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Generated: November 20, 2018

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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.

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 PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR INNOLET insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-003 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-001 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXPEN insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-002 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR FLEXTOUCH insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-005 Oct 31, 2013 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc LEVEMIR PENFILL insulin detemir recombinant INJECTABLE;SUBCUTANEOUS 021536-004 Jun 16, 2005 ➤ Sign Up ➤ Sign Up
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
Norway 20021312 ➤ Sign Up
Russian Federation 2011118236 ➤ Sign Up
World Intellectual Property Organization (WIPO) 2006079481 ➤ Sign Up
Finland 117055 ➤ Sign Up
China 101107032 ➤ Sign Up
South Korea 20070084393 ➤ Sign Up
China 1277558 ➤ Sign Up
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
00596 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2017000040 Germany ➤ Sign Up PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2017 00020 Denmark ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
C/GB04/036 United Kingdom ➤ Sign Up 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
C0044 Belgium ➤ Sign Up PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Moodys
Julphar
Queensland Health
Fish and Richardson
Citi
Teva
Fuji
Chinese Patent Office

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