Apremilast

There has long been an unmet need for oral treatment for chronic inflammatory diseases such as psoriasis and psoriatic arthritis. As a novel small-molecule phosphodiesterase 4 (PDE4) inhibitor, apremilast elevates the intracellular cyclic adenosine monophosphate level by inhibiting PDE4 activity, downregulates pro-inflammatory factors and upregulates anti-inflammatory factors, thus exerting an immunomodulatory effect. Its indications cover moderate to severe plaque psoriasis in adults, active psoriatic arthritis and Behçet's disease-related oral ulcers. It requires no routine medication monitoring, providing a more convenient option for patients intolerant to biological agents or conventional systemic treatment.

The global apremilast market size exceeded US$3.2 billion in 2023, with a compound annual growth rate of around 11% in the past three years. The core growth drivers are the rising prevalence of autoimmune diseases and the compliance advantage of oral preparations. The Chinese market has expanded rapidly since its approval in 2021, with in-hospital sales exceeding RMB 700 million in 2023. At present, more than 15 enterprises have submitted marketing applications for generic apremilast. As generic drugs enter the market after patent expiration, the decline in terminal prices will further promote the penetration of market coverage to the primary level.

The original developer of apremilast is Celgene Corporation (now acquired by Bristol-Myers Squibb), and the original brand name is Otezla®. Its compound patent in China will expire in 2028. The dosage form approved for the original drug is tablet, with specifications including 10mg, 20mg and 30mg. It has been included in the Chinese Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are more than 30 registration entries of apremilast API on the API registration platform of China's CDE, among which more than 10 entries are in the status of "A" (approved for use in marketed preparations). A total of 18 generic apremilast preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of apremilast impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and provide stable and reliable reference standard support for pharmaceutical enterprises in the links of API R&D, quality research and declaration.