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Last Updated: November 14, 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 patent protection?

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-five 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

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

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

See all insulin aspart clinical trials

Recent Litigation for insulin aspart

Identify potential future generic entrants

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

See all insulin aspart litigation

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 RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 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 RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo Nordisk Inc NOVOLOG MIX 70/30 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-001 Nov 1, 2001 RX Yes Yes   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 aspart

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
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
2107069 1390029-5 Sweden   Start Trial PRODUCT NAME: INSULIN DEGLUDEK
2597103 2017/015 Ireland   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Express Scripts
Moodys
Harvard Business School
Johnson and Johnson

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