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Generated: July 28, 2017

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RYZODEG 70/30 Drug Profile

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What is the patent landscape for Ryzodeg 70/30, and when can generic versions of Ryzodeg 70/30 launch?

Ryzodeg 70/30 is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and forty-seven patent family members in twenty-four countries.

The generic ingredient in RYZODEG 70/30 is insulin aspart; insulin degludec. There are thirty-eight drug master file entries for this compound. Additional details are available on the insulin aspart; insulin degludec profile page.

Summary for Tradename: RYZODEG 70/30

Patents:11
Applicants:1
NDAs:1
Clinical Trials: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RYZODEG 70/30 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► SubscribeYY ► 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► Subscribe► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: RYZODEG 70/30

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 Tradename: RYZODEG 70/30

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 Tradename: RYZODEG 70/30

Country Document Number Estimated Expiration
Russian Federation2388498► Subscribe
China101107031► Subscribe
European Patent Office2373361► Subscribe
Denmark2373361► Subscribe
Germany602005017182► 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: RYZODEG 70/30

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
8 5015-2013Slovakia► SubscribePRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
00160Netherlands► SubscribePRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
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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
Julphar
Mallinckrodt
US Department of Justice
QuintilesIMS
Farmers Insurance
Queensland Health
Moodys
Johnson and Johnson
Baxter

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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