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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Express Scripts
Teva
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Baxter
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Argus Health
Novartis
Chinese Patent Office
Julphar

Generated: June 27, 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 are two patents 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.

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

Summary for Generic Name: insulin recombinant human; insulin susp isophane recombinant human

Tradenames:4
Patents:2
Applicants:2
NDAs:3
Drug Master File Entries: see list38
Suppliers / Packagers: see list4
Clinical Trials: see list11,441
Drug Prices:see low prices
DailyMed Link:insulin recombinant human; insulin susp isophane recombinant human at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMULIN 70/30
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION019717-001Apr 25, 1989OTCYesYes7,291,132► SubscribeY ► Subscribe
Lilly
HUMULIN 50/50
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION020100-001Apr 29, 1992DISCNNoNo► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLIN 70/30
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION019991-001Jun 25, 1991OTCYesYes► Subscribe► Subscribe
Lilly
HUMULIN 70/30 PEN
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION019717-002Aug 6, 1998OTCYesYes7,291,132► SubscribeY ► 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
Canada2530263► Subscribe
China100531813► Subscribe
Japan4718462► Subscribe
Norway20061150► Subscribe
Australia2004266131► 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
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
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Colorcon
Dow
Merck
Cerilliant
Healthtrust
Deloitte
McKesson
Baxter

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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