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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Teva
Healthtrust
Baxter
AstraZeneca
Farmers Insurance
Julphar
QuintilesIMS
McKesson

Generated: August 15, 2018

DrugPatentWatch Database Preview

LEVEMIR FLEXPEN Drug Profile

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When do Levemir Flexpen patents expire, and when can generic versions of Levemir Flexpen launch?

Levemir Flexpen is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and twenty-four patent family members in thirty countries.

The generic ingredient in LEVEMIR FLEXPEN is insulin detemir recombinant. There are forty 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.

Drug patent expirations by year for LEVEMIR FLEXPEN
Pharmacology for LEVEMIR FLEXPEN
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for LEVEMIR FLEXPEN

US Patents and Regulatory Information for LEVEMIR FLEXPEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for LEVEMIR FLEXPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Try a Free Trial
6,235,004 Injection syringe ➤ Try a Free Trial
6,869,930 Acylated insulin ➤ Try a Free Trial
6,582,404 Dose setting limiter ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LEVEMIR FLEXPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00020 Denmark ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
2107069/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
C0035 France ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
2013000062 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Deloitte
Covington
Federal Trade Commission
Dow
Cipla
Express Scripts
Baxter
Chubb

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