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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Cantor Fitzgerald
QuintilesIMS
US Army
Fish and Richardson
McKinsey
Fuji
US Department of Justice

Generated: September 19, 2018

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SOLIQUA 100/33 Drug Profile

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Which patents cover Soliqua 100/33, 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-five patents protecting this drug.

The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are forty 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.

Drug patent expirations by year for SOLIQUA 100/33
Generic Entry Opportunity Date for SOLIQUA 100/33
Generic Entry Date for SOLIQUA 100/33*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SOLIQUA 100/33

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 ➤ 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 ➤ 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
9,028,454 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
6,528,486 Peptide agonists of GLP-1 activity ➤ Sign Up
9,205,197 Drug delivery device dose setting mechanism ➤ Sign Up
7,553,299 Drive mechanisms suitable for use in drug delivery devices ➤ Sign Up
8,021,345 Pen-type injector ➤ Sign Up
7,935,088 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
C0021 France ➤ Sign Up PRODUCT NAME: LIXISENATIDE; REGISTRATION NO/DATE: EU/1/12/811/001 20130201
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
13/015 Ireland ➤ Sign Up PRODUCT 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
/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
60026 Netherlands ➤ Sign Up PRODUCT 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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Cantor Fitzgerald
QuintilesIMS
US Army
Fish and Richardson
McKinsey
Fuji
US Department of Justice

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.