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Generated: October 21, 2018

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INSULIN ASPART RECOMBINANT - Generic Drug Details

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What are the generic drug sources for insulin aspart recombinant and what is the scope of insulin aspart recombinant freedom to operate?

Insulin aspart recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for insulin aspart recombinant. Three suppliers are listed for this compound.

Pharmacology for INSULIN ASPART RECOMBINANT
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for INSULIN ASPART RECOMBINANT

US Patents and Regulatory Information for INSULIN ASPART 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 NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG INNOLET insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-004 Apr 23, 2004 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No ➤ 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 ASPART RECOMBINANT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc NOVOLOG insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-001 Jun 7, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG INNOLET insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-004 Apr 23, 2004 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG PENFILL insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-002 Jun 7, 2000 ➤ Sign Up ➤ Sign Up
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for INSULIN ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0044 Belgium ➤ Sign Up PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
C0023 France ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
60026 Netherlands ➤ Sign Up PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
90036-0 Sweden ➤ Sign Up PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
/2005 Austria ➤ Sign Up 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
2013000061 Germany ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Chinese Patent Office
Colorcon
Teva
Fuji
Cantor Fitzgerald
AstraZeneca
Accenture
Daiichi Sankyo

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