ETON - Eton Pharma gains on FDA approval for Elcys generic

Eton Pharmaceuticals (NASDAQ:ETON) has added ~12% in the pre-market on Monday after the Deer Park, Illinois-based company announced that the U.S. Food and Drug Administration (FDA) issued final approval for its cysteine hydrochloride abbreviated new drug application (ANDA). The product is a bioequivalent generic of ELCYS marketed by Exela Pharma Sciences as an additive to amino acid solutions to fulfill the nutritional needs of infants. ELCYS is also indicated for adult and pediatric patients with severe liver disease who require total parenteral nutrition (TPN). Being the first ANDA submitted against ELCYS, Eton (ETON) was granted 180 days of generic exclusivity, which begin with the commercial launch of the generic. The company is currently engaged in a legal dispute with Exela over the validity of cysteine patents. A court decision on the trial is expected in 3Q 2022. The current market for cysteine injection is estimated at over $50 million, according to IQVIA data.

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Eton Pharma gains on FDA approval for Elcys generic