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Last Updated: March 19, 2024

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, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, 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, Jubilant Generics, Mylan Pharms Inc, Sandoz, Sun Pharm, Teva Pharms, Torrent Pharms Ltd, and Zennova, and is included in thirty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-eight 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
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
Unichem QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 215478-002 Aug 15, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 201504-005 Feb 12, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 204316-004 Jun 16, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-003 May 17, 2007 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-005 Jul 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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