Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKesson
Merck
McKinsey
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Insulin lispro - Generic Drug Details

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« 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 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
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
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16
Sanofi-Aventis U.S. LLC v. Eli Lilly and Company2014-01-30

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
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
Sanofi-aventis Us ADMELOG insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-001 Dec 11, 2017 RX Yes No   Start Trial   Start Trial   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
2498802 122017000039 Germany   Start Trial PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
0885961 SPC/GB05/024 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
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

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Mallinckrodt
Dow
Express Scripts
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.