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Profile for Tradename: LEVEMIR FLEXPEN

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Levemir Flexpen is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug.

This drug has one hundred and thirty patent family members in thirty countries.

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

Summary for Tradename: LEVEMIR FLEXPEN

Patents:5
Applicants:1
NDAs:1
Suppliers: see list3

Pharmacology for Tradename: LEVEMIR FLEXPEN

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: LEVEMIR FLEXPEN

Observational Study of Patients With Diabetes Using Levemir® FlexPen®
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 2

The Effects of Insulin Detemir and Gliclazide-MR Treatments on Endothelial Functions in Patients With Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics
Status: Completed Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005RXYes5,866,538<disabled>YY<disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005RXYesRE41956<disabled>Y<disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005RXYes5,750,497<disabled>YY<disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005RXYes6,004,297<disabled>Y<disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005RXYesRE43834<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: LEVEMIR FLEXPEN

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
6,235,004 Injection syringe<disabled in preview>
6,582,404 Dose setting limiter<disabled in preview>
6,869,930 Acylated insulin<disabled in preview>
6,011,007 Acylated insulin<disabled in preview>
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International Patent Family for Tradename: LEVEMIR FLEXPEN

Country Document Number Publication Date
Austria299728Aug 15, 2005
Poland196742Jan 31, 2008
Poland341395Apr 09, 2001
China1133598Oct 16, 1996
Czech Republic9803956May 12, 1999
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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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