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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Fuji
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Novartis
Queensland Health
Medtronic
Baxter
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Generated: December 12, 2017

DrugPatentWatch Database Preview

NOVOLOG FLEXPEN Drug Profile

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Which patents cover Novolog Flexpen, and when can generic versions of Novolog Flexpen launch?

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 one hundred and four patent family members in twenty-two countries and forty-two supplementary protection certificates in twelve countries.

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

Summary for NOVOLOG FLEXPEN

Drug patent expirations by year for NOVOLOG FLEXPEN

Pharmacology for NOVOLOG FLEXPEN

Ingredient-typeInsulin
Drug ClassInsulin Analog

Medical Subject Heading (MeSH) Categories for NOVOLOG FLEXPEN

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► 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
Germany69900026► Subscribe
Australia778714► Subscribe
Canada2258097► Subscribe
Germany60043595► Subscribe
Japan4361236► Subscribe
Hungary9904031► Subscribe
Australia3253697► Subscribe
Australia6820500► Subscribe
Poland196742► Subscribe
Brazil9906857► 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
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
60026Netherlands► SubscribePRODUCT 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
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
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
13/34Ireland► SubscribePRODUCT: 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
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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Serving leading biopharmaceutical companies globally:

Julphar
Baxter
UBS
Johnson and Johnson
Citi
US Army
Cipla
Merck
Boehringer Ingelheim
Federal Trade Commission

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