Viewing data from:

SEROQUEL XR

NDA

QUETIAPINE FUMARATE | N022047 | CHEPLAPHARM ARZNEIMITTEL GMBH

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ASTRAZENECA PHARMACEUTICALS LP et al v. AMNEAL PHARMACEUTICALS, LLC et al 3:2012cv04841 1 patentANDA 204112quetiapine fumarate	D.N.J.	2012-08-02	Terminated 2013-01-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Seroquel XR (2023)

Total Spending

$9.3M

Total Claims

8,118

Beneficiaries

1,074

Avg Cost/Unit

$20.08

Spending Trend

$18.2M(2019)→$14.8M(2020)→$12.1M(2021)→$10.8M(2022)→$9.3M(2023)

YoY Change:+1.0%

5yr CAGR:+1.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain41 active DMFs15 inactive

35 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDQUETIAPINE FUMARATE USP

DMF 171222004

TAPI NL BVQUETIAPINE FUMARATE

DMF 183412005

MATRIX PHARMACORP PRIVATE LTDQUETIAPINE FUMARATE USP

DMF 188692005

FERMION OYQUETIAPINE FUMARATE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 191602006

APITORIA PHARMA PRIVATE LTDQUETIAPINE FUMARATE

DMF 195162006

OLON SPAQUETIAPINE FUMARATE

DMF 200452006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDQUETIAPINE FUMARATE USP

DMF 207332007

HETERO LABS LTDQUETIAPINE FUMARATE

DMF 208452007

DIVIS LABORATORIES LTDQUETIAPINE FUMARATE

DMF 209832007

IPCA LABORATORIES LTDQUETIAPINE FUMARATE

DMF 210092007

AARTI PHARMALABS LTDQUETIAPINE FUMARATE USP

DMF 213362008

FIS FABBRICA ITALIANA SINTETICI SPAQUETIAPINE FUMARATE

DMF 213582008

LUPIN LTDQUETIAPINE FUMARATE USP

DMF 215132008

TORRENT PHARMACEUTICALS LTDQUETIAPINE FUMARATE

DMF 226712009

UNICHEM LABORATORIES LTDQUETIAPINE FUMARATE USP

DMF 228882009

SUN PHARMACEUTICAL INDUSTRIES LTDQUETIAPINE FUMARATE USP

DMF 232912009

ORBION PHARMACEUTICALS PRIVATE LTDQUETIAPINE FUMARATE (NON STERILE BULK API)

DMF 232922009

ALEMBIC PHARMACEUTICALS LTDQUETIAPINE FUMARATE USP

DMF 233512009

MACLEODS PHARMACEUTICALS LTDQUETIAPINE FUMARATE

DMF 236202010

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDQUETIAPINE FUMARATE

DMF 240362010

HIKAL LTDQUETIAPINE FUMARATE (PROCESS-B) USP

DMF 240872010

MOEHS IBERICA SLQUETIAPINE FUMARATE

DMF 245412011

JUBILANT BIOSYS LTDQUETIAPINE FUMARATE USP

DMF 248002011

PIRAMAL PHARMA LTDQUETIAPINE FUMARATE

DMF 248162011

HETERO LABS LTDQUETIAPINE FUMARATE (PROCESS II)

DMF 257702012

FERMION OYQUETIAPINE FUMARATE "ALTERNATIVE PROCESS"

DMF 259542011

WANBURY LTDQUETIAPINE FUMARATE

DMF 277642013

MEDICHEM SAQUETIAPINE FUMARATE

DMF 288332014

RAKS PHARMA PVT LTDQUETIAPINE FUMARATE USP

DMF 298532015

HETERO LABS LTDQUETIAPINE FUMARATE

DMF 306272016

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)QUETIAPINE FUMARATE

DMF 310742016

COHANCE LIFESCIENCES LTDQUETIAPINE FUMARATE USP

DMF 320852017

VASUDHA PHARMA CHEM LTDQUETIAPINE FUMARATE USP

DMF 328742018

SYNTHIMED LABS PRIVATE LTDQUETIAPINE FUMARATE USP

DMF 331902019

UNICHEM LABORATORIES LTDQUETIAPINE FUMARATE (QPT PROCESS)

DMF 351302020

TAPI NL BVQUETIAPINE FUMARATE

DMF 370412023

IOL CHEMICALS AND PHARMACEUTICALS LTDQUETIAPINE FUMARATE USP

DMF 371052023

CHEMECA DRUGS PRIVATE LTDQUETIAPINE FUMARATE USP

DMF 373152022

APITORIA PHARMA PRIVATE LTDQUETIAPINE FUMARATE USP (PROCESS II)

