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Last Updated: October 16, 2019

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Quetiapine fumarate - Generic Drug Details

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What are the generic sources for quetiapine fumarate and what is the scope of patent protection?

Quetiapine fumarate is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Anchen Pharms, Aurobindo Pharma Ltd, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, Pharmadax Inc, Sciegen Pharms Inc, Astrazeneca, Actavis Grp Ptc, Alembic Pharms Ltd, Alkem Labs Ltd, Apotex Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, Unichem Labs Ltd, West-ward Pharms Int, and Astrazeneca Pharms, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty-three drug master file entries for quetiapine fumarate. Fifty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for quetiapine fumarate

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Drug Sales Revenue Trends for quetiapine fumarate

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Recent Clinical Trials for quetiapine fumarate

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
VA Connecticut Healthcare SystemPhase 4
Ewha Womans UniversityPhase 2

See all quetiapine fumarate clinical trials

Recent Litigation for quetiapine fumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca Pharmaceuticals LP v. Pharmadax USA, Inc.2014-10-23
ASTRAZENECA PHARMACEUTICALS LP v. LUPIN LTD2012-11-05
ASTRAZENECA PHARMACEUTICALS LP v. AMNEAL PHARMACEUTICALS, LLC2012-08-02

See all quetiapine fumarate litigation

Generic filers with tentative approvals for QUETIAPINE FUMARATE
Applicant Application No. Strength Dosage Form
  See Pricing  See Pricing400MGTABLET, EXTENDED RELEASE; ORAL
  See Pricing  See Pricing300MGTABLET, EXTENDED RELEASE; ORAL
  See Pricing  See Pricing200MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for quetiapine fumarate
Medical Subject Heading (MeSH) Categories for quetiapine fumarate
Synonyms for quetiapine fumarate
(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
111974-72-2
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)thiazepin-11-yl-1-piperazinyl)ethoxy)ethanol fumarate (2:1) (salt)
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-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),3,5,7,9,12,14-heptaen-10-yl}piperazin-1-yl)ethoxy]ethanol; fumaric acid; quetiapine
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][1,4]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol; (E)-but-2-enedioic acid
2-[2-(4-benzo[b][1,4]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol;(E)-but-2-enedioic acid
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 fumarate (2:1) (salt)
2-[2-(4-Dibenzo[b, f][1,4]thiazepin-11-ylpiperazin-1-yl)ethoxy]ethanol hemifumarate
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]ethanol hemifumarate
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
2C21H25N3O2S.C4H4O4
2S3PL1B6UJ
4769-EP2272537A2
4769-EP2272841A1
4769-EP2275420A1
4769-EP2298731A1
4769-EP2301936A1
4769-EP2308867A2
4769-EP2308870A2
74Q697
974Q697
AB00640033_11
AB00640033_12
AB00640033-09
AB00640033-10
AC-4236
AC1L1JE6
AC1NQXWT
AKOS003588973
AKOS015855887
AN-12155
AN-16952
API0004010
AS-12050
AS-35258
BBL029071
BC219347
BCP04154
BCP23508
BDBM50095890
BGL0JSY5SI
BIDD:GT0279
bis(2-(2-(4-(dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethan-1-ol) fumarate
BRD-K68867920-001-05-2
C07397
C21H25N3O2S
CAS-111974-69-7
CAS-111974-72-2
CCG-213347
CCG-220464
CHEBI:8707
CHEBI:8708
CHEMBL3188993
CHEMBL716
Co-Quetiapine
CS-1171
CTK8F1296
D00458
D08456
DB01224
DSSTox_CID_24201
DSSTox_CID_3546
DSSTox_GSID_23546
DSSTox_GSID_44201
DSSTox_RID_77073
DSSTox_RID_80114
DTXSID3044201
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)-, (E)-2-butenedioate (2:1) (salt)
Ethanol, 2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-
FK949E
FT-0658790
fumaric acid; bis(quetiapine)
GTPL50
HMS2089G04
HMS2093K06
HMS2231O11
HMS3372B05
HMS3713M10
HSDB 7557
HY-14544
I06-1980
I14-0768
ICI 204,636
ICI 204636
ICI-204636
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
J-002679
K-0936
KB-60267
KB-80284
KS-1099
L001200
LS-172170
LS-66641
M872
MFCD03423782
MLS001165710
MLS001195658
MolPort-002-506-329
MolPort-006-069-133
MRF-0000010
NCGC00095911-01
NCGC00095911-03
NCGC00095911-04
NCGC00095911-06
NCGC00255945-01
Norsic (TN)
NSC-758918
NSC758918
Pharmakon1600-01505187
Q-201653
quetiapina
quetiapine
Quetiapine (INN)
Quetiapine [INN:BAN]
Quetiapine for system suitability, European Pharmacopoeia (EP) Reference Standard
Quetiapine fumarate (JP17/USAN)
Quetiapine fumarate (Seroquel)
Quetiapine fumarate [USAN]
Quetiapine Fumarate 1.0 mg/ml in Methanol (as free base)
Quetiapine fumarate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Quetiapine fumarate, European Pharmacopoeia (EP) Reference Standard
Quetiapine Fumarate, Pharmaceutical Secondary Standard; Certified Reference Material
Quetiapine fumarate, United States Pharmacopeia (USP) Reference Standard, monograph mol wt. 883.09 ((C21H25N3O2S)2 ?? C4H4O4)
Quetiapine hemifumarate
Quetiapine hemifumarate salt, >=98% (HPLC)
quetiapinum
RT-015180
RTC-070917
SBI-0206776.P001
SC-19077
SCHEMBL122596
SCHEMBL390694
SCHEMBL7932
Seroquel
Seroquel (Fumarate)
Seroquel (TN)
Seroquel XR
SMR000550491
SPECTRUM1505187
SR-01000759335
SR-01000759335-5
SR-01000759335-7
STL373578
SW220283-1
TC-070917
Tox21_111537
Tox21_111537_1
Tox21_302366
UNII-2S3PL1B6UJ
UNII-BGL0JSY5SI
URKOMYMAXPYINW-UHFFFAOYSA-
URKOMYMAXPYINW-UHFFFAOYSA-N
W-5151
ZD 5077
ZD5077
ZINC19632628
ZLA0014
zlchem 12
ZM 204,636
ZM 204636
ZM-204636
ZTHJULTYCAQOIJ-WXXKFALUSA-N

US Patents and Regulatory Information for quetiapine fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Grp Ptc QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201762-001 Feb 27, 2013 DISCN No No   See Pricing   See Pricing   See Pricing
Sun Pharm QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201190-001 Mar 27, 2012 AB RX No No   See Pricing   See Pricing   See Pricing
Alembic Pharms Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 203390-001 Oct 28, 2014 AB RX No No   See Pricing   See Pricing   See Pricing
Aurobindo Pharma Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 091388-003 Mar 27, 2012 AB RX No No   See Pricing   See Pricing   See Pricing
Sandoz QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 078679-005 Dec 14, 2012 AB RX No No   See Pricing   See Pricing   See Pricing
>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 quetiapine fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-002 May 17, 2007   See Pricing   See Pricing
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-006 Oct 4, 2005   See Pricing   See Pricing
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-003 Sep 26, 1997   See Pricing   See Pricing
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-002 Sep 26, 1997   See Pricing   See Pricing
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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