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Generated: May 25, 2017

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GLIMEPIRIDE - Generic Drug Details

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What are the generic drug sources for glimepiride and what is the scope of glimepiride patent protection?

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

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
Micro Labs Ltd India
TABLET;ORAL091220-004Jun 29, 2012ABRXNoNo► Subscribe► Subscribe
TABLET;ORAL077911-002Sep 22, 2009ABRXNoNo► Subscribe► Subscribe
Prinston Inc
TABLET;ORAL077370-003Dec 23, 2005ABRXNoNo► Subscribe► Subscribe
Watson Labs
TABLET;ORAL077280-001Feb 3, 2006DISCNNoNo► Subscribe► Subscribe
Sb Pharmco
glimepiride; rosiglitazone maleate
TABLET;ORAL021700-004Mar 30, 2007DISCNYesNo7,358,366*PED► SubscribeY► Subscribe
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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.

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