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Serving leading biopharmaceutical companies globally:

Cipla
Medtronic
US Department of Justice
Chubb
Express Scripts
QuintilesIMS
Julphar
McKesson
Farmers Insurance
McKinsey

Generated: October 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 eight patent family members in forty-two countries and forty-eight 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 Generic Name: insulin glargine; lixisenatide

US Patents:20
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list4,049
Drug Prices:see low prices
DailyMed Link:insulin glargine; lixisenatide at DailyMed

Pharmacology for Ingredient: 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 Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;SUBCUTANEOUS208673-001Nov 21, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Sanofi-aventis Us
SOLIQUA 100/33
insulin glargine; lixisenatide
SOLUTION;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
8,021,345Pen-type injector► Subscribe
9,526,843Drive mechanisms suitable for use in drug delivery devices► 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
9,623,190Pen-type injector► Subscribe
8,876,782Drive mechanisms suitable for use in drug delivery devices► Subscribe
7,905,867Pen-type injector► Subscribe
6,528,486 Peptide agonists of GLP-1 activity► Subscribe
9,205,197Drug delivery device dose setting mechanism► Subscribe
7,935,088Drive mechanisms suitable for use in drug delivery devices► 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
South Korea20060010721► Subscribe
SloveniaEP1974761► Subscribe
TaiwanI336237► Subscribe
European Patent Office1974761► Subscribe
TaiwanI340654► Subscribe
SloveniaEP1920794► Subscribe
Dominican RepublicP2012000132► Subscribe
Germany602004013558► Subscribe
Portugal1603611► Subscribe
Eurasian Patent Organization200501406► 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
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
6Finland► Subscribe
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
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
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Moodys
AstraZeneca
Fish and Richardson
Chinese Patent Office
Fuji
Cerilliant
Medtronic
Farmers Insurance
McKinsey

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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