SEROQUEL Drug Patent Profile

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

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. Forty-eight 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:	5,182
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

Expired US Patents for SEROQUEL

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

International Patents for SEROQUEL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	980022
Zambia	2987	THIAZEPINE COMPOUNDS
Hong Kong	85393	THIAZEPINE COMPOUNDS
Norway	871267

Supplementary Protection Certificates for SEROQUEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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