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Serving 500+ biopharmaceutical companies globally:

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Federal Trade Commission
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Generated: June 28, 2017

DrugPatentWatch Database Preview

Insulin aspart recombinant - Generic Drug Details

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What are the generic drug sources for insulin aspart recombinant and what is the scope of insulin aspart recombinant patent protection?

Insulin aspart recombinant
is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart recombinant has one hundred and eighty-four patent family members in twenty-two countries.

There are thirty-eight drug master file entries for insulin aspart recombinant. Three suppliers are listed for this compound.

Summary for Generic Name: insulin aspart recombinant

Tradenames:5
Patents:15
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list3
Clinical Trials: see list5,365
Drug Prices:see low prices
DailyMed Link:insulin aspart recombinant at DailyMed

Pharmacology for Ingredient: insulin aspart recombinant

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 PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 2000RXYesYes5,866,538*PED► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXTOUCH
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-005Oct 31, 2013RXYesYes9,486,588► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 2004DISCNNoNo5,866,538*PED► SubscribeY► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYes6,004,297► SubscribeY ► Subscribe
Novo Nordisk Inc
NOVOLOG FLEXPEN
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-003Jan 19, 2001RXYesYesRE41956► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin aspart recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
NOVOLOG PENFILL
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-002Jun 7, 20005,626,566*PED► Subscribe
Novo Nordisk Inc
NOVOLOG
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-001Jun 7, 20005,618,913*PED► Subscribe
Novo Nordisk Inc
NOVOLOG INNOLET
insulin aspart recombinant
INJECTABLE;SUBCUTANEOUS020986-004Apr 23, 20045,618,913*PED► Subscribe
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, 20005,693,027*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin aspart recombinant

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
8,096,978Automatic injection device with a top release mechanism► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
6,235,004 Injection syringe► Subscribe
6,582,404 Dose setting limiter► 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 Ingredient: insulin aspart recombinant

Country Document Number Estimated Expiration
European Patent Office1351732► Subscribe
Poland189964► Subscribe
South Korea101300496► Subscribe
Hungary9904031► Subscribe
Brazil9906857► 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: INSULIN ASPART RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
Moodys
Cipla
Dow
QuintilesIMS
McKinsey
Express Scripts
Boehringer Ingelheim
Queensland Health
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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