.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020639

« Back to Dashboard
NDA 020639 describes SEROQUEL, which 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. Additional details are available on the SEROQUEL profile page.

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 nineteen tentative approvals for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for NDA: 020639

Tradename:
SEROQUEL
Applicant:
Astrazeneca Pharms
Ingredient:
quetiapine fumarate
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020639

Suppliers and Packaging for NDA: 020639

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEROQUEL
quetiapine fumarate
TABLET;ORAL 020639 NDA AstraZeneca Pharmaceuticals LP 0310-0271 0310-0271-10 100 TABLET, FILM COATED in 1 BOTTLE (0310-0271-10)
SEROQUEL
quetiapine fumarate
TABLET;ORAL 020639 NDA AstraZeneca Pharmaceuticals LP 0310-0271 0310-0271-39 100 BLISTER PACK in 1 CARTON (0310-0271-39) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Sep 26, 1997TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Sep 26, 1997TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Sep 26, 1997TE:ABRLD:No

Expired Orange Book Patents for NDA: 020639

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;ORAL020639-003Sep 26, 19974,879,288*PED► subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-006Oct 4, 20054,879,288*PED► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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 verifification 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.

`abc