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HUMULIN N Drug Profile

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Which patents cover Humulin N, and what substitute generic drugs are available?

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

This drug has twelve patent family members in nine countries.

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

Summary for Tradename: HUMULIN N

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list14
Drug Prices:see details
DailyMed Link:HUMULIN N at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMULIN N
insulin susp isophane recombinant human
INJECTABLE;INJECTION018781-001Oct 28, 1982OTCYesYes7,291,132► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: HUMULIN N

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
7,427,275Medication dispensing apparatus with triple screw threads for mechanical advantage► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: HUMULIN N

Country Document Number Estimated Expiration
China1835774► Subscribe
Norway20061150► Subscribe
Canada2530263► Subscribe
Japan4718462► Subscribe
European Patent Office1656170► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: HUMULIN N

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
00596Netherlands► SubscribePRODUCT 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
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
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