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Serving leading biopharmaceutical companies globally:

Teva
Argus Health
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Boehringer Ingelheim
Chinese Patent Office
Medtronic
Fuji
Colorcon
Moodys
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Generated: November 23, 2017

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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 sixty-two patent family members in twenty-four countries and forty-nine supplementary protection certificates in fifteen countries.

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

Summary for insulin aspart; insulin degludec

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► Subscribe► 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► 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
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
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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
7,686,786Dial-down mechanism for wind-up pen► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
8,828,923Insulin derivatives► Subscribe
9,616,180Automatic injection device with a top release mechanism► Subscribe
8,096,978Automatic injection device with a top release mechanism► 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
European Patent Office2287184► Subscribe
European Patent Office1804865► Subscribe
HungaryS1300033► Subscribe
Russian Federation2008152033► Subscribe
Russian Federation2401134► Subscribe
Czech Republic9803956► Subscribe
Russian Federation2182015► Subscribe
European Patent Office2264065► Subscribe
Japan2008516712► Subscribe
Australia2009306387► 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
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
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
0130013 00086Estonia► SubscribePRODUCT NAME: DEGLUDEKINSULIIN;REG NO/DATE: (2013) 637 (LOPLIK) COR. 21.01.2013
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
/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
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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Serving leading biopharmaceutical companies globally:

Cerilliant
Farmers Insurance
Mallinckrodt
Chinese Patent Office
Healthtrust
Medtronic
Fish and Richardson
Federal Trade Commission
Moodys
Merck

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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