You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
McKinsey
Merck
Express Scripts
Baxter

Last Updated: February 19, 2020

DrugPatentWatch Database Preview

Insulin lispro - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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 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

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
Beta Bionics, Inc.Phase 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
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
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 KWIKPEN insulin lispro recombinant INJECTABLE;INJECTION 020563-003 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
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 1390036-0 Sweden   Start Trial PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
0885961 C00885961/01 Switzerland   Start Trial PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
2498802 CR 2017 00020 Denmark   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Colorcon
Dow
Boehringer Ingelheim
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.