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Last Updated: November 2, 2024

SEROQUEL Drug Patent Profile


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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 27th, 2012.

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Drug patent expirations by year for SEROQUEL
Drug Prices for SEROQUEL

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Drug Sales Revenue Trends for SEROQUEL

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Recent Clinical Trials for SEROQUEL

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SponsorPhase
Ain Shams UniversityN/A
University of MiamiPhase 4
Alzheimer's AssociationPhase 4

See all SEROQUEL clinical trials

Pharmacology for SEROQUEL
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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-006 Oct 4, 2005 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-004 Dec 20, 1998 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-004 May 17, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-007 Oct 4, 2005 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-002 Sep 26, 1997 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-002 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-005 Jul 26, 2000 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-007 Oct 4, 2005 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-006 Oct 4, 2005 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-003 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SEROQUEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0240228 SPC/GB97/086 United Kingdom ⤷  Sign Up 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 C980022 Netherlands ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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