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Serving leading biopharmaceutical companies globally:

Argus Health
Mallinckrodt
Cantor Fitzgerald
Teva
US Army
Citi
Cerilliant
Moodys
Fish and Richardson
Accenture

Generated: December 16, 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► 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► 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► 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
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
8,021,345Pen-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
Taiwan201026321► Subscribe
World Intellectual Property Organization (WIPO)2004078239► Subscribe
South Korea20110084956► Subscribe
China1376166► Subscribe
Israel214157► Subscribe
Portugal2263723► Subscribe
Austria497398► Subscribe
Australia2004216827► Subscribe
Austria474614► Subscribe
Colombia6361944► 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
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
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
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
2017000040Germany► SubscribePRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Cantor Fitzgerald
US Department of Justice
Chubb
Moodys
Citi
Cipla
Mallinckrodt
Merck

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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