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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Fuji
Moodys
Healthtrust
Johnson and Johnson
Chinese Patent Office
Teva
Express Scripts
Harvard Business School

Generated: December 10, 2017

DrugPatentWatch Database Preview

HUMULIN N Drug Profile

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Which patents cover Humulin N, and what generic alternatives 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 and forty-two supplementary protection certificates in twelve 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 HUMULIN N

US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Clinical Trials: 20
Drug Prices:see details
DailyMed Link:HUMULIN N at DailyMed
Drug patent expirations by year for HUMULIN N

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
LillyHUMULIN Ninsulin susp isophane recombinant humanINJECTABLE;INJECTION018781-001Oct 28, 1982OTCYesYes► Subscribe► Subscribe► 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
South Africa200601093► Subscribe
Japan4718462► Subscribe
Japan2007502146► Subscribe
China1835774► Subscribe
China100531813► Subscribe
World Intellectual Property Organization (WIPO)2005018721► Subscribe
European Patent Office1656170► Subscribe
Norway20061150► Subscribe
Canada2530263► Subscribe
South Korea20060061822► 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
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
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
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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Serving leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
Julphar
Farmers Insurance
Cerilliant
Covington
McKesson
Fuji
AstraZeneca
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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