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Serving leading biopharmaceutical companies globally:

Teva
US Department of Justice
UBS
Queensland Health
Citi
Baxter
Healthtrust
Fish and Richardson
Mallinckrodt
Dow

Generated: October 21, 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 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 Tradename: NOVOLOG

US Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: see list3
Clinical Trials: see list47
Drug Prices:see details
DailyMed Link:NOVOLOG at DailyMed

Pharmacology for Tradename: NOVOLOG

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-001Jun 7, 2000RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: NOVOLOG

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-001Jun 7, 2000► Subscribe► Subscribe
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International Patent Family for Tradename: NOVOLOG

Country Document Number Estimated Expiration
Hungary9904031► Subscribe
South Korea20000022031► Subscribe
World Intellectual Property Organization (WIPO)9748414► Subscribe
Portugal921812► Subscribe
Canada2258097► Subscribe
European Patent Office0921812► Subscribe
Norway985981► Subscribe
China1120019► Subscribe
Brazil9709845► Subscribe
Czech Republic297937► 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
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
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
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2013000062Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
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
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Queensland Health
Express Scripts
Cantor Fitzgerald
Moodys
Boehringer Ingelheim
Cipla
Healthtrust
Federal Trade Commission
Harvard Business School

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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