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Last Updated: January 24, 2020

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Insulin lispro - Generic Drug Details

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What are the generic drug sources for insulin lispro and what is the scope of freedom to operate?

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

Insulin lispro has two hundred and twenty patent family members in twenty-eight countries.

There are forty drug master file entries for insulin lispro. Two suppliers are listed for this compound.

Drug Prices for insulin lispro

See drug prices for insulin lispro

Recent Clinical Trials for insulin lispro

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

SponsorPhase
Institut de Recherches Cliniques de MontrealPhase 2
Rigshospitalet, DenmarkPhase 4
Zealand PharmaPhase 2/Phase 3

See all insulin lispro clinical trials

Recent Litigation for insulin lispro

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MYLAN N v.2017-10-24
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

See all insulin lispro litigation

PTAB Litigation
PetitionerDate
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29
Mylan Pharmaceuticals Inc2018-09-10

See all insulin lispro litigation

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
Lilly HUMALOG MIX 50/50 PEN insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021018-003 Dec 22, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Lilly HUMALOG MIX 50/50 insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021018-001 Dec 22, 1999 RX Yes Yes   Start Trial   Start Trial   Start Trial
Lilly HUMALOG KWIKPEN insulin lispro recombinant INJECTABLE;INJECTION 020563-003 Sep 6, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   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 lispro

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 1390036-0 Sweden   Start Trial PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
2107069 122013000061 Germany   Start Trial 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
2107069 92226 Luxembourg   Start Trial PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
0792290 PA2004005,C0792290 Lithuania   Start Trial 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
0705275 41/2005 Austria   Start Trial 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
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2107069 13C0035 France   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Dow
AstraZeneca

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