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Last Updated: April 6, 2020

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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 freedom to operate?

Insulin lispro is the generic ingredient in twelve 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

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Recent Clinical Trials for INSULIN LISPRO

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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
2019-05-02
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29

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
Eli Lilly And Co HUMALOG KWIKPEN insulin lispro recombinant SOLUTION;SUBCUTANEOUS 205747-001 May 26, 2015 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
Lilly HUMALOG MIX 50/50 KWIKPEN insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021018-002 Sep 6, 2007 RX Yes Yes   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
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2597103 CA 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
0885961 C00885961/01 Switzerland   Start Trial PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Mallinckrodt
McKesson
Medtronic
Harvard Business School

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