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Insulin aspart; insulin degludec - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for insulin aspart; insulin degludec?

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-six 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 list1,658
Drug Prices:see low prices
DailyMed Link:insulin aspart; insulin degludec at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes► Subscribe► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes9,457,154► SubscribeY ► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes8,684,969► SubscribeY ► Subscribe
Novo Nordisk Inc
RYZODEG 70/30
insulin aspart; insulin degludec
SOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015RXYesYes9,132,239► SubscribeY ► 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
8,096,978Automatic injection device with a top release mechanism► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
8,828,923Insulin derivatives► 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
Japan2013154219► Subscribe
South Africa200703707► Subscribe
Russian Federation2518460► Subscribe
Luxembourg92226► Subscribe
Russian Federation2182015► 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
8 5015-2013Slovakia► SubscribePRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
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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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