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Generated: April 24, 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 thirteen patent family members in nine countries.

There are forty drug master file entries for insulin human. Two suppliers are listed for this compound.

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 04C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
2107069 C300597 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
0792290 PA2004005 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR
2209800 C02209800/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
2209800 C300698 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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