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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Merck
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Farmers Insurance
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Generated: December 12, 2017

DrugPatentWatch Database Preview

NOVOLOG Drug Profile

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

Novolog is a drug marketed by Novo Nordisk Inc and is included in three NDAs. There are sixteen patents protecting this drug.

This drug has twenty-nine patent family members in twenty countries and forty-two supplementary protection certificates in twelve countries.

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

Summary for NOVOLOG

US Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: 3
Clinical Trials: 48
Drug Prices:see details
DailyMed Link:NOVOLOG at DailyMed
Drug patent expirations by year for NOVOLOG

Pharmacology for NOVOLOG

Ingredient-typeInsulin
Drug ClassInsulin Analog

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 MIX 70/30 PENFILLinsulin aspart protamine recombinant; insulin aspart recombinantINJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG PENFILLinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOGinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-001Jun 7, 2000RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG INNOLETinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG MIX 70/30 FLEXPENinsulin aspart protamine recombinant; insulin aspart recombinantINJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXPENinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG MIX 50/50insulin aspart protamine recombinant; insulin aspart recombinantINJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncNOVOLOG FLEXTOUCHinsulin aspart recombinantINJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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International Patent Family for Tradename: NOVOLOG

Country Document Number Estimated Expiration
European Patent Office0921812► Subscribe
Australia3253697► Subscribe
Hungary9904031► Subscribe
China1222083► Subscribe
Denmark0921812► Subscribe
China1120019► Subscribe
Canada2258097► Subscribe
Japan2000513344► Subscribe
Germany69708121► Subscribe
Australia720484► 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

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:

US Department of Justice
Medtronic
Fuji
Federal Trade Commission
Johnson and Johnson
Colorcon
Merck
AstraZeneca
Accenture
Boehringer Ingelheim

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