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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
Drug Prices:see low prices

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*PEDDec 19, 2017Y
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesRE41956Jan 21, 2021Y
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008DISCNNo5,866,538*PEDDec 20, 2017Y
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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 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 20025,618,913*PED<disabled>
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 20025,834,422<disabled>
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 20015,547,930<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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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 aspart protamine recombinant; insulin aspart recombinant

Country Document Number Estimated Expiration
Japan3270761<disabled in preview>
Hungary228094<disabled in preview>
Israel127366<disabled in preview>
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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 ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90029-5Sweden<disabled>PRODUCT NAME: INSULIN DEGLUDEK; REG. NO/DATE: EU/1/12/807/001 20130121
13/34Ireland<disabled>PRODUCT: 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
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
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