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Last Updated: August 1, 2021

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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 freedom to operate?

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, Mylan, 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, and Zennova, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty-three drug master file entries for quetiapine fumarate. Forty-eight 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
Alkem Labs Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504-003 Feb 12, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Macleods Pharms Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 204253-001 Nov 29, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 207655-001 Nov 29, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alkem Labs Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504-005 Feb 12, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Grp Ptc QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201762-001 Feb 27, 2013 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-002 May 17, 2007 ⤷  Try it Free ⤷  Try it Free
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-002 Sep 26, 1997 ⤷  Try it Free ⤷  Try it Free
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997 ⤷  Try it Free ⤷  Try it Free
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007 ⤷  Try it Free ⤷  Try it Free
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-004 Dec 20, 1998 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Express Scripts
Moodys

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