Ailex Pharmaceuticals

Ailex Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of high-value generic and 505(b)(2) drug products. The company is best known for receiving the first FDA approval for a generic version of Helidac Therapy, a combination treatment for Helicobacter pylori infection and duodenal ulcer disease. Ailex operates through its US-based entity, Ailex Pharmaceuticals, LLC, and is closely associated with the pharmaceutical development firm RD2RX (Research Development to Rx). While some industry directories have listed the US operations as inactive, recent FDA inspections in early 2025 indicate ongoing regulatory engagement. The company also maintains an active presence in India through Ailex Pharmaceuticals Private Limited, which was incorporated in 1995.