SEROQUEL XR Drug Patent Profile

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

Seroquel Xr is a drug marketed by Astrazeneca 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:	1
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	192
Patent Applications:	2,078
Drug Prices:	Drug price information for SEROQUEL XR
Drug Sales Revenues:	Drug sales revenues 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
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	AB	RX	Yes	No
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-003	May 17, 2007	AB	RX	Yes	No
Astrazeneca	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
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	5,948,437*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

International Patents for SEROQUEL XR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0240228	THIAZEPINE COMPOUNDS
Denmark	174618
Australia	7045987

Supplementary Protection Certificates for SEROQUEL XR

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	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	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

SEROQUEL XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Seroquel XR

Introduction to Seroquel XR

Seroquel XR, an extended-release formulation of quetiapine fumarate, is an atypical antipsychotic medication used primarily for the treatment of schizophrenia, bipolar disorder, and in some markets, major depressive disorder and generalized anxiety disorder[1][2][4].

Market Context

The global antipsychotic drugs market is significant and growing, valued at USD 16.88 billion in 2023 and projected to grow at a CAGR of 6.1% from 2024 to 2030. The second-generation antipsychotics, which include Seroquel XR, dominate this market with a 62.9% revenue share in 2023, driven by their enhanced efficiency and safety[5].

Patent and Market Exclusivity

Seroquel and Seroquel XR have lost their compound patent protection globally, and the formulation patents for Seroquel XR have also expired in most markets. This loss of patent protection has led to a strategic shift in how AstraZeneca manages these products[1][2][3].

Divestment Strategy

AstraZeneca has adopted a strategy to divest the commercial rights to Seroquel and Seroquel XR in various markets to focus on its core therapy areas: Oncology, Cardiovascular, Renal & Metabolism, and Respiratory.

US and Canada

In 2019, AstraZeneca divested the commercial rights to Seroquel and Seroquel XR in the US and Canada to Cheplapharm Arzneimittel GmbH. This deal included an upfront payment of $35 million and potential future sales-contingent payments of up to $6 million. In 2018, Seroquel generated $36 million in sales, while Seroquel XR generated $79 million in these markets[1].

Europe and Russia

AstraZeneca also completed an agreement with Cheplapharm to divest the commercial rights in Europe (excluding the UK) and Russia. This transaction involved an upfront payment of $178 million and potential future sales-contingent payments of up to $61 million. The aggregate profit before tax for Seroquel and Seroquel XR in these territories was $86 million in 2018[2].

UK, China, and Other International Markets

In 2018, AstraZeneca entered into an agreement with Luye Pharma Group to divest the rights to Seroquel and Seroquel XR in the UK, China, and other international markets. Luye Pharma paid $538 million, including $260 million immediately, with additional milestone payments. In 2017, Seroquel generated $85 million in sales, and Seroquel XR generated $63 million in these markets[3].

Financial Impact

The divestments have provided AstraZeneca with significant upfront payments and potential future revenues. Here are some key financial figures:

• US and Canada: $35 million upfront payment, with up to $6 million in future sales-contingent payments. Aggregate profit before tax in 2018 was $108 million[1].
• Europe and Russia: $178 million upfront payment, with up to $61 million in future sales-contingent payments. Aggregate profit before tax in 2018 was $86 million[2].
• UK, China, and Other International Markets: $538 million total consideration, including $260 million upfront. Aggregate sales in 2017 were $85 million for Seroquel and $63 million for Seroquel XR[3].

Continued Patient Access

Despite the divestments, AstraZeneca continues to manufacture and supply Seroquel and Seroquel XR to the new rights holders during transition periods, ensuring continued patient access to these medications[1][2][3].

Market Performance

The sales performance of Seroquel and Seroquel XR has been significant, even after the loss of patent protection. Here are some key sales figures:

• 2018 (US and Canada): Seroquel generated $36 million, while Seroquel XR generated $79 million[1].
• 2018 (Europe and Russia): Aggregate profit before tax was $86 million[2].
• 2017 (UK, China, and Other International Markets): Seroquel generated $85 million, and Seroquel XR generated $63 million[3].

Future Outlook

The divestment strategy allows AstraZeneca to reinvest in its core therapy areas while ensuring that Seroquel and Seroquel XR continue to be available to patients through new commercial partners. The global antipsychotic market's growth, driven by the demand for second-generation antipsychotics, suggests that Seroquel XR will remain a relevant treatment option in the coming years[5].

"The agreement with Luye Pharma is in line with AstraZeneca’s strategy to focus on three main therapy areas while maximising the value from our legacy medicines like Seroquel," - Mark Mallon, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca[3].

Key Takeaways

• Seroquel XR is a second-generation antipsychotic with significant market presence despite losing patent protection.
• AstraZeneca has divested commercial rights to Seroquel and Seroquel XR in various markets to focus on core therapy areas.
• Divestments have generated substantial upfront and potential future payments.
• Continued patient access is ensured through manufacturing and supply agreements.
• The global antipsychotic market is growing, with second-generation antipsychotics like Seroquel XR driving this growth.

FAQs

Q: What are the primary indications for Seroquel XR? A: Seroquel XR is primarily indicated for the treatment of schizophrenia, bipolar disorder, and in some markets, major depressive disorder and generalized anxiety disorder[4].

Q: Why did AstraZeneca divest the rights to Seroquel and Seroquel XR? A: AstraZeneca divested the rights to focus on its core therapy areas of Oncology, Cardiovascular, Renal & Metabolism, and Respiratory, while maximizing the value from its legacy medicines[1][2][3].

Q: Who are the new commercial rights holders for Seroquel and Seroquel XR in different markets? A: Cheplapharm Arzneimittel GmbH holds the rights in the US, Canada, Europe (excluding the UK), and Russia, while Luye Pharma Group holds the rights in the UK, China, and other international markets[1][2][3].

Q: What were the financial considerations for the divestments? A: The divestments involved significant upfront payments and potential future sales-contingent payments, with total considerations ranging from $35 million to $538 million depending on the market[1][2][3].

Q: How does the loss of patent protection affect the market dynamics of Seroquel XR? A: Despite the loss of patent protection, Seroquel XR remains a relevant treatment option due to its inclusion in the second-generation antipsychotic class, which dominates the market[5].

Sources

1. AstraZeneca Press Release: "AstraZeneca divests rights to Seroquel and Seroquel XR in the US and Canada"[1].
2. AstraZeneca Press Release: "Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia completed"[2].
3. 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"[3].
4. FDA Label: "SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets"[4].
5. Grand View Research: "Antipsychotic Drugs Market Size And Share Report, 2030"[5].