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.

Summary for QUETIAPINE FUMARATE

US Patents:	0
Tradenames:	3
Applicants:	29
NDAs:	39
Drug Master File Entries:	48
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	207
Clinical Trials:	97
Patent Applications:	4,348
Drug Prices:	Drug price trends for QUETIAPINE FUMARATE
Drug Sales Revenues:	Drug sales revenues for QUETIAPINE FUMARATE
What excipients (inactive ingredients) are in QUETIAPINE FUMARATE?	QUETIAPINE FUMARATE excipients list
DailyMed Link:	QUETIAPINE FUMARATE at DailyMed

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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

Sponsor	Phase
The University of Texas Health Science Center at San Antonio	Early Phase 1
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all QUETIAPINE FUMARATE clinical trials

Pharmacology for QUETIAPINE FUMARATE

Drug Class	Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for QUETIAPINE FUMARATE

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for QUETIAPINE FUMARATE

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	077380-007	Mar 27, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET;ORAL	206954-004	Aug 24, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	QUETIAPINE FUMARATE	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	208947-001	Nov 29, 2017	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-004	May 17, 2007	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-005	Aug 11, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-003	May 17, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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