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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 eleven patents protecting this drug.

This drug has seventy-eight patent family members in thirty-nine countries.

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

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: APIDRA

Ingredient-typeInsulin
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

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

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

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

Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
Status: Active, not 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: Completed Condition: Type 2 Diabetes

Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin
Status: Completed Condition: Diabetes Mellitus, Type 2

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-001Apr 16, 2004RXYes6,221,633<disabled>YY <disabled>
Sanofi Aventis Us
APIDRA SOLOSTAR
insulin glulisine recombinant
INJECTABLE;SUBCUTANEOUS021629-003Feb 24, 2009RXNo7,452,860<disabled>Y <disabled>
Sanofi Aventis Us
APIDRA
insulin glulisine recombinant
INJECTABLE;IV (INFUSION), SUBCUTANEOUS021629-002Dec 20, 2005RXYes7,696,162<disabled>Y <disabled>
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Non-Orange Book Patents for Tradename: APIDRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,205,276Zinc-free and low-zinc insulin preparations having improved stability<disabled in preview>
7,205,277Zinc-free and low-zinc insulin preparations having improved stability<disabled in preview>
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International Patent Family for Tradename: APIDRA

Country Document Number Publication Date
CroatiaP20030765Oct 31, 2011
Poland362800Nov 02, 2004
Slovakia285267Oct 05, 2006
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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.

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ISSN: 2162-2639

Preferred citation:

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

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