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Last Updated: November 2, 2024

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 Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Endo Operations, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Astrazeneca, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Norvium Bioscience, Sandoz, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-eight 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
Alphacait, LLCPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all QUETIAPINE FUMARATE clinical trials

Pharmacology for QUETIAPINE FUMARATE
Medical Subject Heading (MeSH) Categories for QUETIAPINE FUMARATE
Anatomical Therapeutic Chemical (ATC) Classes for QUETIAPINE FUMARATE
Paragraph IV (Patent) Challenges for QUETIAPINE FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SEROQUEL XR Extended-release Tablets quetiapine fumarate 150 mg 022047 1 2008-11-17
SEROQUEL XR Extended-release Tablets quetiapine fumarate 50 mg 022047 1 2008-10-17
SEROQUEL XR Extended-release Tablets quetiapine fumarate 400 mg 022047 1 2008-06-18
SEROQUEL XR Extended-release Tablets quetiapine fumarate 200 mg and 300 mg 022047 1 2008-06-12
SEROQUEL Tablets quetiapine fumarate 50 mg, 150 mg and 400 mg 020639 1 2007-02-12
SEROQUEL Tablets quetiapine fumarate 100 mg, 200 mg and 300 mg 020639 1 2006-02-21
SEROQUEL Tablets quetiapine fumarate 25 mg 020639 1 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
Torrent Pharms Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 200363-004 Mar 27, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 077745-005 Mar 27, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 022047-005 Aug 11, 2008 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-007 Oct 4, 2005 ⤷  Sign Up ⤷  Sign Up
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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