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Last Updated: December 6, 2019

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Insulin recombinant human; insulin susp isophane recombinant human - Generic Drug Details

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What are the generic drug sources for insulin recombinant human; insulin susp isophane recombinant human and what is the scope of freedom to operate?

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

Insulin recombinant human; insulin susp isophane recombinant human has eighteen patent family members in fourteen countries.

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

Recent Clinical Trials for insulin recombinant human; insulin susp isophane recombinant human

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

SponsorPhase
Julphar Gulf Pharmaceutical IndustriesPhase 1
Profil Institut für Stoffwechselforschung GmbHPhase 1
Inova Health Care ServicesPhase 4

See all insulin recombinant human; insulin susp isophane recombinant human clinical trials

US Patents and Regulatory Information for insulin recombinant human; 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 70/30 insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 019991-001 Jun 25, 1991 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Lilly HUMULIN 70/30 PEN insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 019717-002 Aug 6, 1998 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Lilly HUMULIN 70/30 insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 019717-001 Apr 25, 1989 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Lilly HUMULIN 50/50 insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 020100-001 Apr 29, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for insulin recombinant human; insulin susp isophane recombinant human

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C300596 Netherlands   Start Trial 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
0705275 41/2005 Austria   Start Trial PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
2107069 31/2013 Austria   Start Trial PRODUCT NAME: INSULIN DEGLUDEC UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/807/001, EU/1/12/807/004, EU/1/12/807/005, EU/1/12/807/007, EU/1/12/807/008, EU/1/12/807/009, EU/1/12/807/012, EU/1/12/807/013, EU/1/12/807/015 (MITTEILUNG) 20130123
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0368187 0091020-8 0090020-9 Sweden   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
2107069 92226 Luxembourg   Start Trial PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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