Otsuka’s new formulations to offset Abilify Maintena dual patent expiry impact, says GlobalData

Otsuka Pharmaceutical is poised for a strategic transition as it approaches the loss of market exclusivity of Abilify Maintena (Aripiprazole) in Europe and the US in October 2024. This significant development signals a forthcoming shift in the drug’s sales trajectory, highlighting Otsuka’s readiness to embrace changes with new formulations for continued growth in mental health solutions, says GlobalData, a leading data and analytics company.

GlobalData’s Drugs Database reveals that the dual patent expiry of Abilify Maintena poses a risk to Otsuka’s sales and is expected to lead to a 12% reduction in sales from 2024 to 2025, which is projected to plummet by the end of 2029.

Abilify Maintena, an atypical antipsychotic medication for schizophrenia and bipolar I disorder, has been pivotal in Otsuka’s financial success, particularly in the US, which represents 49% of the drug’s total revenue from 2013 to 2023. The drug, which facilitates partial agonistic activity at key neurotransmitter receptors, is administered as a long-acting injectable (LAI) solution.

Eleni Tokali, Pharma Analyst at GlobalData, comments: "The upcoming patent expiry of Abilify Maintena is a critical moment for Otsuka, highlighting the challenges inherent in the pharmaceutical industry’s lifecycle management. The company’s adaptability in the face of patent expirations with new formulations showcases a robust pathway for sustained growth in mental health solutions.”

Otsuka’s proactive approach in expanding its LAI portfolio with Abilify Asimtufii, the first once-every-two-month LAI for the treatment of schizophrenia and bipolar I disorder, reflects the company’s focus on advancing psychiatric care solutions to face evolving market dynamics. The drug was launched in the US market in April 2023 and its patent is set to expire in the country in 2033.

Tokali concludes: "While a negative impact from Abilify Maintena patent expiry on Otsuka is expected due to increased competition and lower prices, this can be translated to a positive outcome for the wider market in terms of the accessibility of the drug to a larger patient population. Otsuka’s strategic initiatives, particularly in the development of new formulations like Abilify Asimtufii, which is a longer-acting version, reflect its commitment to market innovation and patient care.”