Apomorphine

In the clinical treatment of central nervous system degenerative diseases and male erectile dysfunction, dopamine receptor agonists are one of the core medication categories. As a non-selective dopamine D1/D2 receptor agonist, apomorphine can stimulate hypothalamic dopamine receptors, activate the parasympathetic pathway to induce corpus cavernosum smooth muscle relaxation. Meanwhile, it can also be used for symptom improvement of Parkinson's disease, as well as for the diagnosis and treatment of opioid addiction. The main clinically applicable population includes erectile dysfunction patients who have no response to or are intolerant to oral phosphodiesterase 5 inhibitors, and some Parkinson's disease patients who need to improve motor symptoms, filling the medication gap for specific populations.

The global market size of apomorphine-related preparations has maintained a steady growth trend in recent years. In 2023, the overall market size was approximately USD 210 million, with a compound annual growth rate of about 4.7%. The growth momentum mainly comes from the increase in the number of patients with erectile dysfunction and the release of demand for individualized treatment of Parkinson's disease. In terms of competitive landscape, the original research product accounts for about 35% of the global market share, and European and Indian enterprises are the main providers of generic versions. At present, there are no mass-produced generic drugs launched in the domestic market, and part of the clinical demand relies on imports. In the future, with the advancement of generic drug applications after patent expiration, the market accessibility is expected to be further improved.

The original research enterprise of apomorphine is Mylan Laboratories Inc. from the United States, with the original brand name Apokyn. The compound patent in the US market expired in 2017, and the core patent in China has also expired. The main dosage forms approved for the original product are injections and sublingual tablets. The specification of the injection is 30mg/3ml, and the specifications of the sublingual tablets are 2mg and 3mg. Both dosage forms have been included in the FDA Reference Listed Drug Catalog. At present, 2 batches of apomorphine API have obtained CDE registration numbers in China, both with the status of A. Meanwhile, imported sublingual tablet preparations have been approved for marketing, but no domestic apomorphine preparation has been approved yet. (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 apomorphine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, which can fully meet the reference standard use needs of pharmaceutical enterprises in all links of R&D, quality research and production.