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Generated: November 18, 2018

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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 freedom to operate?

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.

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

Pharmacology for insulin aspart
Ingredient-typeInsulin
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 50/50 insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021810-001 Aug 26, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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 ➤ 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 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 FLEXPEN insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 020986-003 Jan 19, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc FIASP insulin aspart SOLUTION;IV (INFUSION), SUBCUTANEOUS 208751-001 Sep 29, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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
/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
213 Luxembourg ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
/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
0880 Netherlands ➤ Sign Up PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
90036-0 Sweden ➤ Sign Up PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
13/34 Ireland ➤ Sign Up PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Chubb
Teva
Cantor Fitzgerald
Chinese Patent Office
Medtronic
Dow
Cipla
AstraZeneca

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