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Generated: May 27, 2017

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Glimepiride - Generic Drug Details

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What are the generic sources for glimepiride and what is the scope of glimepiride freedom to operate?

Glimepiride
is the generic ingredient in six branded drugs marketed by Teva, Carlsbad, Indoco Remedies, Micro Labs Ltd India, Mylan, Hikma Pharms, Aurobindo Pharma Ltd, Ranbaxy, Prinston Inc, Corepharma, Ranbaxy Labs Ltd, Watson Labs, Accord Hlthcare, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Invagen Pharms, Sanofi Aventis Us, Takeda Pharms Usa, Sandoz, Sb Pharmco, and Teva Pharms Usa, and is included in twenty-two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for glimepiride. Forty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: glimepiride

Tradenames:6
Patents:5
Applicants:21
NDAs:22
Drug Master File Entries: see list14
Suppliers / Packagers: see list44
Bulk Api Vendors: see list78
Clinical Trials: see list69
Patent Applications: see list5,642
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:glimepiride at DailyMed

Pharmacology for Ingredient: glimepiride

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Tentative approvals for GLIMEPIRIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe1MGTABLET;ORAL
► Subscribe► Subscribe8MGTABLET;ORAL
► Subscribe► Subscribe4MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
GLIMEPIRIDE
glimepiride
TABLET;ORAL202759-002Jun 29, 2012ABRXNoNo► Subscribe► Subscribe
Sb Pharmco
AVANDARYL
glimepiride; rosiglitazone maleate
TABLET;ORAL021700-004Mar 30, 2007DISCNYesNo7,358,366*PED► SubscribeY► Subscribe
Corepharma
GLIMEPIRIDE
glimepiride
TABLET;ORAL077274-003Oct 6, 2005DISCNNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
GLIMEPIRIDE
glimepiride
TABLET;ORAL202759-003Jun 29, 2012ABRXNoNo► Subscribe► Subscribe
Takeda Pharms Usa
DUETACT
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925-001Jul 28, 2006ABRXYesYes6,303,640► Subscribe ► Subscribe
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