Make Better Decisions

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Express Scripts
QuintilesIMS
Argus Health
Cerilliant
Moodys
Farmers Insurance
Novartis
Colorcon
Julphar
Dow

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090429

« Back to Dashboard

NDA 090429 describes ROPINIROLE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz Inc, Watson Labs Inc, Wockhardt Ltd, Accord Hlthcare, Alembic Ltd, Apotex, Epic Pharma Llc, G And W Labs Inc, Glenmark Generics, Mylan, Orchid Hlthcare, Prinston Inc, West-ward Pharms Int, Wockhardt, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from thirty-one suppliers. Additional details are available on the ROPINIROLE HYDROCHLORIDE profile page.

The generic ingredient in ROPINIROLE HYDROCHLORIDE 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 090429
Tradename:ROPINIROLE HYDROCHLORIDE
Applicant:Alembic Ltd
Ingredient:ropinirole hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090429
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 090429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090429 ANDA Major Pharmaceuticals 0904-6373 0904-6373-61 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6373-61)
ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET;ORAL 090429 ANDA Major Pharmaceuticals 0904-6374 0904-6374-61 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6374-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.25MG BASE
Approval Date:Mar 24, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:Mar 24, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Mar 24, 2010TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Argus Health
McKinsey
UBS
Daiichi Sankyo
Dow
Colorcon
Queensland Health

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.

botpot