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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Argus Health
Cantor Fitzgerald
Boehringer Ingelheim
Chinese Patent Office

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020658

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NDA 020658 describes REQUIP, which is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and nine Paragraph IV challenges. Additional details are available on the REQUIP profile page.

The generic ingredient in REQUIP is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 020658
Applicant:Glaxosmithkline Llc
Ingredient:ropinirole hydrochloride
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020658
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 020658
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REQUIP ropinirole hydrochloride TABLET;ORAL 020658 NDA GlaxoSmithKline LLC 0007-4890 N 0007-4890-20
REQUIP ropinirole hydrochloride TABLET;ORAL 020658 NDA GlaxoSmithKline LLC 0007-4891 N 0007-4891-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:Sep 19, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Sep 19, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Sep 19, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020658

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
US Army
Express Scripts

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