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Last Updated: February 29, 2020

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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 six patents protecting this drug.

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

The generic ingredient in NOVOLOG FLEXPEN is 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 recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Novolog Flexpen

Novolog 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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Drug patent expirations by year for NOVOLOG FLEXPEN
Drug Prices for NOVOLOG FLEXPEN

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Recent Clinical Trials for NOVOLOG FLEXPEN

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

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

See all NOVOLOG FLEXPEN clinical trials

Recent Litigation for NOVOLOG 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 FLEXPEN litigation

PTAB Litigation
PetitionerDate
2014-01-23

See all NOVOLOG FLEXPEN litigation

Pharmacology for NOVOLOG FLEXPEN
Drug ClassInsulin Analog
Synonyms for NOVOLOG FLEXPEN
1024611-56-0
116094-23-6
139532-40-4
D933668QVX
Fiasp
INA-X14
Insulin aspart
Insulin aspart [USAN:INN:BAN]
NN1218
Novolog Innolet
Novolog Penfill
NovoMix
UNII-D933668QVX

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   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 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 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   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001   Start Trial   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NOVOLOG FLEXPEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0705275 32/2000 Austria   Start Trial PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2107069 C02107069/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
0705275 41/2005 Austria   Start Trial PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
2340033 2017C/024 Belgium   Start Trial PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
2107069 2013C/038 Belgium   Start Trial PRODUCT NAME: RYZODEG-INSULINE DEGLUDEC/INSULINE ASPARTE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001 20130121
0705275 40/2005 Austria   Start Trial PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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