Hikma Launches First Generic Mercaptopurine Oral Suspension in the US

Hikma Pharmaceuticals PLC has received FDA approval and launched the first generic Mercaptopurine Oral Suspension (20mg/mL) in the United States, marking a significant milestone in oncology treatment accessibility. The approval was granted under the Competitive Generic Therapy (CGT) designation, making Hikma the first applicant and securing 180 days of market exclusivity. Mercaptopurine Oral Suspension is widely used in combination chemotherapy regimens for treating acute lymphoblastic leukemia (ALL), a common pediatric cancer. The product's US sales reached approximately $14 million in the 12 months ending December 2024, according to IQVIA.

Hikma’s internal R&D team spearheaded the development, reinforcing the company’s commitment to expanding access to high-quality oncology treatments. Hafrun Fridriksdottir, President of Hikma’s Generics business, emphasized the company’s dedication to enhancing patient access to essential medicines. With a strong presence in the US generics market, Hikma continues to lead in complex drug formulations, including nasal sprays and inhalation therapies, further cementing its role as a key player in pharmaceutical innovation.