Hikma acquires Novugen’s FDA-approved ANDA for generic Mekinist

Hikma has acquired the FDA-approved Abbreviated New Drug Application for trametinib tablets from Novugen. Hikma also has entered into a commercial agreement with Novugen where Hikma will be responsible for all U.S. sales and marketing of this product, which Novugen will manufacture and supply to Hikma.

When launched, Hikma will have 180 days of U.S. generic market sales exclusivity for this product, which is the generic of Mekinist.

“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 U.S. patients and healthcare providers,” said Hafrun Fridriksdottir, president of Hikma generics. “Our acquisition of this cancer treatment strengthens our broad U.S. pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans.”

[Read more: Hikma gets FDA nod for generic Victoza, launches 2 new generics]

“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 United States,” said Rahil Mahmood, CEO 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 U.S. patients.  With Hikma’s strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy."

Mekinist had a market value of approximately $436 million in the 12 months ending December 2024, per IQVIA.