June 25, 2024
Novartis's 20 largest products account for 77% of sales. With a number of LOEs coming up, Novartis has been bolstering its pipeline - here’s a look at its largest medicines by sales, and when they’ll begin facing competition:
Determining when a drug will face competition is complex, because each is protected by several types of patents, which expire at different times.
In Entresto’s case, key patents begin to expire in 2025, and generics manufacturers have already begun lawsuits challenging parts of its IP.
For Cosentyx, composition of matter patents begin to expire in 2026, but a patent term extension runs until 2029. Unlike Entresto, which is a small molecule, Cosentyx is a biologic, and is thus harder for generics manufacturers to replicate, meaning it will have a more gradual sales decline post LOE.
Several of Novartis’s fastest growing medicines have significant protection left, including oncology medicines Kisqali (sales growth of 75%) and Pluvicto (sales growth of 261%).
Kisqali recently released positive data at ASCO, showing improvements in disease free survival compared to endocrine therapy alone.
Meanwhile, Pluvicto has been achieving steady sales increases since its 2022 launch. One potential inflection point would come from Novartis’s plan to file for FDA approval in H2 2024 for pre-chemo treatment in prostate cancer, in addition to its current approval as an adjuvant treatment.
Pluvicto’s growth was previously hampered by supply issues, which raise an interesting nuance about radioligand therapies - they are complex to manufacture, and in many cases must be used within one week of manufacture in order to be effective.
Pluvicto specifically expires in 5 days from the date of manufacture, creating a significant logistical challenge.
Taking a step back, Novartis is poised to manage its upcoming patent cliff relatively well. Arguably a big part is thanks to its sharpened focus, enabled by several years of spinoffs and divestitures that have enabled it to focus more clearly on innovation.
Other large BioPharma companies have since undertaken similar divestitures (e.g., of consumer health divisions) so it will be interesting to see how those progress in relation to Novartis.
