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Insulin aspart protamine recombinant; insulin aspart recombinant - Generic Drug Details

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Insulin aspart protamine recombinant; insulin aspart recombinant is the generic ingredient in four branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-eight patent family members in twenty-two countries.

There are thirty-eight drug master file entries for insulin aspart protamine recombinant; insulin aspart recombinant. Two suppliers are listed for this compound.

Summary for Generic Name: insulin aspart protamine recombinant; insulin aspart recombinant

Tradenames:4
Patents:5
Applicants:1
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packaging: see list2

Pharmacology for Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Clinical Trials for: insulin aspart protamine recombinant; insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 2001RXYes5,866,538*PED<disabled>Y<disabled>
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001DISCNNo5,866,538*PED<disabled>Y<disabled>
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesRE41956<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 20015,618,913*PED<disabled>
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 20085,547,930<disabled>
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 20085,618,913*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

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
6,582,404 Dose setting limiter<disabled in preview>
6,235,004 Injection syringe<disabled in preview>
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International Patent Family for Ingredient: insulin aspart protamine recombinant; insulin aspart recombinant

Country Document Number Estimated Expiration
Russian Federation2214286<disabled in preview>
Greece3035145<disabled in preview>
Japan5634068<disabled in preview>
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Supplementary Protection Certificates for Tradename: INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00597Netherlands<disabled>PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
60026Netherlands<disabled>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
/2005Austria<disabled>PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
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