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Generated: September 26, 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?

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, Epic Pharma Llc, 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 four 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-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: GLIMEPIRIDE

Tradenames:6
Patents:4
Applicants:21
NDAs:22
Drug Master File Entries: see list14
Suppliers / Packagers: see list43
Bulk Api Vendors: see list78
Clinical Trials: see list185
Patent Applications: see list5,264
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
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Carlsbad
GLIMEPIRIDE
glimepiride
TABLET;ORAL077911-003Sep 22, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
GLIMEPIRIDE
glimepiride
TABLET;ORAL078181-001Aug 23, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
glimepiride; rosiglitazone maleate
TABLET;ORAL078709-005Apr 1, 2016RXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
glimepiride; rosiglitazone maleate
TABLET;ORAL078709-001Apr 1, 2016RXNoYes► Subscribe► Subscribe► Subscribe
Mylan
GLIMEPIRIDE
glimepiride
TABLET;ORAL077486-002Feb 10, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
GLIMEPIRIDE
glimepiride
TABLET;ORAL076995-003Apr 27, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
GLIMEPIRIDE
glimepiride
TABLET;ORAL077091-002Oct 6, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
GLIMEPIRIDE
glimepiride
TABLET;ORAL077624-002Nov 28, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
GLIMEPIRIDE
glimepiride
TABLET;ORAL078181-002Aug 23, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Micro Labs Ltd India
GLIMEPIRIDE
glimepiride
TABLET;ORAL091220-003Jun 29, 2012RXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: glimepiride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AMARYL
glimepiride
TABLET;ORAL020496-001Nov 30, 1995► Subscribe► Subscribe
Sanofi Aventis Us
AMARYL
glimepiride
TABLET;ORAL020496-003Nov 30, 1995► Subscribe► Subscribe
Sanofi Aventis Us
AMARYL
glimepiride
TABLET;ORAL020496-002Nov 30, 1995► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
Novartis
Merck
US Army
Citi
Cantor Fitzgerald
AstraZeneca
Teva
UBS
Johnson and Johnson

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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