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Last Updated: December 16, 2019

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SEROQUEL Drug Profile

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Which patents cover Seroquel, and when can generic versions of Seroquel launch?

Seroquel is a drug marketed by Astrazeneca Pharms and 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-nine suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Seroquel

A generic version of SEROQUEL was launched as quetiapine fumarate by ACCORD HLTHCARE on December 16th, 2019.

Drug patent expirations by year for SEROQUEL
Drug Prices for SEROQUEL

See drug prices for SEROQUEL

Drug Sales Revenue Trends for SEROQUEL

See drug sales revenues for SEROQUEL

Recent Clinical Trials for SEROQUEL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PRA Health SciencesPhase 1
Otsuka Pharmaceutical Development & Commercialization, Inc.Phase 1
Astellas Pharma Global Development, Inc.Phase 2

See all SEROQUEL clinical trials

Recent Litigation for SEROQUEL

Identify potential future generic entrants

District Court Litigation
Case NameDate
ASTRAZENECA PHARMACEUTICALS LP v. ANCHEN PHARMACEUTICALS, INC.2010-04-08
ASTRAZENECA PHARMACEUTICALS LP v. TEVA PHARMACEUTICALS USA, INC.

See all SEROQUEL litigation

Pharmacology for SEROQUEL
Synonyms for SEROQUEL
(E)-2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol
11-[4-[2-(2-Hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f][1,4]thiazepine
111974-69-7
2-(2-(4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethan-1-ol
2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol
2-(2-(4-Dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)ethanol
2-(2-(4-dibenzo[b,f]-[1,4]thiazepine-11-yl-1-piperazinyl)ethoxy)ethanol
2-(2-(4-dibenzo[b,f][1,4] thiazepine-11-yl-1-piperazinyl)ethoxy)ethanol
2-[2-(4-{2-thia-9-azatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaen-10-yl}piperazin-1-yl)ethoxy]ethan-1-ol
2-[2-(4-benzo[b][1,4]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol
2-[2-(4-benzo[b][1,5]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol
2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol
2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-ylpiperazin-1-yl)ethoxy]ethanol
2-{[2-(4-dibenzo[b,f][1,4]thiazepin-11-ylpiperazin-1-yl)ethyl]oxy}ethanol
2-{2-[4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethoxy}ethanol
4769-EP2272537A2
4769-EP2272841A1
4769-EP2275420A1
4769-EP2298731A1
4769-EP2301936A1
4769-EP2308867A2
4769-EP2308870A2
74Q697
AB00640033_11
AB00640033_12
AB00640033-09
AB00640033-10
AC1L1JE6
AKOS003588973
AN-12155
AN-16952
API0004010
AS-35258
BBL029071
BC219347
BCP23508
BDBM50095890
BGL0JSY5SI
BIDD:GT0279
BRD-K68867920-001-05-2
C07397
C21H25N3O2S
CAS-111974-69-7
CCG-213347
CHEBI:8707
CHEMBL716
Co-Quetiapine
CS-1171
CTK8F1296
D08456
DB01224
DSSTox_CID_3546
DSSTox_GSID_23546
DSSTox_RID_77073
DTXSID9023546
ETH065
Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)-
Ethanol, 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-
FK949E
FT-0658790
GTPL50
HMS2093K06
HMS2231O11
HMS3372B05
HSDB 7557
HY-14544
I06-1980
InChI=1/C21H25N3O2S/c25-14-16-26-15-13-23-9-11-24(12-10-23)21-17-5-1-3-7-19(17)27-20-8-4-2-6-18(20)22-21/h1-8,25H,9-16H2
KB-80284
L001200
LS-172170
M872
MLS001165710
MLS001195658
MolPort-002-506-329
MRF-0000010
NCGC00095911-01
NCGC00095911-03
NCGC00095911-04
NCGC00095911-06
Norsic (TN)
NSC-758918
NSC758918
Pharmakon1600-01505187
quetiapina
quetiapine
Quetiapine (INN)
Quetiapine [INN:BAN]
Quetiapine fumarate
quetiapinum
RT-015180
SBI-0206776.P001
SC-19077
SCHEMBL7932
Seroquel (Fumarate)
SMR000550491
SPECTRUM1505187
SR-01000759335
SR-01000759335-5
SR-01000759335-7
STL373578
Tox21_111537
Tox21_111537_1
UNII-BGL0JSY5SI
URKOMYMAXPYINW-UHFFFAOYSA-
URKOMYMAXPYINW-UHFFFAOYSA-N
W-5151
ZINC19632628
ZM-204636
Paragraph IV (Patent) Challenges for SEROQUEL
Tradename Dosage Ingredient NDA Submissiondate
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2007-02-12
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2006-02-21
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 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 Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-006 Oct 4, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-004 Dec 20, 1998 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-004 May 17, 2007 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-007 Oct 4, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
>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 Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-003 Sep 26, 1997   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-006 Oct 4, 2005   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-005 Jul 26, 2000   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-004 Dec 20, 1998   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-002 Sep 26, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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