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Serving 500+ biopharmaceutical companies globally:

Chubb
Cerilliant
Moodys
Cipla
Colorcon
Healthtrust
Fish and Richardson
Mallinckrodt
Federal Trade Commission
Dow

Generated: August 19, 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 approved drugs.

There are twenty-nine US patents protecting NOVO NORDISK drugs on NOVO NORDISK drugs in the past three years.

There are four hundred and thirty-six patent family members on NOVO NORDISK drugs in thirty-four countries.

Summary for Applicant: Novo Nordisk

Patents:29
Tradenames:48
Ingredients:31
NDAs:40
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;INJECTION021148-010Mar 1, 2010RXNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
INSULIN NORDISK MIXTARD (PORK)
insulin purified pork; insulin susp isophane purified pork
INJECTABLE;INJECTION018195-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-011Jan 23, 2015RXNoNo► 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► SubscribeYY ► 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
NOVOLOG MIX 50/50
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021810-001Aug 26, 2008► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-009Mar 1, 2010► 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;INJECTION021148-011Jan 23, 2015► Subscribe► Subscribe
Novo Nordisk Inc
NOVOLOG
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-001Jun 7, 2000► 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
9,616,180Automatic injection device with a top release mechanism► 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
8,357,120Injection device with torsion spring and rotatable display► 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
Norway320213► Subscribe
China1509193► Subscribe
European Patent Office1660531► Subscribe
European Patent Office2109474► Subscribe
European Patent Office1687019► 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
2009004,C0770388Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
00596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
101Luxembourg► Subscribe91101, EXPIRES: 20190601
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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 500+ biopharmaceutical companies globally:

Farmers Insurance
Express Scripts
Cerilliant
Merck
Johnson and Johnson
Fuji
Citi
McKinsey
Mallinckrodt
Cantor Fitzgerald

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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