FDA Clears First Elcys Generic

The generic cysteine could be available after a ruling in a patent dispute, which is expected in the third quarter of 2022.

Even while Eton Pharmaceuticals is involved in a legal battle with Exela Pharma Sciences, the FDA cleared Eton’s generic for Exela’s cysteine hydrochloride (Elcys). Cysteine is used as an additive to meet nutritional needs of infants.

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 when Eton begins commercialization of the product.

The current market for cysteine injection is more than $50 million annually, according to IQVIA, Eton said in a news release.

Eton has been battling Exela since 2019 regarding the validity of Exela’s cysteine patents. A trial was held in March 2022, and Eton expects a decision from the judge in the third quarter of 2022.

“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.

Exela did not respond to a request for comment from FormularyWatch®.

Prior to 2019, cysteine was sold in the United States as a “grandfathered” or “unapproved” product, according to Eton. The FDA grandfathered any pharmaceutical product that was available prior to 1938 before the agency required a new drug application with safety data. But through a compliance policy, the regulatory agency has encouraged companies to seek new drug applications for these products.

In 2019, Exela Pharma Sciences received FDA approval of its version of cysteine. At the time, Exela claimed it had conducted research and produced a product with a lower aluminum content.

But according to Eton, Exela more than tripled the price of the product to its current price of $82 per vial from the grandfathered product price of $22.

Meanwhile, Eton said its 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, and as a result, Eton believes Exela’s patents are invalid and should not have been issued by the U.S. Patent and Trademark Office.”