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LEVEMIR Drug Profile

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

This drug has seventy-three patent family members in twenty-eight countries.

The generic ingredient in LEVEMIR 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

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: LEVEMIR

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: LEVEMIR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005RXYes5,750,497<disabled>YY <disabled>
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005DISCNNo5,750,497<disabled>YY <disabled>
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoRE41956<disabled>Y <disabled>
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Expired Patents for Tradename: LEVEMIR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 20056,011,007<disabled>
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 20056,869,930<disabled>
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Non-Orange Book Patents for Tradename: LEVEMIR

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>
6,869,930 Acylated insulin<disabled in preview>
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International Patent Family for Tradename: LEVEMIR

Country Document Number Estimated Expiration
Romania112873<disabled in preview>
China1056618<disabled in preview>
South Africa9407187<disabled in preview>
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Supplementary Protection Certificates for Tradename: LEVEMIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90029-5Sweden<disabled>PRODUCT NAME: INSULIN DEGLUDEK; REG. NO/DATE: EU/1/12/807/001 20130121
2107069/01Switzerland<disabled>PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
C0009France<disabled>PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
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