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Last Updated: November 12, 2019

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LEVEMIR Drug Profile

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

Levemir is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are twenty-three patents protecting this drug.

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

The generic ingredient in LEVEMIR is insulin detemir 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 detemir recombinant profile page.

Drug patent expirations by year for LEVEMIR
Drug Prices for LEVEMIR

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Drug Sales Revenue Trends for LEVEMIR

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Recent Clinical Trials for LEVEMIR

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SponsorPhase
Minneapolis Medical Research FoundationN/A
University of California, San FranciscoN/A
Albany College of Pharmacy and Health SciencesN/A

See all LEVEMIR clinical trials

Recent Litigation for LEVEMIR

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
Elam Electroluminescent Industries, Ltd. v. Rhode Island Novelty, Inc.2005-07-11

See all LEVEMIR litigation

Pharmacology for LEVEMIR
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for LEVEMIR
169148-63-4
201305-44-4
270588-25-5
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 Flexpen
Levemir Innolet
Levemir Insulin
Levemir Penfill
NN 304
NN-304
NN304
UNII-4FT78T86XV

US Patents and Regulatory Information for LEVEMIR

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 insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes   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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEVEMIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885961 05C0009 France   Start Trial PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
2209800 122014000114 Germany   Start Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
0792290 PA2004005 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR
2340033 300880 Netherlands   Start Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2107069 C 2013 019 Romania   Start Trial PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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