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Liraglutide recombinant - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for liraglutide recombinant?

Liraglutide recombinant is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Liraglutide recombinant has two hundred and seventy-one patent family members in twenty-six countries.

There are six drug master file entries for liraglutide recombinant. Two suppliers are listed for this compound.

Summary for Generic Name: liraglutide recombinant

Tradenames:2
Patents:19
Applicants:1
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packagers: see list2
Bulk Api Vendors: see list1
Clinical Trials: see list728
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:liraglutide recombinant at DailyMed

Pharmacology for Ingredient: liraglutide recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes8,114,833► SubscribeY ► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes6,004,297► SubscribeY ► Subscribe
Novo Nordisk Inc
SAXENDA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes9,486,588► SubscribeY ► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes9,265,893► SubscribeY ► Subscribe
Novo Nordisk Inc
SAXENDA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes9,132,239► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: liraglutide recombinant

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
6,384,016 Stabilized aqueous peptide solutions► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
6,582,404 Dose setting limiter► Subscribe
6,235,004 Injection syringe► 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: liraglutide recombinant

Country Document Number Estimated Expiration
Germany69942305► Subscribe
Canada2584760► Subscribe
Australia748277► Subscribe
Israel182616► Subscribe
Japan2001011095► 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: LIRAGLUTIDE RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
C/GB09/058United Kingdom► SubscribePRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
C034/2009Ireland► SubscribeSPC034/2009: 20101001, EXPIRES: 20220821
0944648/01Switzerland► SubscribePRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
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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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