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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Teva
Queensland Health
Express Scripts
Cerilliant
Covington
Deloitte
AstraZeneca

Generated: June 20, 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 thirty-nine drug master file entries for this compound. Four 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
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
6,582,404 Dose setting limiter ➤ Try a Free Trial
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
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
2017000040 Germany ➤ Try a Free Trial PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
C0009 France ➤ Try a Free Trial 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
/2004 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
90042 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Healthtrust
Cerilliant
Citi
Merck
Harvard Business School
AstraZeneca
Chubb
Colorcon

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