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Serving leading biopharmaceutical companies globally:

Merck
Farmers Insurance
AstraZeneca
Medtronic
Deloitte
Johnson and Johnson
Cipla
McKinsey
Covington
Healthtrust

Generated: December 17, 2017

DrugPatentWatch Database Preview

INSULIN GLARGINE; LIXISENATIDE - Generic Drug Details

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

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

Insulin glargine; lixisenatide has three hundred and eleven patent family members in forty-three countries and fifty-one supplementary protection certificates in thirteen countries.

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

Summary for INSULIN GLARGINE; LIXISENATIDE

Pharmacology for INSULIN GLARGINE; 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 UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Sanofi-aventis UsSOLIQUA 100/33insulin glargine; lixisenatideSOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin glargine; 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
8,574,198Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,205,197Drug delivery device dose setting mechanism► Subscribe
7,553,299Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,663,175Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,526,843Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,876,782Drive mechanisms suitable for use in drug delivery devices► Subscribe
9,827,379Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,070,727Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,935,088Drive mechanisms suitable for use in drug delivery devices► Subscribe
8,888,750Pen-type injector► 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 glargine; lixisenatide

Country Document Number Estimated Expiration
European Patent Office2221077► Subscribe
South Korea20060010721► Subscribe
Cyprus1111400► Subscribe
Cyprus1114101► Subscribe
Portugal1601395► Subscribe
South Africa201203035► Subscribe
CroatiaP20050766► Subscribe
Cyprus1108604► Subscribe
Eurasian Patent Organization010390► Subscribe
Eurasian Patent Organization200501407► 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 GLARGINE; LIXISENATIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
/2013Austria► SubscribePRODUCT NAME: LIXISENATID; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
2013 00018Denmark► Subscribe
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
/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
00596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
00584Netherlands► SubscribePRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001-005 20130201
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
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Serving leading biopharmaceutical companies globally:

UBS
Accenture
Express Scripts
Covington
Teva
Dow
Cipla
Farmers Insurance
Moodys
Fuji

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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