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LEVEMIR FLEXPEN Drug Profile

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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 six patents protecting this drug.

This drug has one hundred and forty-three 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:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: LEVEMIR FLEXPEN

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: LEVEMIR FLEXPEN

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, 2005DISCNNo5,750,497<disabled>YY <disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNo5,866,538<disabled>YY <disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoRE43834<disabled>Y <disabled>
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Expired Patents for Tradename: LEVEMIR FLEXPEN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 20056,011,007<disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 20056,869,930<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
6,011,007 Acylated insulin<disabled in preview>
6,235,004 Injection syringe<disabled in preview>
6,582,404 Dose setting limiter<disabled in preview>
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International Patent Family for Tradename: LEVEMIR FLEXPEN

Country Document Number Estimated Expiration
China1277558<disabled in preview>
European Patent Office1570876<disabled in preview>
Canada2258097<disabled in preview>
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Supplementary Protection Certificates for Tradename: LEVEMIR FLEXPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00596Netherlands<disabled>PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
90042Netherlands<disabled>PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
C0020France<disabled>PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
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