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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Accenture
US Army
Argus Health
Boehringer Ingelheim
Julphar
Healthtrust
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McKesson
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Generated: July 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 thirty-nine approved drugs.

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

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

Summary for Applicant: Novo Nordisk Inc

Patents:29
Tradenames:47
Ingredients:30
NDAs:39
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
INSULIN NORDISK MIXTARD (PORK)
insulin purified pork; insulin susp isophane purified pork
INJECTABLE;INJECTION018195-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Novo Nordisk Inc
NORDITROPIN FLEXPRO
somatropin recombinant
INJECTABLE;INJECTION021148-010Mar 1, 2010RXNoNo9,457,154► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes9,132,239► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000RXYesYes5,866,538*PED► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG MIX 70/30 FLEXPEN
insulin aspart protamine recombinant; insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS021172-004May 3, 2002RXYesYesRE43834► 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 PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 20005,618,913*PED► Subscribe
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 20005,626,566*PED► Subscribe
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 20005,693,027*PED► Subscribe
Novo Nordisk Inc
NORDITROPIN NORDIFLEX
somatropin recombinant
INJECTABLE;INJECTION021148-004Oct 1, 20045,849,704► Subscribe
Novo Nordisk Inc
NORDITROPIN
somatropin recombinant
INJECTABLE;INJECTION019721-001May 8, 19955,633,352► 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
8,828,923Insulin derivatives► Subscribe
8,097,698Derivatives of GLP-1 analogs► Subscribe
6,011,007 Acylated insulin► Subscribe
6,384,016 Stabilized aqueous peptide solutions► Subscribe
6,582,404 Dose setting limiter► 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
European Patent Office1056775► Subscribe
Norway20001559► Subscribe
Germany69916811► Subscribe
Japan5241849► Subscribe
Germany69942307► 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
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
/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 500+ biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
QuintilesIMS
Chinese Patent Office
Moodys
McKinsey
Medtronic
McKesson
Express Scripts
Fish and Richardson

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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