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LANTUS SOLOSTAR Drug Profile
When do Lantus Solostar patents expire, and when can generic versions of Lantus Solostar launch?
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081-002 | Apr 27, 2007 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081-002 | Apr 27, 2007 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Sanofi Aventis Us | LANTUS SOLOSTAR | insulin glargine recombinant | INJECTABLE;INJECTION | 021081-002 | Apr 27, 2007 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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 | ➤ Try a Free Trial |
8,070,727 | Drive mechanisms suitable for use in drug delivery devices | ➤ Try a Free Trial |
7,905,867 | Pen-type injector | ➤ Try a Free Trial |
9,623,190 | Pen-type injector | ➤ Try a Free Trial |
Patent No. | Title | Estimated Patent Expiration |
International Patents for LANTUS SOLOSTAR
Country | Document Number | Estimated Expiration |
---|---|---|
Slovenia | 2263723 | ➤ Try a Free Trial |
Denmark | 2011531 | ➤ Try a Free Trial |
Spain | 2304607 | ➤ Try a Free Trial |
China | 1780652 | ➤ Try a Free Trial |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for LANTUS SOLOSTAR
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
34/2000 | Austria | ➤ Try a Free Trial | PRODUCT NAME: LANTUS - INSULIN GLARGIN |
13/34 | Ireland | ➤ Try a Free Trial | 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 | ➤ Try a Free Trial | 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 | ➤ Try a Free Trial | 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 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |