.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Deloitte
Queensland Health
Citi
McKinsey
Fuji
Dow
Fish and Richardson
US Army
US Department of Justice

Generated: December 16, 2017

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

Summary for 022008

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Therapeutic Class:Antiparkinson Agents
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)

Summary 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:
Patent:► SubscribePatent 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:► SubscribePatent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022008

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-004Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-002Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-006Apr 10, 2009► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 2008► Subscribe► 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 plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Novartis
Argus Health
Daiichi Sankyo
McKinsey
Farmers Insurance
Boehringer Ingelheim
Cantor Fitzgerald
US Department of Justice

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot