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Mallinckrodt
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US Army
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Generated: January 16, 2019

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Insulin susp isophane recombinant human - Generic Drug Details

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

Insulin susp isophane recombinant human is the generic ingredient in two branded drugs marketed by Lilly and Novo Nordisk Inc, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin susp isophane recombinant human has twelve patent family members in nine countries.

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

Summary for insulin susp isophane recombinant human
International Patents:12
US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 40
Suppliers / Packagers: 4
Clinical Trials: 8
DailyMed Link:insulin susp isophane recombinant human at DailyMed

US Patents and Regulatory Information for insulin susp isophane recombinant human

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 NOVOLIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 019959-001 Jul 1, 1991 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly HUMULIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 018781-001 Oct 28, 1982 OTC 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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Supplementary Protection Certificates for insulin susp isophane recombinant human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2/2005 Austria ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE
/2005 Austria ➤ Sign Up PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
2017 00020 Denmark ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
C0009 France ➤ Sign Up 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
0883 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Fuji
Harvard Business School
Chubb
Argus Health
Colorcon
Dow
McKinsey

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