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

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
UBS
Chinese Patent Office
Daiichi Sankyo
Julphar
Colorcon
Queensland Health
Cipla

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020658

« Back to Dashboard

NDA 020658 describes REQUIP, which is a drug marketed by Glaxosmithkline Llc and is included in two NDAs. It is available from two 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 suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Summary for 020658
Tradename:REQUIP
Applicant:Glaxosmithkline Llc
Ingredient:ropinirole hydrochloride
Patents:0
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-002 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-001 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-003 Sep 19, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Argus Health
Johnson and Johnson
McKesson
Merck
Healthtrust
QuintilesIMS
Accenture
Cerilliant

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.