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Generated: April 28, 2017

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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 Alkem Labs Ltd, Lupin Ltd, West-ward Pharms Int, Mylan Pharms Inc, Astrazeneca Pharms, Teva Pharms, Astrazeneca, Jubilant Generics, Accord Hlthcare, Macleods Pharms Ltd, Apotex Inc, Actavis Grp Ptc, Torrent Pharms Ltd, Unichem Labs Ltd, Sandoz, Dr Reddys Labs Ltd, Aurobindo Pharma Ltd, Alembic Pharms Ltd, and Sun Pharma Global, and is included in twenty-one NDAs. There are two patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: quetiapine fumarate

Tradenames:3
Patents:2
Applicants:19
NDAs:21
Drug Master File Entries: see list51
Suppliers / Packagers: see list52
Bulk Api Vendors: see list107
Clinical Trials: see list349
Patent Applications: see list4,533
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:quetiapine fumarate at DailyMed

Pharmacology for Ingredient: quetiapine fumarate

Tentative approvals for QUETIAPINE FUMARATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL50MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL150MG
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORAL200MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL201109-005Mar 27, 2012ABRXNoNo► Subscribe► Subscribe
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-003May 17, 2007RXYesNo5,948,437*PED► SubscribeY► Subscribe
Accord Hlthcare
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL202152-002Mar 27, 2012ABRXNoNo► Subscribe► Subscribe
Actavis Grp Ptc
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL201762-002Feb 27, 2013DISCNNoNo► Subscribe► Subscribe
Apotex Inc
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL090960-006Mar 27, 2012ABRXNoNo► Subscribe► Subscribe
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