Flibanserin

As the first drug approved globally for the treatment of hypoactive sexual desire disorder (HSDD) in women, flibanserin is a 5-hydroxytryptamine 1A receptor agonist and 5-hydroxytryptamine 2A receptor antagonist. By regulating the balance of dopamine, norepinephrine and 5-hydroxytryptamine in the central nervous system, it reduces the level of inhibitory neurotransmitters while increasing the concentration of excitatory neurotransmitters. It is specifically indicated for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women, which can significantly improve the libido level of patients and reduce sex-related distress, filling the long-standing clinical gap in the field of female sexual dysfunction treatment.

The global market size related to flibanserin has maintained steady growth in recent years. In 2023, the overall market size has exceeded USD 180 million, with a compound annual growth rate maintained at around 7%. Due to the overall low consultation rate of female sexual dysfunction, the market penetration rate is still less than 3%. With the popularization of patient education and the improvement of clinical recognition in the future, there is still considerable growth space in the market. At present, the market is dominated by the original research product, and the number of generic drug applications is small. No generic drug has been approved for marketing in China, and there is no relevant record of this variety being included in the centralized volume-based procurement.

The original research enterprise of flibanserin is Boehringer Ingelheim of the United States, and later the rights and interests were transferred to Sprout Pharmaceuticals. The brand name of the original drug is Addyi. The earliest expiration date of its US patents is 2023, and some dosage form-related patents will expire in 2031. The main dosage form of the original drug is oral tablet with a specification of 100 mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, no flibanserin preparation product has been approved for marketing in China, and no valid DMF information of registered flibanserin API has been found on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for flibanserin API. Most products are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can fully meet the reference standard use needs in the whole process of API R&D, quality research and registration declaration.