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SEROQUEL Drug Profile

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Seroquel is a drug marketed by Astrazeneca Pharms and Astrazeneca and is included in two NDAs. It is available from eleven suppliers. There is one patent protecting this drug and seven Paragraph IV challenges.

The generic ingredient in SEROQUEL is quetiapine fumarate. There are fifty drug master file entries for this compound. Fifty-two suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for Tradename: SEROQUEL

Patents:1
Applicants:2
NDAs:2
Suppliers / Packagers: see list11
Drug Prices: :see details

Pharmacology for Tradename: SEROQUEL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-001Sep 26, 1997RXYes► subscribe► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-006Oct 4, 2005RXNo► subscribe► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-004Dec 20, 1998DISCNNo► subscribe► subscribe
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Expired Patents for Tradename: SEROQUEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-001Sep 26, 19974,879,288*PED► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-005Jul 26, 20004,879,288*PED► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-007Oct 4, 20054,879,288*PED► subscribe
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Paragraph IV activity for: SEROQUEL

Drugname Dosage Strength RLD Submissiondate
quetiapine fumarateExtended-release Tablets150 mgSeroquel XR11/17/2008
quetiapine fumarateExtended-release Tablets50 mgSeroquel XR10/17/2008
quetiapine fumarateExtended-release Tablets400 mgSeroquel XR6/18/2008
quetiapine fumarateTablets200 mg and 300 mgSeroquel XR6/12/2008
quetiapine fumarateTablets50 mg, 150 mg and 400 mgSeroquel2/12/2007
quetiapine fumarateTablets100 mg, 200 mg and 300 mgSeroquel2/21/2006
quetiapine fumarateTablets25 mgSeroquel8/12/2005
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