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LANTUS SOLOSTAR Drug Profile

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When do Lantus Solostar patents expire, and when can generic versions of Lantus Solostar launch?

Lantus Solostar is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are seventeen patents protecting this drug.

This drug has one hundred and eighty-six patent family members in twenty-seven countries.

The generic ingredient in LANTUS SOLOSTAR is insulin glargine recombinant. There are thirty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for LANTUS SOLOSTAR

International Patents:	186
US Patents:	17
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Clinical Trials:	142
Drug Prices:	see details
DailyMed Link:	LANTUS SOLOSTAR at DailyMed

Pharmacology for LANTUS SOLOSTAR

Ingredient-type	Insulin
Drug Class	Insulin Analog

US Patents and Regulatory Information for LANTUS SOLOSTAR

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	LANTUS SOLOSTAR	insulin glargine recombinant	INJECTABLE;INJECTION	021081-002	Apr 27, 2007		RX	Yes	Yes
Sanofi Aventis Us	LANTUS SOLOSTAR	insulin glargine recombinant	INJECTABLE;INJECTION	021081-002	Apr 27, 2007		RX	Yes	Yes			Y
Sanofi Aventis Us	LANTUS SOLOSTAR	insulin glargine recombinant	INJECTABLE;INJECTION	021081-002	Apr 27, 2007		RX	Yes	Yes			Y
Sanofi Aventis Us	LANTUS SOLOSTAR	insulin glargine recombinant	INJECTABLE;INJECTION	021081-002	Apr 27, 2007		RX	Yes	Yes			Y

Non-Orange Book US Patents for LANTUS SOLOSTAR

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
8,663,175	Drive mechanisms suitable for use in drug delivery devices
8,070,727	Drive mechanisms suitable for use in drug delivery devices
7,905,867	Pen-type injector
9,623,190	Pen-type injector

International Patents for LANTUS SOLOSTAR

Country	Document Number	Estimated Expiration
Slovenia	2263723
Denmark	2011531
Spain	2304607
China	1780652

Supplementary Protection Certificates for LANTUS SOLOSTAR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
34/2000	Austria		PRODUCT NAME: LANTUS - INSULIN GLARGIN
13/34	Ireland		PRODUCT: 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
00019	Netherlands		PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
C0009	France		PRODUCT 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