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Profile for Tradename: LANTUS

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Lantus is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from five suppliers. There are ten patents protecting this drug.

The generic ingredient in LANTUS is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for Tradename: LANTUS

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list11
2013 Sales:$2,556,825,000

Pharmacology for Tradename: LANTUS

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: LANTUS

Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
Status: Completed Condition: Hyperglycemia; Diabetes

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

Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes
Status: Not yet recruiting Condition: Type 1 Diabetes; Hypoglycemia

The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes Mellitus

Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)
Status: Completed Condition: Diabetes Mellitus, Type 1

Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Status: Recruiting Condition: Type 2 Diabetes; Renal Insufficiency

A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 1

A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes Mellitus, Type 2

Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Status: Completed Condition: Type 2 Diabetes Mellitus

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
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000RXYes7,918,833*PED<disabled>Y<disabled>
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYes8,512,297<disabled>Y<disabled>
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000RXYes5,656,722*PED<disabled>Y<disabled>
Sanofi Aventis Us
LANTUS SOLOSTAR
insulin glargine recombinant
INJECTABLE;INJECTION021081-002Apr 27, 2007RXYes8,679,069<disabled>Y<disabled>
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000RXYes7,713,930*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: LANTUS

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
8,070,727Drive mechanisms suitable for use in drug delivery devices<disabled in preview>
8,574,198Drive mechanisms suitable for use in drug delivery devices<disabled in preview>
8,556,864Drive mechanisms suitable for use in drug delivery devices<disabled in preview>
7,553,299Drive mechanisms suitable for use in drug delivery devices<disabled in preview>
8,603,044Pen-type injector<disabled in preview>
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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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