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LEVEMIR INNOLET Drug Profile

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

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

The generic ingredient in LEVEMIR INNOLET 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 INNOLET

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: LEVEMIR INNOLET

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: LEVEMIR INNOLET

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005DISCNNo5,750,497<disabled>YY <disabled>
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005DISCNNo5,866,538<disabled>YY <disabled>
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Expired Patents for Tradename: LEVEMIR INNOLET

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 20056,011,007<disabled>
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 20056,869,930<disabled>
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Non-Orange Book Patents for Tradename: LEVEMIR INNOLET

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 INNOLET

Country Document Number Estimated Expiration
Japan2000513344<disabled in preview>
World Intellectual Property Organization (WIPO)9748414<disabled in preview>
Norway985981<disabled in preview>
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Supplementary Protection Certificates for Tradename: LEVEMIR INNOLET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/034Ireland<disabled>PRODUCT NAME: INSULIN DEGLUDEC; NATL. REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121; FIRST REGISTRATION: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121
C/GB04/036United Kingdom<disabled>PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
C015/2004Ireland<disabled>SPC015/2004, 20060131, EXPIRES: 20181109
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