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Details for Generic Name: GLIMEPIRIDE

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Summary for Generic Name: GLIMEPIRIDE

Drug Master File Entries: see list14
Suppliers: see list1
Therapeutic Class:Blood Glucose Regulators

Pharmacology for Ingredient: GLIMEPIRIDE

Ingredient-typeSulfonylurea Compounds
Drug ClassSulfonylurea

Clinical Trials for: GLIMEPIRIDE

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
Status: Terminated Condition: Diabetes Mellitus, Type 2

A Comparison of Atorvastatin and Glimepiride Fixed Dose Combination and Atorvastatin and Glimepiride Loose Combination in the Treatment of Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 2

Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting Condition
Status: Completed Condition: Healthy

Bioequivalence Study of 4 mg Glimepiride Tablet
Status: Completed Condition: Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
Status: Completed Condition: Healthy

TAK-875 Glimepiride Drug-Interaction Study
Status: Completed Condition: Pharmacokinetics

Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Status: Completed Condition: Type 2 Diabetes Mellitus

Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers
Status: Completed Condition: Healthy

Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
Status: Completed Condition: Type 2 Diabetes Mellitus

An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
Status: Terminated Condition: Diabetes Mellitus, Type 2

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
glimepiride; pioglitazone hydrochloride
TABLET;ORAL021925Jul 28, 2006RXNo6,303,640<disabled><disabled>
Accord Hlthcare
TABLET;ORAL078181Aug 23, 2007RXNo<disabled><disabled>
Dr Reddys Labs Ltd
TABLET;ORAL077091Oct 6, 2005RXNo<disabled><disabled>
Micro Labs Ltd India
TABLET;ORAL091220Jun 29, 2012RXNo<disabled><disabled>
Aurobindo Pharma Ltd
TABLET;ORAL202759Jun 29, 2012RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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