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Generated: September 19, 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 list4,027
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► 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► 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
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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
9,616,180Automatic injection device with a top release mechanism► Subscribe
8,096,978Automatic injection device with a top release mechanism► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
7,686,786Dial-down mechanism for wind-up pen► 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
China100571805► Subscribe
Poland330763► Subscribe
China101107032► Subscribe
South Africa200600846► Subscribe
Czech Republic9803956► Subscribe
Denmark1819382► Subscribe
Russian Federation2182015► Subscribe
Portugal2275439► Subscribe
Australia3253697► Subscribe
Japan2007523881► 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
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
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
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
2013 00033Denmark► Subscribe
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
/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
2013 00030Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Fuji
Accenture
Cantor Fitzgerald
Covington
AstraZeneca
Dow
Fish and Richardson
Farmers Insurance
Teva

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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