Vardenafil

Male erectile dysfunction (ED) is a common reproductive system disease in adult males. Its global prevalence shows an upward trend with age, and it exerts multiple negative impacts on patients' quality of life and mental health. Vardenafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor. It reduces the degradation of cyclic guanosine monophosphate (cGMP) by specifically inhibiting the activity of PDE5, relaxes the smooth muscle of the corpus cavernosum of the penis, and promotes blood inflow, thus improving erectile function. This drug has definite therapeutic effects on psychological, organic and mixed ED, with fast onset of action and low incidence of adverse reactions. Meanwhile, it has good applicability and safety for ED patients with comorbid diabetes and hypertension.

The global number of ED patients has exceeded 150 million, driving the continuous expansion of the PDE5 inhibitor market. In 2023, the global market size of related products was close to 7 billion US dollars, and the market size in China exceeded 4 billion yuan, with a compound annual growth rate remaining above 8%. In terms of the competitive landscape, generic products of this category account for more than 65% of the market share. More than 20 domestic enterprises have obtained approval for generic preparations, and the average price reduction in provincial centralized procurement has reached 70%. The demand for upstream API continues to rise along with the expansion of preparation production capacity. At present, fewer than 10 domestic enterprises can mass-produce this API, and the supply gap is still relatively obvious.

The original research enterprise of vardenafil is Bayer HealthCare Co., Ltd., and the original brand name is "Levitra". Its compound patent in China expired in 2018. The main dosage form approved for the original product is tablet, with specifications including 5mg, 10mg and 20mg. The original preparation has been included in the China Listed Drug Catalogue as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalog. Up to now, there are 8 vardenafil API registration records on the API registration platform of China CDE, among which 5 are in activated status, and nearly 30 domestic enterprises have obtained approval for marketing of vardenafil tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of vardenafil impurity reference standards. 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 compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for all links of API R&D, quality research and preparation declaration, helping enterprises effectively control impurity risks and accelerate the product launch process.