Data from Pharmawand - Curated by EPG Health - Date added 11 August 2017

Sanofi announced have brought on 8 August 2017 an infringement action against Merck Sharp & Dohme Corp. ("Merck") in the district court of New Jersey (United States District Court for the District of New Jersey), in the United States. The Sanofi complaint about infringement of two patents.

The complaint was prompted by a notification, received from Merck late June, in which Merck is said to have applied to the FDA for approval new drug (New Drug Application - NDA (505 (b) (2)) for insulin glargine in a bottle. Merck also stated that its application for approval included a certification "paragraph IV", challenging all Sanofi patents listed in the Orange Book of the FDA for Lantus® and Lantus® SoloStar® from Sanofi products.

Comment: The FDA has issued a tentative approval for Lusduna (insulin glargine biosimilar) in July 2017 and the biosimilar was EU approved in January 2017.


You will need to login, to leave a comment. is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Communicating Metastatic Breast Cancer Learning Zone

Communicating Metastatic Breast Cancer Learning Zone

This learning zone offers a short overview of the challenges faced by both healthcare professionals and patient when communicating end-stage or metastatic cancer.

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD)

View highlights from recent congresses presented in new expert videos with leading physicians.

+ 7 more

Load more

Related Content