Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Johnson and Johnson
Queensland Health
QuintilesIMS
Mallinckrodt
Federal Trade Commission
Merck
Farmers Insurance
UBS

Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022008

« Back to Dashboard

NDA 022008 describes REQUIP XL, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the REQUIP XL profile page.

The generic ingredient in REQUIP XL 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 022008
Tradename:REQUIP XL
Applicant:Glaxosmithkline Llc
Ingredient:ropinirole hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022008
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 022008
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008 NDA GlaxoSmithKline LLC 0007-4882 0007-4882-13 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4882-13)
REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008 NDA GlaxoSmithKline LLC 0007-4883 0007-4883-13 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4883-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 2MG BASE
Approval Date:Jun 13, 2008TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Mar 23, 2020
Regulatory Exclusivity Use:PROVIDES FOR REVISIONS TO THE PACKAGE INSERT TO REFLECT RESULTS OF TWO POSTMARKETING REQUIREMENT STUDIES ROP111662 AND ROP111569
Patent:➤ Sign UpPatent Expiration:Dec 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT
Patent:➤ Sign UpPatent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022008

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-004 Jun 13, 2008 ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-001 Jun 13, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, 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:

UBS
Merck
McKinsey
Teva
Daiichi Sankyo
Farmers Insurance
Argus Health
Queensland Health
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.