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Generated: February 16, 2019

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INSULIN DETEMIR RECOMBINANT - Generic Drug Details

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What are the generic drug sources for insulin detemir recombinant and what is the scope of insulin detemir recombinant patent protection?

Insulin detemir recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin detemir recombinant has two hundred and twenty patent family members in thirty countries.

There are forty drug master file entries for insulin detemir recombinant. Four suppliers are listed for this compound.

Pharmacology for INSULIN DETEMIR RECOMBINANT
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for INSULIN DETEMIR RECOMBINANT
Synonyms for INSULIN DETEMIR RECOMBINANT
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
D0QE5U
Insulin detemir
Insulin detemir [USAN:INN:BAN]
Insulin-detemir
Levemir
Levemir Flexpen
Levemir Innolet
Levemir Insulin
Levemir Penfill
NN 304
NN-304
NN304
UNII-4FT78T86XV

US Patents and Regulatory Information for INSULIN DETEMIR RECOMBINANT

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 FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for INSULIN DETEMIR RECOMBINANT

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 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for INSULIN DETEMIR RECOMBINANT

Country Document Number Estimated Expiration
European Patent Office 1250167 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 2010046394 ➤ Try a Free Trial
Austria 197408 ➤ Try a Free Trial
Denmark 1843809 ➤ Try a Free Trial
Austria 444090 ➤ Try a Free Trial
Norway 20001559 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for INSULIN DETEMIR RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2017 Austria ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGIN UND LIXISENATID; REGISTRATION NO/DATE: EU/1/16/1157 (MITTEILUNG) 20170113
C/GB04/036 United Kingdom ➤ Try a Free Trial PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
34/2000 Austria ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
C/GB05/024 United Kingdom ➤ Try a Free Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
0883 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
60026 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Cipla
Healthtrust
Mallinckrodt
Cerilliant
Chubb
Moodys
Deloitte
McKesson

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