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Generated: November 12, 2018

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Insulin lispro - Generic Drug Details

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What are the generic sources for insulin lispro and what is the scope of insulin lispro patent protection?

Insulin lispro is the generic ingredient in eleven branded drugs marketed by Sanofi-aventis Us, Lilly, and Eli Lilly And Co, 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 lispro. One supplier is listed for this compound.

Pharmacology for insulin lispro
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for insulin lispro

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;IV (INFUSION), SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;IV (INFUSION), SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;IV (INFUSION), SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;IV (INFUSION), SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly HUMALOG MIX 50/50 insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021018-001 Dec 22, 1999 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eli Lilly And Co HUMALOG KWIKPEN insulin lispro recombinant SOLUTION;SUBCUTANEOUS 205747-001 May 26, 2015 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 lispro

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009 France ➤ Sign Up PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
C/GB00/022 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
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
C0023 France ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
C0044 Belgium ➤ Sign Up PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
C/GB00/027 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Farmers Insurance
Covington
Baxter
Dow
Deloitte
Federal Trade Commission
Fish and Richardson

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