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Insulin aspart protamine recombinant; insulin aspart recombinantis the generic ingredient in four branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Insulin aspart protamine recombinant; insulin aspart recombinant has one hundred patent family members in twenty-two countries.
There are forty drug master file entries for insulin aspart protamine recombinant; insulin aspart recombinant. Four suppliers are listed for this compound.
Summary for insulin aspart protamine recombinant; insulin aspart recombinant
|Drug Master File Entries:||40|
|Suppliers / Packagers:||4|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for insulin aspart protamine recombinant; insulin aspart recombinant|
|DailyMed Link:||insulin aspart protamine recombinant; insulin aspart recombinant at DailyMed|
Recent Clinical Trials for insulin aspart protamine recombinant; insulin aspart recombinant
Identify potential brand extensions & 505(b)(2) entrants
|Vancouver General Hospital||Phase 4|
|Novo Nordisk A/S||Phase 4|
Recent Litigation for insulin aspart protamine recombinant; insulin aspart recombinant
Identify potential future generic entrants
District Court Litigation
|SANOFI-AVENTIS U.S. LLC v. MERCK SHARP & DOHME CORP.||2017-08-08|
|Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.||2017-03-03|
|SMITH v. NOVO NORDISK INC.||2016-08-08|
Pharmacology for insulin aspart protamine recombinant; insulin aspart recombinant
|Drug Class||Insulin Analog |
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2107069||C 2013 022||Romania||Start Trial||PRODUCT NAME: COMBINATIE DE INSULINA DEGLUDEC SI INSULINA ASPART IN TOATEFORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001,EU/1/12/806/004,EU/1/12/806/005,EU/1/12/806/007,00; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, 00; DATE OF FIRST AUTHORISATION IN EEA: 20130121|
|2498802||2017030||Norway||Start Trial||PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125|
|0705275||SPC/GB00/027||United Kingdom||Start Trial||PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801|
|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||SPC/GB05/024||United Kingdom||Start Trial||PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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