Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
➤ Start Trial

or, See Plans & Pricing

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

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
Daiichi Sankyo

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091220

« Back to Dashboard

NDA 091220 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Invagen Pharms, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, Viva Hlthcare, and Watson Labs, and is included in seventeen NDAs. It is available from forty-three suppliers. Additional details are available on the GLIMEPIRIDE profile page.

The generic ingredient in GLIMEPIRIDE is glimepiride. There are fifteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 091220
Applicant:Viva Hlthcare
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 091220
Ingredient-typeSulfonylurea Compounds
Suppliers and Packaging for NDA: 091220
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 091220 ANDA Aidarex Pharmaceuticals LLC 33261-831 N 33261-831-99
GLIMEPIRIDE glimepiride TABLET;ORAL 091220 ANDA Micro Labs Limited 42571-100 N 42571-100-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 29, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 29, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jun 29, 2012TE:RLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts
Daiichi Sankyo
Harvard Business School
Chinese Patent Office

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.