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Last Updated: December 14, 2019

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LEVEMIR INNOLET Drug Profile

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

Levemir Innolet is a drug marketed by Novo Nordisk Inc and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in LEVEMIR INNOLET 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.

US ANDA Litigation and Generic Entry Outlook for Levemir Innolet

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

Summary for LEVEMIR INNOLET
International Patents:47
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Bulk Api Vendors: 2
Formulation / Manufacturing:see details
DailyMed Link:LEVEMIR INNOLET at DailyMed
Drug patent expirations by year for LEVEMIR INNOLET
Pharmacology for LEVEMIR INNOLET
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for LEVEMIR INNOLET
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
Levemir Flexpen
Levemir Insulin
Levemir Penfill
NN 304
NN-304
NN304
UNII-4FT78T86XV

US Patents and Regulatory Information for LEVEMIR INNOLET

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 INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 DISCN No No   Start Trial   Start Trial Y 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 INNOLET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005   Start Trial   Start Trial
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEVEMIR INNOLET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 CA 2004 00029 Denmark   Start Trial
2340033 2017C/024 Belgium   Start Trial PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
0792290 C300160 Netherlands   Start Trial PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
0705275 C300021 Netherlands   Start Trial PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
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
2107069 SPC/GB13/037 United Kingdom   Start Trial PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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