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Last Updated: March 8, 2021

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Quetiapine fumarate - Generic Drug Details

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What are the generic drug 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, Dr Reddys Labs Ltd, Hikma, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, Unichem, Zennova, 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. Forty-seven suppliers are listed 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
The University of Texas Health Science Center at San AntonioEarly Phase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2
VA Connecticut Healthcare SystemPhase 4

See all quetiapine fumarate clinical trials

Pharmacology for quetiapine fumarate
Medical Subject Heading (MeSH) Categories for quetiapine fumarate
Paragraph IV (Patent) Challenges for QUETIAPINE FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-11-17
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-10-17
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-06-18
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-06-12
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2007-02-12
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2006-02-21
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2005-08-12

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
Par Pharm QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 090482-002 May 9, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Novast Labs QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 208947-002 Nov 29, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Zennova QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 090960-004 Mar 27, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 204253-002 Nov 29, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Anchen Pharms QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 090757-003 Dec 1, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Alignscience Pharma QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 209497-001 Sep 28, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
>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 Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-003 Sep 26, 1997   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-007 Oct 4, 2005   Start Trial   Start Trial
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-004 May 17, 2007   Start Trial   Start Trial
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007   Start Trial   Start Trial
Astrazeneca Pharms SEROQUEL quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997   Start Trial   Start Trial
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-002 May 17, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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