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Generated: January 18, 2019

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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 forty drug master file entries for insulin human. Two 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: 40
Suppliers / Packagers: 2
Clinical Trials: 4,308
Formulation / Manufacturing:see details
DailyMed Link:insulin human at DailyMed
Pharmacology for insulin human
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 insulin human SOLUTION;SUBCUTANEOUS 018780-004 Mar 31, 1994 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly HUMULIN R KWIKPEN insulin human SOLUTION;SUBCUTANEOUS 018780-002 Dec 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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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Supplementary Protection Certificates for insulin human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90067-4 Sweden ➤ Sign Up PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
13/34 Ireland ➤ Sign Up PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
34/2000 Austria ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN
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
2017000039 Germany ➤ Sign Up 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
91020-8 0090020-9 Sweden ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
90029-5 Sweden ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEK
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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