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

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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.

This ingredient 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. Six suppliers are listed for this compound.

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

Tradenames:4
Patents:1
Applicants:2
NDAs:3
Drug Master File Entries: see list38
Suppliers / Packaging: see list6
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: insulin recombinant human; insulin susp isophane recombinant human

Ingredient-typeInsulin
Drug ClassInsulin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMULIN 50/50
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION020100-001Apr 29, 1992DISCNNo► subscribe► subscribe
Lilly
HUMULIN 70/30 PEN
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION019717-002Aug 6, 1998OTCYes7,291,132► subscribeY ► subscribe
Lilly
HUMULIN 70/30
insulin recombinant human; insulin susp isophane recombinant human
INJECTABLE;INJECTION019717-001Apr 25, 1989OTCYes7,291,132► 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
Norway20061150► subscribe
South Africa200601093► subscribe
China100531813► 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
213Luxembourg► subscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
91022-0Sweden► subscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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
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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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