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NOVOLOG INNOLET Drug Profile

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Novolog Innolet is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug.

This drug has fifty-nine patent family members in twenty-one countries.

The generic ingredient in NOVOLOG INNOLET is insulin aspart recombinant. There are thirty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin aspart recombinant profile page.

Summary for Tradename: NOVOLOG INNOLET

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Drug Prices: :see details

Pharmacology for Tradename: NOVOLOG INNOLET

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 INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNo5,866,538*PED► subscribeY► subscribe
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoRE41956*PED► subscribe ► subscribe
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Expired Patents for Tradename: NOVOLOG INNOLET

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 20045,618,913*PED► subscribe
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Non-Orange Book Patents for Tradename: NOVOLOG INNOLET

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
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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 Tradename: NOVOLOG INNOLET

Country Document Number Estimated Expiration
Japan2009235075► subscribe
World Intellectual Property Organization (WIPO)0119434► subscribe
Denmark1250167► 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: NOVOLOG INNOLET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020France► subscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C/GB05/024United Kingdom► subscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
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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