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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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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LEVEMIR

Country Document Number Estimated Expiration
HungaryT75991<disabled in preview>
Poland189964<disabled in preview>
Spain2163451<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LEVEMIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/34Ireland<disabled>PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
213Luxembourg<disabled>PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
C015/2004Ireland<disabled>SPC015/2004, 20060131, EXPIRES: 20181109
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