Eton Pharma Gets Final FDA Approval For Cysteine Hydrochloride ANDA

(RTTNews) - Eton Pharmaceuticals, Inc (ETON) announced Monday that it has received final approval from the U.S. Food and Drug Administration (FDA) for its cysteine hydrochloride abbreviated new drug application (ANDA), a bioequivalent generic of Exela Pharma Sciences' Elcys.

Eton was granted 180 days of generic exclusivity as a result of being the first ANDA submitted against the reference product. The 180-day exclusivity period will begin upon Eton's commercialization of the product.

Cysteine is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants. Prior to 2019, cysteine was sold in the United States as a "grandfathered" or "unapproved" product.

Eton is currently engaged with Exela in paragraph IV litigation regarding the validity of Exela's cysteine patents. The trial was held in March 2022 and the company expects a decision from the judge in the third quarter of 2022.

Based on IQVIA data, the current market for cysteine injection is more than $50 million annually.