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Serving leading biopharmaceutical companies globally:

Novartis
Chinese Patent Office
Boehringer Ingelheim
Mallinckrodt
Deloitte
Farmers Insurance
Teva
Merck
Harvard Business School
Argus Health

Generated: December 11, 2017

DrugPatentWatch Database Preview

ADLYXIN Drug Profile

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Which patents cover Adlyxin, and what generic alternatives are available?

Adlyxin is a drug marketed by Sanofi-aventis Us and is included in one NDA. There are ten patents protecting this drug.

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

The generic ingredient in ADLYXIN is lixisenatide. One supplier is listed for this compound. Additional details are available on the lixisenatide profile page.

Summary for ADLYXIN

Drug patent expirations by year for ADLYXIN

Pharmacology for ADLYXIN

US Patents and Regulatory Information

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

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 Tradename: ADLYXIN

Country Document Number Estimated Expiration
Australia781338► Subscribe
Spain2200892► Subscribe
Taiwan201023931► Subscribe
European Patent Office2624893► Subscribe
World Intellectual Property Organization (WIPO)2013030160► Subscribe
Russian Federation2012123739► Subscribe
Portugal2750699► Subscribe
World Intellectual Property Organization (WIPO)2012045793► Subscribe
European Patent Office2624894► Subscribe
Dominican RepublicP2012000132► 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: ADLYXIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00018Denmark► Subscribe
/2013Austria► SubscribePRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
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
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
6Finland► Subscribe
175Luxembourg► SubscribePRODUCT NAME: LIXISENATIDE
C0021France► SubscribePRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001 20130201
2013000036Germany► SubscribePRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Healthtrust
Medtronic
Daiichi Sankyo
Covington
UBS
US Army
US Department of Justice
Baxter

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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