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Generated: December 13, 2017

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-three suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for 020658

Tradename:1
Applicant:1
Ingredient:1
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 0007-4890-20 100 TABLET, FILM COATED in 1 BOTTLE (0007-4890-20)
REQUIP ropinirole hydrochloride TABLET;ORAL 020658 NDA GlaxoSmithKline LLC 0007-4891 0007-4891-20 100 TABLET, FILM COATED in 1 BOTTLE (0007-4891-20)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020658

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-004Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-007Jan 27, 1999► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-001Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-004Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-005Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-006Jan 27, 1999► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-003Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-002Sep 19, 1997► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-006Jan 27, 1999► Subscribe► Subscribe
Glaxosmithkline LlcREQUIPropinirole hydrochlorideTABLET;ORAL020658-003Sep 19, 1997► Subscribe► Subscribe
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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.

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