Hikma acquires Novugen’s FDA-approved ANDA for trametinib
London, 17 April 2025 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma.
Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.
“Hikma’s Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers,” said Dr. Hafrun Fridriksdottir, president of Hikma Generics. “Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans.”
“As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US,” said Rahil Mahmood, Chief Executive Officer of Novugen. “This exclusive first-to-file molecule is a testament to Novugen's innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma’s strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy."
According to IQVIA, US sales of trametinib, sold under the brand name Mekinist® (trametinib) Tablets, were approximately $436 million in the 12 months ending December 2024.
Hikma’s Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US1.
1 IQVIA MAT December 2024, volumes by eaches
Mekinist® is a registered trademark of Novartis Pharma AG
This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.