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Quetiapine fumarate - Generic Drug Details

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Quetiapine fumarate is the generic ingredient in three branded drugs marketed by Alkem Labs Ltd, Lupin Ltd, Roxane, 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, Accord Hlthcare Inc, Aurobindo Pharma Ltd, Alembic Pharms Ltd, and Sun Pharma Global, and is included in twenty-one NDAs. There is one patent protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fifty 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:1
Applicants:20
NDAs:21
Drug Master File Entries: see list50
Suppliers / Packaging: see list52
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: quetiapine fumarate

Tentative approvals for QUETIAPINE FUMARATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL50MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL150MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL077745-004Mar 27, 2012RXNo► subscribe► subscribe
Roxane
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL090749-001Mar 27, 2012RXNo► subscribe► subscribe
Apotex Inc
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL090960-006Mar 27, 2012RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: quetiapine fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-004May 17, 20074,879,288*PED► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-001Sep 26, 19974,879,288*PED► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-005Jul 26, 20004,879,288*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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