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Last Updated: April 5, 2020

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HUMULIN N Drug Profile


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Which patents cover Humulin N, and when can generic versions of Humulin N launch?

Humulin N is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in HUMULIN N is insulin susp isophane recombinant human. There are forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin susp isophane recombinant human profile page.

US ANDA Litigation and Generic Entry Outlook for Humulin N

Annual sales in 2017 were $737mm indicating the motivation for generic entry (peak sales were $3.9bn in 2015).

Indicators of Generic Entry

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Drug patent expirations by year for HUMULIN N
Drug Prices for HUMULIN N

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Drug Sales Revenue Trends for HUMULIN N

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Recent Clinical Trials for HUMULIN N

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SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 1
International Diabetes Center at Park NicolletPhase 2
Juvenile Diabetes Research FoundationPhase 2

See all HUMULIN N clinical trials

US Patents and Regulatory Information for HUMULIN N

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HUMULIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 018781-001 Oct 28, 1982 OTC 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 HUMULIN N

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
0368187 SPC/GB00/022 United Kingdom   Start Trial 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
2498802 C201730022 Spain   Start Trial PRODUCT NAME: SULIQUA-INSULINA GLARGINA/ LIXISENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1157; DATE OF AUTHORISATION: 20170111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1157; DATE OF FIRST AUTHORISATION IN EEA: 20170111
2107069 1390029-5 Sweden   Start Trial PRODUCT NAME: INSULIN DEGLUDEK
2498802 2017030 Norway   Start Trial PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
2107069 SPC/GB13/037 United Kingdom   Start Trial PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123
2209800 132014902311502 Italy   Start Trial PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
AstraZeneca
Express Scripts
Medtronic
Dow

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