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Boehringer Ingelheim
Express Scripts
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Johnson and Johnson
Cipla
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US Department of Justice
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Generated: January 24, 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 insulin aspart patent protection?

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

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

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

Pharmacology for insulin aspart
Drug ClassInsulin Analog
Synonyms for insulin aspart
(AspB28)-human insulin
28(sup B)-L-Aspartic acid-insulin (human)
AM013058
Aspart
Aspart insulin
AspB28-insulin (human)
B28-Asp-insulin
D0I3LE
INA-X 14
Insulin aspart [USAN]
Insulin X14
Insulin-aspart
LS-185932
NovoLog
Novolog mix 70/30
NovoRapid

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 MIX 70/30 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-003 Nov 1, 2001 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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 MIX 70/30 FLEXPEN insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-004 May 3, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes ➤ 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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Supplementary Protection Certificates for insulin aspart

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90036-0 Sweden ➤ Sign Up PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Deloitte
Daiichi Sankyo
Cipla
McKinsey
Dow
Teva
Covington
Cantor Fitzgerald

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