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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
McKesson
Baxter
Deloitte
Argus Health
Daiichi Sankyo
Fish and Richardson
Johnson and Johnson
Harvard Business School

Generated: July 17, 2018

DrugPatentWatch Database Preview

Insulin susp isophane recombinant human - Generic Drug Details

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What are the generic drug sources for insulin susp isophane recombinant human and what is the scope of insulin susp isophane recombinant human patent protection?

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

Insulin susp isophane recombinant human has twelve patent family members in nine countries.

There are thirty-nine drug master file entries for insulin susp isophane recombinant human. Five suppliers are listed for this compound.
Summary for insulin susp isophane recombinant human
International Patents:12
US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 39
Suppliers / Packagers: 5
Clinical Trials: 7
DailyMed Link:insulin susp isophane recombinant human at DailyMed

US Patents and Regulatory Information for insulin susp isophane recombinant human

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc NOVOLIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 019959-001 Jul 1, 1991 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly HUMULIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 018781-001 Oct 28, 1982 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,427,275 Medication dispensing apparatus with triple screw threads for mechanical advantage ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for insulin susp isophane recombinant human

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
60026 Netherlands ➤ Sign Up PRODUCT 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
00698 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
91022-0 Sweden ➤ Sign Up PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Covington
QuintilesIMS
Citi
Baxter
Healthtrust
Cerilliant
Chinese Patent Office
Farmers Insurance

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