Eton Pharmaceuticals & ANI Pharmaceuticals Announce Commercial Availability of Carglumic Acid Tablets, the First & Only FDA-Approved Generic Version of Carbaglu (carglumic acid)

Eton Pharmaceuticals, Inc. and ANI Pharmaceuticals, Inc. recently announced the commercial launch of Carglumic Acid tablets. The product will be marketed by Eton Pharmaceuticals and is the first and only FDA-approved generic version of Carbaglu. It was approved by the FDA for the treatment of acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. The product is AB-rated and is bioequivalent and therapeutically equivalent to Carbaglu, which allows pharmacies to substitute it in place of Carbaglu prescriptions. The product application is owned by Novitium Pharmaceuticals, a subsidiary of ANI Pharmaceuticals.

“We are excited to offer patients a convenient Carglumic Acid product that does not require refrigeration and to provide it at a lower price than the existing Carbaglu. We believe the adoption of our product will result in significant financial savings to the U.S. healthcare system and to many patients through lower co-pay and co-insurance costs,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

The product application was granted Competitive Generic Therapy (CGT) designation by the FDA, and as a result, the product is expected to receive 180 days of generic exclusivity. “This approval further strengthens ANI’s focus on niche opportunities and maintains our leadership position in Competitive Generic Therapy approvals,” said Nikhil Lalwani, CEO Of ANI Pharmaceuticals.

Carglumic Acid tablets are available exclusively through Anovo, a specialty pharmacy dedicated to serving patients with rare and chronic conditions. Anovo will administer the Eton Cares Program in partnership with Eton Pharmaceuticals. The program will provide prescription fulfillment, insurance benefits investigation, educational support, aid qualified patients to obtain financial assistance along with other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for $0 co-pays for qualifying patients.

Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE, Carglumic Acid, Biorphen, Alaway Preservative Free, Rezipres, and Eprontia, and has four additional products that have been submitted to the FDA.

ANI Pharmaceuticals is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. For more information, please visit www.anipharmaceuticals.com.