Novartis’ blockbuster drug Tasigna (nilotinib) is set to lose its exclusive status in the US in January 2024. A pivotal treatment for chronic myeloid leukemia (CML), with forecasted 2023 sales of $1.8 billion, Tasigna faces a significant sales decline. The impending US patent expiry, coupled with a prior EU patent loss, is anticipated to result in a 50% decrease in sales from 2023 to 2024. This shift is poised to reshape the CML drug market, fostering competition and improving patient accessibility, according to GlobalData, a leading data and analytics company.

The US is one of the most important markets for Tasigna, as it contributed 39% of the drug’s total historical revenue from 2008 to 2022. As such, the entry of Tasigna generics and reformulations will likely bring competitive pricing and increased accessibility to the CML space.

Tasigna is a small molecule Bcr-Abl tyrosine kinase inhibitor that works by inhibiting the abnormal Bcr-Abl tyrosine kinase receptor signaling that is responsible for the proliferation of CML cells. The FDA granted approval in 2007. Since then, it has been included on the World Health Organization’s Model List of Essential Medicines for the treatment of adult and pediatric CML.

Kevin Marcaida, Pharma Analyst at GlobalData, comments: “The looming US patent expiry, coupled with a prior EU patent expiry in July 2023, will set Tasigna up for a long-term decline in sales, which are projected to plummet from $1.8 billion in 2023 to just $79 million by the end of 2029.

“This decline will likely have a significant impact on the CML drug market, given that Tasigna currently accounts for nearly two-thirds of sales in 2023. The entry of generics will introduce increased competition, leading to lower prices and ultimately making the drug more accessible to a larger patient population.”

There are already eight generics and nilotinib re-formulations on the market or in development worldwide. This includes three nilotinib re-formulations that were actively developed in the US: KeifeRx LLC’s KFRX01, Xspray Pharma AB’s HyNap-Nilo, and Nanocopoeia LLC’s nilotinib.

Marcaida concludes: “Novartis is aware of the recent and upcoming patent expirations in two major markets and has proactively sought opportunities in other markets. In October 2022, the company entered into a historic voluntary licensing agreement with the Medicines Patent Pool, marking the first such deal involving cancer medicine. This deal permits select generics companies to manufacture Tasigna in eight countries, including India, Guatemala, Egypt, Indonesia, Morocco, Pakistan, the Philippines, and Tunisia. Furthermore, the agreement facilitates the distribution of nilotinib generics in 44 territories where patents are either pending or currently in force.”