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NOVOLOG FLEXPEN Drug Profile

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

Novolog Flexpen is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in NOVOLOG FLEXPEN 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 FLEXPEN

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Clinical Trials: see list18
Drug Prices:see details
DailyMed Link:NOVOLOG FLEXPEN at DailyMed

Pharmacology for Tradename: NOVOLOG FLEXPEN

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 FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes9,265,893► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYesRE43834► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYesRE41956► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes6,004,297► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes5,866,538*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: NOVOLOG FLEXPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 Tradename: NOVOLOG FLEXPEN

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
6,235,004 Injection syringe► Subscribe
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 FLEXPEN

Country Document Number Estimated Expiration
Australia6820500► Subscribe
Japan3270761► Subscribe
Poland341395► Subscribe
China1243578► Subscribe
Hungary222513► 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 FLEXPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
00597Netherlands► SubscribePRODUCT 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
/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
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 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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