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Profile for Tradename: APIDRA

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Apidra is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug.

The generic ingredient in APIDRA is insulin glulisine recombinant. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

Summary for Tradename: APIDRA

Suppliers: see list1

Pharmacology for Tradename: APIDRA

Drug ClassInsulin Analog

Clinical Trials for: APIDRA

Comparison of Apidra to Regular Insulin in Hospitalized Patients
Status: Completed Condition: Diabetes Mellitus, Type II

Insulin Glargine "All to Target" Trial
Status: Completed Condition: Diabetes Mellitus, Type 2

Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
Status: Terminated Condition: Diabetes Type 1

The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Status: Completed Condition: Type 1 Diabetes Mellitus

Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
Status: Completed Condition: Diabetes

Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
Status: Recruiting Condition: Diabetes During Pregnancy

Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Status: Active, not recruiting Condition: Type 2 Diabetes

Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting
Status: Terminated Condition: Diabetes Mellitus, Type 2

Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus

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See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Sanofi Aventis Us
insulin glulisine recombinant
INJECTABLE; IV (INFUSION)-SC021629Apr 16, 2004RXYes<disabled><disabled>
Sanofi Aventis Us
insulin glulisine recombinant
INJECTABLE; IV (INFUSION)-SC021629Dec 20, 2005RXYes<disabled><disabled>
Sanofi Aventis Us
insulin glulisine recombinant
INJECTABLE; IV (INFUSION)-SC021629Apr 16, 2004RXYes6,221,633<disabled><disabled>
Sanofi Aventis Us
insulin glulisine recombinant
INJECTABLE; IV (INFUSION)-SC021629Dec 20, 2005RXYes6,960,561<disabled><disabled>
Sanofi Aventis Us
insulin glulisine recombinant
INJECTABLE; IV (INFUSION)-SC021629Dec 20, 2005RXYes6,221,633<disabled><disabled>
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