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Insulin degludec - Generic Drug Details

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

This ingredient has one hundred and eighteen patent family members in twenty-one countries.

There are thirty-eight drug master file entries for insulin degludec. One supplier is listed for this compound.

Summary for Generic Name: insulin degludec

Tradenames:1
Patents:9
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: insulin degludec

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYes► subscribe► subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYes8,672,898► subscribeY ► subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXNo9,108,002► subscribeY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,357,120Injection device with torsion spring and rotatable display► subscribe
8,828,923Insulin derivatives► 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 degludec

Country Document Number Estimated Expiration
Japan4827922► subscribe
Russian Federation2006103280► subscribe
China1829738► 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 DEGLUDEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130013 00086Estonia► subscribePRODUCT NAME: DEGLUDEKINSULIIN;REG NO/DATE: (2013) 637 (LOPLIK) COR. 21.01.2013
2013 00030Denmark► subscribe
00021Netherlands► subscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
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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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