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Last Updated: January 22, 2020

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NOVOLOG MIX 70/30 FLEXPEN Drug Profile

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When do Novolog Mix 70/30 Flexpen patents expire, and when can generic versions of Novolog Mix 70/30 Flexpen launch?

Novolog Mix 70/30 Flexpen is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred patent family members in twenty-two countries.

The generic ingredient in NOVOLOG MIX 70/30 FLEXPEN is insulin aspart protamine recombinant; insulin aspart 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 aspart protamine recombinant; insulin aspart recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Novolog Mix 70/30 Flexpen

Novolog Mix 70/30 Flexpen was eligible for patent challenges on June 7, 2004.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

  Start Trial

Summary for NOVOLOG MIX 70/30 FLEXPEN
Drug patent expirations by year for NOVOLOG MIX 70/30 FLEXPEN
Recent Clinical Trials for NOVOLOG MIX 70/30 FLEXPEN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Texas Southwestern Medical CenterPhase 4
Novo Nordisk A/SPhase 4

See all NOVOLOG MIX 70/30 FLEXPEN clinical trials

Recent Litigation for NOVOLOG MIX 70/30 FLEXPEN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08
Novo Nordisk A/S v. Sanofi-Aventis2005-09-02

See all NOVOLOG MIX 70/30 FLEXPEN litigation

Pharmacology for NOVOLOG MIX 70/30 FLEXPEN
Drug ClassInsulin Analog

US Patents and Regulatory Information for NOVOLOG MIX 70/30 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 MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NOVOLOG MIX 70/30 FLEXPEN

Supplementary Protection Certificates for NOVOLOG MIX 70/30 FLEXPEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 35/2013 Austria   Start Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
2498802 C201730022 Spain   Start Trial PRODUCT NAME: SULIQUA-INSULINA GLARGINA/ LIXISENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1157; DATE OF AUTHORISATION: 20170111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1157; DATE OF FIRST AUTHORISATION IN EEA: 20170111
2107069 1390036-0 Sweden   Start Trial PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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