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Last Updated: February 20, 2020

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INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - Generic Drug Details

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

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 twenty patent family members in sixteen countries.

There are forty drug master file entries for insulin recombinant human; insulin susp isophane recombinant human. Two 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
Profil Institut für Stoffwechselforschung GmbHPhase 1
Julphar Gulf Pharmaceutical IndustriesPhase 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
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
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 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
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
>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 2013/34 Ireland   Start Trial PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
2597103 CR 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
0368187 C300019 Netherlands   Start Trial PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
0885961 SZ 2/2005 Austria   Start Trial PRODUCT NAME: INSULIN GLULISINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Merck
Baxter
Mallinckrodt
Dow

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