You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Baxter
Colorcon
McKinsey
Express Scripts

Last Updated: March 31, 2020

DrugPatentWatch Database Preview

LEVEMIR Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Levemir, and what generic alternatives are available?

Levemir is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are twenty-four 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. 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

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

Annual sales in 2017 were $3.9bn, indicating a strong incentive for generic entry (peak sales were $4.0bn in 2015).

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

< Available with Subscription >

  Start Trial

Drug patent expirations by year for LEVEMIR
Drug Prices for LEVEMIR

See drug prices for LEVEMIR

Drug Sales Revenue Trends for LEVEMIR

See drug sales revenues for LEVEMIR

Recent Clinical Trials for LEVEMIR

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

SponsorPhase
Minneapolis Medical Research FoundationN/A
Albany College of Pharmacy and Health SciencesN/A
University of California, San FranciscoN/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
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 PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 DISCN No No   Start Trial   Start Trial Y Y   Start Trial
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
0368187 0091020-8 0090020-9 Sweden   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
2209800 122014000114 Germany   Start Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2498802 2017/022 Ireland   Start Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
2340033 2017C/024 Belgium   Start Trial PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
0214826 C990042 Netherlands   Start Trial PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
0792290 PA2004005,C0792290 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Baxter
Colorcon
McKinsey
Express Scripts

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.