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Serving 500+ biopharmaceutical companies globally:

McKesson
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Farmers Insurance
QuintilesIMS
Boehringer Ingelheim
Cipla
Chinese Patent Office
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Generated: July 24, 2017

DrugPatentWatch Database Preview

Insulin aspart; insulin degludec - Generic Drug Details

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What are the generic sources for insulin aspart; insulin degludec and what is the scope of insulin aspart; insulin degludec freedom to operate?

Insulin aspart; insulin degludec
is the generic ingredient in one branded drug marketed by Novo Nordisk Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart; insulin degludec has one hundred and forty-seven patent family members in twenty-four countries.

There are thirty-eight drug master file entries for insulin aspart; insulin degludec.

Summary for Generic Name: insulin aspart; insulin degludec

Tradenames:1
Patents:12
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Clinical Trials: see list3,999
Drug Prices:see low prices
DailyMed Link:insulin aspart; insulin degludec at DailyMed
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
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin aspart; insulin degludec

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin aspart; insulin degludec

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
8,096,978Automatic injection device with a top release mechanism► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
9,616,180Automatic injection device with a top release mechanism► 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; insulin degludec

Country Document Number Estimated Expiration
Russian Federation2008152033► Subscribe
Canada2594764► Subscribe
Japan5568157► Subscribe
BrazilPI0413276► Subscribe
Denmark1804865► 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; INSULIN DEGLUDEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00033Denmark► Subscribe
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2004005,C0792290Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
QuintilesIMS
AstraZeneca
Healthtrust
Farmers Insurance
Argus Health
Chinese Patent Office
Queensland Health
Cantor Fitzgerald
Express Scripts

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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