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Last Updated: April 1, 2020

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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-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for insulin aspart

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Recent Clinical Trials for insulin aspart

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

SponsorPhase
Yale UniversityEarly Phase 1
McGill UniversityN/A
Juvenile Diabetes Research FoundationN/A

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Recent Litigation for insulin aspart

Identify potential future generic entrants

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 RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial   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 FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX 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 aspart

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498802 C02498802/01 Switzerland   Start Trial PRODUCT NAME: INSULINUM GLARGINUM + LIXISENATIDUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 66283 05.10.2017
2107069 92213 Luxembourg   Start Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
0705275 C300021 Netherlands   Start Trial PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Dow
Express Scripts
Johnson and Johnson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.