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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Chubb
Cipla
Covington
Farmers Insurance
Argus Health
Mallinckrodt
UBS
Baxter

Generated: May 24, 2018

DrugPatentWatch Database Preview

SOLIQUA 100/33 Drug Profile

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When do Soliqua 100/33 patents expire, and when can generic versions of Soliqua 100/33 launch?

Soliqua 100/33 is a drug marketed by Sanofi-aventis Us and is included in one NDA. There are twenty-three patents protecting this drug.

This drug has three hundred and fifty-one patent family members in forty-six countries.

The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are thirty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glargine; lixisenatide profile page.

US Patents and Regulatory Information for SOLIQUA 100/33

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;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi-aventis Us SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673-001 Nov 21, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for SOLIQUA 100/33

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 ➤ Sign Up
8,574,198 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
7,905,867 Pen-type injector ➤ Sign Up
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for SOLIQUA 100/33

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000114 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
C/GB00/022 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Julphar
AstraZeneca
Deloitte
Colorcon
QuintilesIMS
Healthtrust
Fuji

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