FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Generics Maker Sues Lachman for Missing First-Filer Deadline

Dec. 1, 2017

Greek generic drugmaker Pharmathen filed a lawsuit against Lachman Consultant Services, blaming it for a failure to obtain exclusive rights to market a generic for Biogen’s psoriasis treatment Tecfidera.

The lawsuit, filed in the Southern District of New York, alleges negligence and breach of contract by Lachman, which was responsible for preparing the generics maker’s ANDA. Lachman, the complaint claims, cost Pharmathen its chance at “first-filer” status when the firm failed to file the ANDA by the March 27 deadline as promised in the consulting agreement.

Pharmathen is seeking damages equal to the amount paid to Lachman, the revenues it would have earned from the ANDA and its research and development costs.

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