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Insulin aspart recombinant - Generic Drug Details

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Insulin aspart recombinant is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and eighty-four patent family members in twenty-two countries.

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

Summary for Generic Name: insulin aspart recombinant

Tradenames:5
Patents:13
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packaging: see list4
Drug Prices:see low prices

Pharmacology for Ingredient: insulin aspart recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYes5,866,538*PED► subscribeY► subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYes8,684,969► subscribeY ► subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYes8,672,898► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 20005,626,566*PED► subscribe
Novo Nordisk Inc
NOVOLOG
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-001Jun 7, 20005,618,913*PED► subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 20015,618,913*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► subscribe
8,096,978Automatic injection device with a top release mechanism► subscribe
8,357,120Injection device with torsion spring and rotatable display► 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 aspart recombinant

Country Document Number Estimated Expiration
Denmark0921812► subscribe
BrazilPI0919925► subscribe
Canada2676810► 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 ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005Austria► subscribePRODUCT 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
C0035France► subscribePRODUCT NAME: INSULINE DEGLUTEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
2004005Lithuania► subscribePRODUCT NAME: INSULIN DETEMIR
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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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