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NOVOLOG INNOLET Drug Profile

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Which patents cover Novolog Innolet, and what substitute generic drugs are available?

Novolog Innolet is a drug marketed by Novo Nordisk Inc and is included in one NDA. 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
Clinical Trials: see list14
Drug Prices:see details
DailyMed Link:NOVOLOG INNOLET at DailyMed

Pharmacology for Tradename: NOVOLOG INNOLET

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNo5,866,538*PED► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNoRE41956*PED► Subscribe ► Subscribe
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Expired Patents for Tradename: NOVOLOG INNOLET

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
Russian Federation2254878► Subscribe
Spain2338792► Subscribe
Canada2383078► Subscribe
Russian Federation2182015► Subscribe
World Intellectual Property Organization (WIPO)0119434► 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
13/034Ireland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; NATL. REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121; FIRST REGISTRATION: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 20130121
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
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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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