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Last Updated: April 6, 2020

DrugPatentWatch Database Preview

NOVOLOG MIX 70/30 FLEXPEN Drug Profile


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Which patents cover Novolog Mix 70/30 Flexpen, and what generic alternatives are available?

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. Four 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.

Indicators of Generic Entry

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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

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

PTAB Litigation
PetitionerDate
2014-01-23

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
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 C02107069/02 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2107069 300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
0885961 SZ 2/2005 Austria   Start Trial PRODUCT NAME: INSULIN GLULISINE
2107069 C300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
0792290 28/2004 Austria   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Merck
AstraZeneca
Mallinckrodt
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.