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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Queensland Health
Baxter
Chubb
Chinese Patent Office
Cantor Fitzgerald
Teva
Cipla
Healthtrust

Generated: October 23, 2017

DrugPatentWatch Database Preview

Novo Nordisk Inc Company Profile

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

NOVO NORDISK INC has forty approved drugs.

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

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

Summary for Applicant: Novo Nordisk Inc

International Patents:438
US Patents:30
Tradenames:49
Ingredients:30
NDAs:40
Drug Master File Entries: (click here to view)2
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
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015RXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► 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
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010RXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
INSULATARD NPH HUMAN
insulin susp isophane semisynthetic purified human
INJECTABLE;INJECTION019449-001May 30, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
FIASP FLEXTOUCH
insulin aspart recombinant
SOLUTION;SUBCUTANEOUS208751-002Sep 29, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Novo Nordisk Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 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
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-004Oct 1, 2004► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-005Oct 1, 2004► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-002Jun 20, 2000► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-008Mar 1, 2010► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 PENFILL
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-002Nov 1, 2001► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION021148-002Jun 20, 2000► Subscribe► Subscribe
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Paragraph IV activity for NOVO NORDISK INC 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 Inc

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

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006076921► Subscribe
Israel126463► Subscribe
Japan4060583► Subscribe
Canada2252535► Subscribe
Australia2156702► Subscribe
South Africa200703706► Subscribe
European Patent Office1132404► Subscribe
World Intellectual Property Organization (WIPO)9938554► Subscribe
Germany69942306► Subscribe
Norway340925► 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 Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
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
0130013 00086Estonia► SubscribePRODUCT NAME: DEGLUDEKINSULIIN;REG NO/DATE: (2013) 637 (LOPLIK) COR. 21.01.2013
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2013 00030Denmark► Subscribe
/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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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:

Chinese Patent Office
Medtronic
Federal Trade Commission
McKesson
Johnson and Johnson
Baxter
Cerilliant
Queensland Health
Moodys
Boehringer Ingelheim

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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