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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Federal Trade Commission
Novartis
Chubb
Fish and Richardson
Daiichi Sankyo
McKesson
Chinese Patent Office
Johnson and Johnson

Generated: June 22, 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 quetiapine fumarate patent protection?

Quetiapine fumarate
is the generic ingredient in three branded drugs marketed by Lupin Ltd, Alkem Labs Ltd, West-ward Pharms Int, Mylan Pharms Inc, Intellipharmaceutics, Astrazeneca Pharms, Teva Pharms, Astrazeneca, Jubilant Generics, Accord Hlthcare, Macleods Pharms Ltd, Pharmadax Inc, Apotex Inc, Actavis Grp Ptc, Torrent Pharms Ltd, Unichem Labs Ltd, Sandoz, Dr Reddys Labs Ltd, Par Pharm, Aurobindo Pharma Ltd, Alembic Pharms Ltd, and Sun Pharma Global, and is included in twenty-five 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-four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: quetiapine fumarate

Tradenames:3
Patents:2
Applicants:22
NDAs:25
Drug Master File Entries: see list51
Suppliers / Packagers: see list54
Bulk Api Vendors: see list107
Clinical Trials: see list782
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. Strength Dosage Form
► Subscribe► Subscribe50MGTABLET, EXTENDED RELEASE; ORAL
► Subscribe► Subscribe400MGTABLET, EXTENDED RELEASE; ORAL
► Subscribe► Subscribe300MGTABLET, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intellipharmaceutics
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL202939-002May 9, 2017ABRXNoNo► Subscribe► Subscribe
Accord Hlthcare
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL090681-004Nov 1, 2016ABRXNoNo► Subscribe► Subscribe
Alkem Labs Ltd
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET;ORAL201504-005Feb 12, 2013ABRXNoNo► Subscribe► Subscribe
Accord Hlthcare
QUETIAPINE FUMARATE
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL090681-003May 9, 2017ABRXNoNo► Subscribe► Subscribe
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-005Aug 11, 2008ABRXYesNo5,948,437*PED► SubscribeY► 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 Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-004Dec 20, 19984,879,288*PED► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-005Jul 26, 20004,879,288*PED► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-006Oct 4, 20054,879,288*PED► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-001Sep 26, 19974,879,288*PED► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-003Sep 26, 19974,879,288*PED► Subscribe
This preview shows a limited data set
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Export unavailable in trial.
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Healthtrust
Harvard Business School
Merck
AstraZeneca
Cantor Fitzgerald
Dow
Citi
Accenture
UBS
McKinsey

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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