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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Medtronic
McKesson
Baxter
Farmers Insurance
US Army
Deloitte
Fuji
Cantor Fitzgerald

Generated: April 20, 2018

DrugPatentWatch Database Preview

NOVOLOG FLEXPEN Drug Profile

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Which patents cover Novolog Flexpen, and when can generic versions of Novolog Flexpen launch?

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

This drug has seventy-seven patent family members in twenty-two countries.

The generic ingredient in NOVOLOG FLEXPEN is insulin aspart recombinant. There are thirty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.
Summary for NOVOLOG FLEXPEN
International Patents:77
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Clinical Trials: 41
Drug Prices:see details
DailyMed Link:NOVOLOG FLEXPEN at DailyMed
Drug patent expirations by year for NOVOLOG FLEXPEN
Pharmacology for NOVOLOG FLEXPEN
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for NOVOLOG FLEXPEN

US Patents and Regulatory Information for NOVOLOG 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 NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 NOVOLOG FLEXPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for NOVOLOG 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
6,235,004 Injection syringe ➤ Sign Up
6,582,404 Dose setting limiter ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NOVOLOG FLEXPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2013000062 Germany ➤ Sign Up 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
C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Baxter
Daiichi Sankyo
Express Scripts
Farmers Insurance
Cipla
Cerilliant
Chinese Patent Office

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