Vortioxetine

For the clinical treatment of major depressive disorder in adults, multi-mode acting drugs with both efficacy and safety are becoming a rigid clinical demand. Vortioxetine is a new generation of antidepressant. By inhibiting the reuptake of 5-hydroxytryptamine transporter and regulating multiple 5-hydroxytryptamine receptor subtypes at the same time, it can not only rapidly improve the core symptoms of depression such as low mood and anhedonia, but also effectively relieve the cognitive impairment associated with depression, and reduce the risk of common adverse reactions of traditional antidepressants such as sexual dysfunction and weight gain. It is currently a recommended drug for initial treatment and maintenance treatment of major depressive disorder in adults, especially suitable for patients with cognitive impairment or intolerance to traditional antidepressants.

At present, the global antidepressant market size has exceeded 17 billion US dollars, among which the compound annual growth rate of multi-target innovative drugs remains above 8%, which is significantly higher than that of traditional single-target drugs. As a representative variety in this field, vortioxetine's global sales exceeded 1.6 billion US dollars in 2023, and its sales at the terminal of public medical institutions in China exceeded 1.5 billion yuan, with an annual growth rate of 23%. At present, more than 10 domestic enterprises have submitted marketing applications for its generic drugs. Following the upsurge of generic declaration after the expiration of the core patent in 2022, this variety has been included in the seventh batch of national centralized drug procurement, and the winning price has dropped by more than 70% compared with the original drug, and the penetration rate in the primary market will be further improved in the future.

The original vortioxetine was jointly developed by Lundbeck of Denmark and Takeda Pharmaceutical of Japan, with the original brand name "Brintellix". Its compound patent in China expired in October 2022, and its crystal form patent will expire in 2033. The currently approved original dosage form is tablet, with three specifications of 5mg, 10mg and 20mg. It has been included in the Reference Listed Drug Catalogue of the China Listed Drug Catalogue, and is also included in the FDA Reference Listed Drug Catalogue. Up to now, there are more than 20 registration records of vortioxetine API on the CDE API registration platform, among which more than 10 have passed the associated review with preparations, and 7 domestic enterprises have obtained approval for the marketing of generic vortioxetine tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of vortioxetine, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully support enterprises in impurity research, quality standard establishment and generic drug consistency evaluation.