Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
McKesson
Dow
Boehringer Ingelheim
AstraZeneca

Last Updated: December 5, 2022

Quetiapine fumarate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Intellipharmaceutics, Lupin Ltd, Macleods Pharms Ltd, Novast Labs, Par Pharm, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms Inc, Unichem, Astrazeneca, Actavis Grp Ptc, Alembic Pharms Ltd, 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-eight suppliers are listed for this compound.

Drug Prices for quetiapine fumarate

See drug prices for quetiapine fumarate

Drug Sales Revenue Trends for quetiapine fumarate

See drug sales revenues for quetiapine fumarate

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
Alphacait, LLCPhase 2

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 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
Rising QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 202228-005 Feb 2, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novast Labs QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 208947-004 Nov 29, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 091388-006 Mar 27, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmadax Inc QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 206260-001 May 9, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 203390-001 Oct 28, 2014 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sandoz QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 078679-002 Dec 14, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma QUETIAPINE FUMARATE quetiapine fumarate TABLET;ORAL 090749-005 Mar 27, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 quetiapine fumarate TABLET;ORAL 020639-001 Sep 26, 1997 See Plans and Pricing See Plans and Pricing
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-003 Sep 26, 1997 See Plans and Pricing See Plans and Pricing
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-001 May 17, 2007 See Plans and Pricing See Plans and Pricing
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-002 May 17, 2007 See Plans and Pricing See Plans and Pricing
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-006 Oct 4, 2005 See Plans and Pricing See Plans and Pricing
Astrazeneca SEROQUEL XR quetiapine fumarate TABLET, EXTENDED RELEASE;ORAL 022047-004 May 17, 2007 See Plans and Pricing See Plans and Pricing
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-005 Jul 26, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Dow
McKesson
AstraZeneca
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 verification 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.