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Last Updated: March 28, 2020

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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-five patent family members in thirty countries.

The generic ingredient in LEVEMIR FLEXPEN is insulin detemir recombinant. There are forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin detemir recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Levemir Flexpen

Levemir Flexpen was eligible for patent challenges on June 16, 2009.

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 LEVEMIR FLEXPEN
Drug Sales Revenue Trends for LEVEMIR FLEXPEN

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Recent Clinical Trials for LEVEMIR FLEXPEN

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

SponsorPhase
Ankara UniversityN/A
Hacettepe UniversityN/A
TubitakN/A

See all LEVEMIR FLEXPEN clinical trials

Recent Litigation for LEVEMIR 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 LEVEMIR FLEXPEN litigation

PTAB Litigation
PetitionerDate
2014-01-23

See all LEVEMIR FLEXPEN litigation

Pharmacology for LEVEMIR FLEXPEN
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for LEVEMIR FLEXPEN
169148-63-4
29(sup B)-(N(sup 6)-(1-Oxotetradecyl)-L-lysine)-(1(sup A)-21(sup A)),(1(sup B)-29(sup B))-insulin (human)
29(sup B)-(N(sup 6)-Myristoyl-L-lysine)-30(sup B)-de-L-threonineinsulin (human)
29B-(N6-Myristoyl-L-lysine)-30B-de-L-threonineinsulin (human)
4FT78T86XV
CHEMBL2104391
Insulin detemir
Insulin detemir [USAN:INN:BAN]
INSULIN DETEMIR RECOMBINANT
Levemir
Levemir Innolet
Levemir Insulin
Levemir Penfill
NN 304
NN-304
NN304
UNII-4FT78T86XV

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   Start Trial   Start Trial Y Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No   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 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   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEVEMIR FLEXPEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 2013/034 Ireland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
2107069 92213 Luxembourg   Start Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
2107069 132013902170499 Italy   Start Trial PRODUCT NAME: INSULINA DEGLUDEC(TRESIBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/807/001-4-5-7-8-9-12-13-15, 20130121
0368187 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
McKesson
Colorcon
Express Scripts
Dow

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