FDA Grants Approval to Eton Pharmaceuticals’ Cysteine Hydrochloride Injection

The U.S. Food and Drug Administration granted approval to Eton Pharmaceuticals for its cysteine hydrochloride abbreviated new drug application, a bioequivalent generic of Exela Pharma Sciences’ Elcys, which is used for infants requiring total parenteral nutrition and adults and pediatric patients with severe liver diseases and impaired enzymatic processes.

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.

“Despite Exela’s attempts to monopolize a decades old treatment with patents that we believe to be frivolous, we are eager to provide a lower cost product to newborn infants that need cysteine,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

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. In 2019, Exela Pharma Sciences received FDA approval of its product, which contains the same formulation as the “grandfathered” versions, and Exela Pharma Sciences more than tripled the price of the product to its current price of $82 per vial from the “grandfathered” product price of $22.

Eton’s partner has manufactured the product in its current formulation as far back as 2003, well before Exela Pharma Sciences began working on its product or filed its patent. As a result, Eton said, it believes Exela’s patents are invalid and should not have been issued by the United States Patent and Trademark Office.

Eton is currently engaged with Exela in 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.

The current market for cysteine injection is more than $50 million annually, according to the life sciences intelligence service IQVIA.

Author: Rare Daily Staff