DMF 378812022

ZHEJIANG SYNCOZYMES BIO-PHARMACEUTICAL CO LTDQUETIAPINE FUMARATE

DMF 400802024

ALKEM LABORATORIES LTDQUETIAPINE FUMARATE USP

DMF 402512024

IND SWIFT LABORATORIES LTDInactiveQUETIAPINE FUMARATE

DMF 187972005

JUBILANT ORGANOSYS LTDInactiveQUETIAPINE FUMARATE

DMF 198362006

UNION QUIMICO FARMACEUTICA SAInactiveQUETIAPINE FUMARATE

DMF 203112007

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveQUETIAPINE FUMARATE

DMF 207062007

FARMAK ASInactiveQUETIAPINE FUMARATE

DMF 208542007

CAMBREX PROFARMACO MILANO SRLInactiveQUETIAPINE FUMARATE

DMF 209812007

CADILA HEALTHCARE LTDInactiveQuetiapine Fumarate

DMF 212072008

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDInactiveQUETIAPINE FUMARATE

DMF 216862008

MENADIONA SLInactiveQUETIAPINE FUMARATE

DMF 218262008

FIS FABBRICA ITALIANA SINTETICI SPAInactiveQUETIAPINE FUMARATE

DMF 244432011

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveQUETIAPINE FUMARATE

DMF 247612011

INDOCO REMEDIES LTDInactiveQUETIAPINE FUMARATE

DMF 250002011

RANBAXY LABORATORIES LTDInactiveQUETIAPINE FUMARATE (NON-STERILE BULK)

DMF 250842011

SYNKEM SASInactiveQUETIAPINE FUMARATE

DMF 259512012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveQUETIAPINE FUMARATE

DMF 266892012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

34 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -48	View Letter (PDF)
Jan 31, 2022	SUPPL -46	View Letter (PDF)
Sep 21, 2020	SUPPL -44	View Letter (PDF)
Sep 21, 2020	SUPPL -41	View Letter (PDF)
May 21, 2020	SUPPL -42	View Letter (PDF)
Feb 6, 2020	SUPPL -43	View Letter (PDF)
Aug 27, 2019	SUPPL -40	View Letter (PDF)
Dec 20, 2018	SUPPL -37	View Letter (PDF)
Dec 20, 2018	SUPPL -33	View Letter (PDF)
Mar 2, 2017	SUPPL -39	View Letter (PDF)
Jun 21, 2016	SUPPL -38	View Letter (PDF)
Oct 30, 2013	SUPPL -34	View Letter (PDF)
May 2, 2013	SUPPL -31	View Letter (PDF)
May 2, 2013	SUPPL -26	View Letter (PDF)
May 2, 2013	SUPPL -29	View Letter (PDF)
May 2, 2013	SUPPL -30	View Letter (PDF)
Nov 14, 2011	SUPPL -28	View Letter (PDF)
Sep 28, 2011	ORIG -1	View Letter (PDF)
Jul 12, 2011	SUPPL -23	View Letter (PDF)
Jul 12, 2011	SUPPL -27	View Letter (PDF)
May 19, 2011	SUPPL -24	View Letter (PDF)
Dec 7, 2010	SUPPL -25	View Letter (PDF)
Dec 30, 2009	SUPPL -22	View Letter (PDF)
Dec 30, 2009	SUPPL -16	View Letter (PDF)
Dec 30, 2009	SUPPL -17	View Letter (PDF)
Dec 30, 2009	SUPPL -19	View Letter (PDF)
Dec 30, 2009	SUPPL -11	View Letter (PDF)
Oct 9, 2008	SUPPL -6	View Letter (PDF)
Oct 9, 2008	SUPPL -8	View Letter (PDF)
Oct 9, 2008	SUPPL -7	View Letter (PDF)
Aug 19, 2008	SUPPL -18	View Letter (PDF)
Aug 13, 2008	SUPPL -13	View Letter (PDF)
May 28, 2008	SUPPL -9	View Letter (PDF)
Mar 17, 2008	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — EQ 50MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: May 17, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 200MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 17, 2007

#003 — EQ 300MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 17, 2007

#004 — EQ 400MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 17, 2007

#005 — EQ 150MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 11, 2008