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Generated: May 26, 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 freedom to operate?

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

Insulin aspart has one hundred and twenty-nine patent family members in twenty-one 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

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 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 PENFILL insulin aspart protamine recombinant; insulin aspart recombinant INJECTABLE;SUBCUTANEOUS 021172-002 Nov 1, 2001 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751-002 Sep 29, 2017 RX Yes Yes ➤ 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 RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 2013/34 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
0705275 32/2000 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
2107069 2013/034 Ireland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
0214826 C990042 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
2107069 92226 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
2498802 300883 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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