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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Harvard Business School
Healthtrust
Deloitte
UBS
Farmers Insurance
Medtronic
Argus Health
Chubb

Generated: November 20, 2017

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Lixisenatide - Generic Drug Details

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What are the generic drug sources for lixisenatide and what is the scope of lixisenatide freedom to operate?

Lixisenatide
is the generic ingredient in one branded drug marketed by Sanofi-aventis Us and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lixisenatide has two hundred and sixteen patent family members in thirty-eight countries and nine supplementary protection certificates in nine countries.

One supplier is listed for this compound.

Summary for lixisenatide

Pharmacology for lixisenatide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-001Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-001Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-001Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
ADLYXIN
lixisenatide
SOLUTION;SUBCUTANEOUS208471-002Jul 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lixisenatide

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
6,528,486 Peptide agonists of GLP-1 activity► 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: lixisenatide

Country Document Number Estimated Expiration
Russian Federation2573995► Subscribe
South Africa201103034► Subscribe
European Patent Office2112161► Subscribe
Australia2012300978► Subscribe
Australia2009250106► Subscribe
Denmark2112161► Subscribe
Hong Kong1140156► Subscribe
World Intellectual Property Organization (WIPO)2012045794► Subscribe
Israel218493► Subscribe
China102238972► 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: LIXISENATIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90021-2Sweden► SubscribePRODUCT NAME: LIXISENATID; REG. NO/DATE: EU/1/12/811/001 20130201
00584Netherlands► SubscribePRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
6Finland► Subscribe
13/015Ireland► SubscribePRODUCT NAME: LIXISENATIDE; NAT REGISTRATION NO/DATE: EU/1/12/811/001 20130201; FIRST REGISTRATION NO/DATE: EU/1/12/811/002 01/02/2013 IRELAND EU/1/12/811/003 01/02/2013 IRELAND EU/1/12/811/004 01/02/2013 IRELAND EU/1/12/811/005 20130201
175Luxembourg► SubscribePRODUCT NAME: LIXISENATIDE
2013000036Germany► SubscribePRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
/2013Austria► SubscribePRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
C0021France► SubscribePRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001 20130201
2013 00018Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
UBS
Cipla
Farmers Insurance
Fish and Richardson
Queensland Health
Merck
Accenture
Dow
Boehringer Ingelheim

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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