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Last Updated: December 5, 2019

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INSULIN ASPART - Generic Drug Details

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

Insulin aspart is the generic ingredient in thirteen branded drugs marketed by Novo and Novo Nordisk Inc, and is included in five NDAs. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart has one hundred and sixty-five patent family members in twenty-one countries.

There are forty drug master file entries for insulin aspart. One supplier is listed for this compound.

Recent Clinical Trials for INSULIN ASPART

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SponsorPhase
Institut de Recherches Cliniques de MontrealPhase 2
Nantes University HospitalPhase 4
University of Colorado, DenverPhase 4

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Recent Litigation for INSULIN ASPART

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District Court Litigation
Case NameDate
SMITH v. NOVO NORDISK INC.2016-08-08

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Pharmacology for INSULIN ASPART
Drug ClassInsulin Analog

US Patents and Regulatory Information for INSULIN ASPART

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 FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG FLEXTOUCH insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-005 Oct 31, 2013 DISCN Yes No   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 ASPART

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 PA2017020,C2498802 Lithuania   Start Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSISENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2597103 CA 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 0091020-8 0090020-9 Sweden   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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