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Insulin detemir recombinant - Generic Drug Details

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Insulin detemir recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and seventeen patent family members in thirty countries.

There are thirty-eight drug master file entries for insulin detemir recombinant. Three suppliers are listed for this compound.

Summary for Generic Name: insulin detemir recombinant

Tradenames:5
Patents:13
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: insulin detemir recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: insulin detemir recombinant

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, 2005DISCNNo5,866,538<disabled>YY <disabled>
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYes5,866,538<disabled>Y <disabled>
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005DISCNNo5,866,538<disabled>YY <disabled>
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Expired Orange Book Patents for Generic Ingredient: insulin detemir recombinant

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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, 20056,869,930<disabled>
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 20056,869,930<disabled>
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 20056,011,007<disabled>
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Non-Orange Book Patents for Generic Ingredient: insulin detemir recombinant

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
6,869,930 Acylated insulin<disabled in preview>
8,357,120Injection device with torsion spring and rotatable display<disabled in preview>
6,235,004 Injection syringe<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 Ingredient: insulin detemir recombinant

Country Document Number Estimated Expiration
Spain2334808<disabled in preview>
Hungary217684<disabled in preview>
Portugal921812<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: INSULIN DETEMIR RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90036-0Sweden<disabled>PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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
0885961/01Switzerland<disabled>PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
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