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Serving leading biopharmaceutical companies globally:

McKesson
Federal Trade Commission
Cipla
Moodys
McKinsey
Accenture
Dow
Farmers Insurance
Citi
Cerilliant

Generated: October 22, 2017

DrugPatentWatch Database Preview

Novo Nordisk Company Profile

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What is the competitive landscape for NOVO NORDISK, and what generic alternatives to NOVO NORDISK drugs are available?

NOVO NORDISK has forty-one approved drugs.

There are thirty US patents protecting NOVO NORDISK drugs on NOVO NORDISK drugs in the past three years.

There are four hundred and thirty-eight patent family members on NOVO NORDISK drugs in thirty-four countries and one hundred and eleven supplementary protection certificates in fifteen countries.

Summary for Applicant: Novo Nordisk

International Patents:438
US Patents:30
Tradenames:50
Ingredients:31
NDAs:41
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
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-008Mar 1, 2010BXRXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
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
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-007Mar 10, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Novo Nordisk

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013► Subscribe► Subscribe
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008► Subscribe► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-001Jun 20, 2000► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-001Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-003Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-008Mar 1, 2010► Subscribe► Subscribe
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Paragraph IV activity for NOVO NORDISK drugs

Drugname Dosage Strength Tradename Submissiondate
liraglutide
Injection18 mg/3 mL prefilled syringe
VICTOZA
12/12/2016
estradiol
Vaginal Tablets10 mcg
VAGIFEM
1/2/2013
repaglinide and metformin hydrochloride
Tablets1 mg/500 mg and 2 mg/500 mg
PRANDIMET
4/9/2009

Non-Orange Book Patents for Novo Nordisk

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
8,097,698Derivatives of GLP-1 analogs► Subscribe
6,582,404 Dose setting limiter► Subscribe
9,616,180Automatic injection device with a top release mechanism► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
6,011,007 Acylated insulin► Subscribe
8,096,978Automatic injection device with a top release mechanism► Subscribe
6,384,016 Stabilized aqueous peptide solutions► Subscribe
8,828,923Insulin derivatives► Subscribe
7,226,990Extendin derivatives► Subscribe
6,869,930 Acylated insulin► 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 Novo Nordisk Drugs

Country Document Number Estimated Expiration
HungaryE030383► Subscribe
Japan2000060556► Subscribe
World Intellectual Property Organization (WIPO)03002136► Subscribe
European Patent Office1003581► Subscribe
Australia6820500► Subscribe
Netherlands300422► Subscribe
European Patent Office1351732► Subscribe
Japan2002508162► Subscribe
Russian Federation2421238► Subscribe
European Patent Office2275439► 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 Novo Nordisk Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
496Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
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
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
C/GB04/036United Kingdom► SubscribePRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
McKinsey
Deloitte
Queensland Health
Fuji
Citi
Covington
Express Scripts
Chinese Patent Office
US Department of Justice

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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