazole	19%	Growing due to favorable side effect profile
Lurasidone (Latuda)	Lurasidone	8%	Niche but expanding market segment
Generic Quetiapine	Quetiapine	50% of prescriptions	Price competition drives volume

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What Are the Financial Trajectories and Revenue Dynamics?

1. Revenue Trends Pre- and Post-Patent Expiry

Year	Global SEROQUEL Revenue (USD millions)	Notes
2013	$4,384	Peak prior to patent expiry
2017	$800	Post-patent phase, generic competition intensifies
2020	$950	Slight recovery due to new formulations
2022	$1,150	Growth driven by expansion into emerging markets

Sources: AstraZeneca Annual Reports [2].

2. Impact of Patent Expiry and Generics

• Patent Expiration (~2014-2016): Led to a significant revenue decline (~81% drop from peak).
• Generics’ Market Entry: Price erosion peaked at 70-80%, but volume offsets reduced profitability.

3. Emerging Revenue Streams

• Extended-Release (XR) and Disintegrating Formulations: Launched 2017–2019, representing approximately 30% of total sales by 2022.
• Market Expansion: Key growth areas include China, India, Latin America; total market enlarges at ~10–12% annually [3].

4. Forecasted Revenue (2023–2030)

Year	Estimated Revenue (USD millions)	Assumptions
2023	$1,300–$1,500	Growth in emerging markets, reformulation sales
2025	$1,600–$1,800	Return of pricing power, patent protections for some formulations
2030	$2,500–$3,000	Market maturation, potential biosimilar competition

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How Do Patent Expirations and Biosimilar Entry Shape Competition?

Patent Landscape & Biosimilar Development

• Current Status:

  • US patent protection ended in 2014; EU expired in 2016.
  • No biosimilar versions of quetiapine approved yet, as it’s not a biologic; but generics dominate.

• Impact:

  • Generics flooded markets post-expiry, reducing prices.
  • AstraZeneca's revenue shifted focus from proprietary sales to partnerships and ancillary services.

Market Share Shifts (Post-Patent)

Year	Brand vs. Generic Prescriptions	Brand Market Share	Generic Market Share
2014	80% Brand	80%	20%
2018	50% Brand	50%	50%
2022	20% Brand	20%	80%

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What Future Opportunities and Challenges Are on the Horizon?

Opportunities

• New Formulations and Delivery Systems: Long-acting injectables, better side effect profile formulations.
• Expanding Indications: Adjunctive uses for treatment-resistant depression and adjunct autism spectrum disorder.
• Market Penetration: Targeting emerging markets with rising mental health awareness.

Challenges

• Generic Competition: Continued price erosion threatens profit margins.
• Regulatory Hurdles: Stringent safety and efficacy evaluations may delay new formulations.
• Therapeutic Competition: Growth of novel therapeutics (e.g., SAMe, orexin antagonists) for sleep and mood disorders.
• Safety Concerns: Metabolic side effects and weight gain continue to impact prescribing patterns.

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How Does SEROQUEL Compare to Other Antipsychotics in Market Dynamics?

Parameter	SEROQUEL	Risperdal	Abilify	Lurasidone
Patent Status	Expired (2016)	Expired (2015)	Patent Expired (2017)	Still under patent
Prescription Volume (2022)	High	High	Growing	Niche but expanding
Main Indications	Schizophrenia, bipolar, adjunct	Schizophrenia, bipolar	Schizophrenia, bipolar	Schizophrenia, depression

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Summary of Financial Outlook and Market Dynamics

Aspect	Status / Outlook
Revenue Peak	$4.4 billion in 2013
Post-Patent Revenue Decline	Down to under $1 billion in 2017
Recovery Drivers	New formulations (XR, disintegrating tablets), emerging markets
Future Revenue Potential	$2.5–$3.0 billion by 2030
Major Market Challenges	Generic erosion, safety concerns, competition from newer agents
Strategic Opportunities	Expanded indications, better formulations, geographic expansion

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Key Takeaways

• Market evolution post-patent expiration: Revenue declined sharply after 2016 but stabilized with new formulations and geographic expansion.
• Diversification remains critical: SEROQUEL’s future hinges on innovations like long-acting injectables and expanded indications.
• Competitive landscape is intensifying: Generics dominate, though brand positioning on safety and unique formulations still influence market share.
• Emerging markets offer growth: Countries with rising mental health awareness present substantial opportunities.
• Regulatory and safety considerations: Ongoing safety concerns around metabolic side effects could influence prescribing patterns and market penetration.

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FAQs

1. How has patent expiry affected SEROQUEL’s market share and revenue?
Patent expiry in 2014–2016 led to a sharp decline in revenue (~81%), with prices of generic versions driving volume but reducing profitability for AstraZeneca.

2. What are the primary drivers for SEROQUEL's future growth?
Growth prospects depend on new formulations, expanding indications, market expansion into emerging regions, and potentially novel delivery methods.

3. What is the competitive outlook for branded vs. generic quetiapine?
Generics hold the majority share (~80%), pressuring branded sales; however, branded formulations with improved safety profiles or unique delivery systems can sustain premium pricing.

4. How do safety issues influence SEROQUEL’s market dynamics?
Concerns over metabolic side effects limit prescribing in some populations, but better safety profiles and monitoring protocols can mitigate this impact.

5. Are biosimilars or biologics relevant to SEROQUEL’s future trajectory?
No, as quetiapine is a small-molecule drug, biosimilars are not applicable. The focus remains on generics and reformulation innovations.

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References

[1] IQVIA. (2022). Global Psychiatric Market Overview.
[2] AstraZeneca Annual Reports. (2013–2022).
[3] GlobalData. (2022). Emerging Markets Forecast for Antipsychotics.