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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Department of Justice
Citi
Daiichi Sankyo
Moodys
Colorcon
Baxter
UBS
Chubb

Generated: May 20, 2018

DrugPatentWatch Database Preview

Insulin human - Generic Drug Details

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

Insulin human
is the generic ingredient in two branded drugs marketed by Lilly and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin human has twelve patent family members in nine countries.

There are thirty-nine drug master file entries for insulin human. Three suppliers are listed for this compound.
Summary for insulin human
International Patents:12
US Patents:1
Tradenames:2
Applicants:1
NDAs:1
Drug Master File Entries: 39
Suppliers / Packagers: 3
Clinical Trials: 4,097
Formulation / Manufacturing:see details
DailyMed Link:insulin human at DailyMed
Pharmacology for insulin human
Ingredient-typeInsulin
Drug ClassInsulin

US Patents and Regulatory Information for insulin human

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HUMULIN R KWIKPEN insulin human SOLUTION;SUBCUTANEOUS 018780-002 Dec 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly HUMULIN R insulin human SOLUTION;SUBCUTANEOUS 018780-004 Mar 31, 1994 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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Non-Orange Book US Patents for insulin human

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,427,275 Medication dispensing apparatus with triple screw threads for mechanical advantage ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for insulin human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2/2005 Austria ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE
00698 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
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
C0085 France ➤ Sign Up PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Fuji
US Department of Justice
Queensland Health
Chinese Patent Office
US Army
Harvard Business School
QuintilesIMS
Moodys

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