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Serving leading biopharmaceutical companies globally:

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Generated: December 12, 2017

DrugPatentWatch Database Preview

Insulin recombinant human; insulin susp isophane recombinant human - Generic Drug Details

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What are the generic drug sources for insulin recombinant human; insulin susp isophane recombinant human and what is the scope of insulin recombinant human; insulin susp isophane recombinant human freedom to operate?

Insulin recombinant human; insulin susp isophane recombinant human
is the generic ingredient in four branded drugs marketed by Lilly and Novo Nordisk Inc, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin recombinant human; insulin susp isophane recombinant human has twelve patent family members in nine countries and forty-two supplementary protection certificates in twelve countries.

There are thirty-eight drug master file entries for insulin recombinant human; insulin susp isophane recombinant human. Five suppliers are listed for this compound.

Summary for insulin recombinant human; insulin susp isophane recombinant human

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 70/30insulin recombinant human; insulin susp isophane recombinant humanINJECTABLE;INJECTION019717-001Apr 25, 1989OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyHUMULIN 70/30 PENinsulin recombinant human; insulin susp isophane recombinant humanINJECTABLE;INJECTION019717-002Aug 6, 1998OTCYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyHUMULIN 50/50insulin recombinant human; insulin susp isophane recombinant humanINJECTABLE;INJECTION020100-001Apr 29, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Novo Nordisk IncNOVOLIN 70/30insulin recombinant human; insulin susp isophane recombinant humanINJECTABLE;INJECTION019991-001Jun 25, 1991OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin recombinant human; insulin susp isophane recombinant human

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 Ingredient: insulin recombinant human; insulin susp isophane recombinant human

Country Document Number Estimated Expiration
European Patent Office1656170► Subscribe
Canada2530263► Subscribe
South Korea20060061822► Subscribe
China1835774► Subscribe
Australia2004266131► Subscribe
World Intellectual Property Organization (WIPO)2005018721► Subscribe
Japan4718462► Subscribe
Japan2007502146► Subscribe
Norway20061150► Subscribe
South Africa200601093► 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: INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
13/34Ireland► SubscribePRODUCT: 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
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
Cerilliant
Medtronic
Fish and Richardson
Covington
US Department of Justice
Queensland Health
Daiichi Sankyo
Argus Health

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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