Data from Pharmawand - Curated by Marshall Pearce - 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.


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