Droxidopa

For neurological diseases such as neurogenic orthostatic hypotension that lack effective treatment options, droxidopa, a synthetic norepinephrine prodrug, can cross the blood-brain barrier and be converted into norepinephrine to replenish central and peripheral norepinephrine levels, thereby increasing upright blood pressure and improving related symptoms such as dizziness, fatigue and syncope. It is clinically mainly used for the treatment of neurogenic orthostatic hypotension associated with Parkinson's disease, and orthostatic hypotension symptoms caused by multiple system atrophy and pure autonomic failure. The applicable population covers adult patients with primary or secondary autonomic dysfunction, filling the gap in clinical medication for such special diseases.

The global droxidopa market size was approximately USD 320 million in 2023, with a compound annual growth rate maintained at around 6.8%. The growth momentum mainly comes from the rising prevalence of geriatric neurological diseases such as Parkinson's disease. The domestic market is still in the stage of rapid penetration at present, with the originator product occupying the major market share. Generic preparations from 3 domestic enterprises have been approved for marketing. Since it was included in the National Medical Insurance Catalog in 2021, its clinical utilization rate has increased significantly. In 2023, the sales volume of droxidopa in domestic sample hospitals exceeded RMB 120 million, with a year-on-year growth of 41%.

The originator enterprise of droxidopa is Japan's Mitsubishi Tanabe Pharma, with the original brand name "Northera". Its core patent in the US market expired in 2021, and the expiration date of its compound patent in China is 2022. The main dosage form approved for the originator product is oral tablet, with specifications of 100mg and 200mg. It has been included in the Catalogue of Marketed Drugs in China as the reference listed drug, and is also included in the FDA Reference Listed Drug Catalog. Up to now, droxidopa API from 8 domestic enterprises have obtained CDE registration numbers, among which 5 are in "A" status and can be used for associated domestic preparation applications. In addition, droxidopa tablets from 4 enterprises including the originator have been approved for marketing in China. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of droxidopa impurity reference standards, which strictly comply with the regulatory requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock. Spot orders paid before 16:00 can be shipped on the same day, which fully meets the reference standard supply needs of pharmaceutical enterprises in R&D, quality research and production links, and facilitates the declaration and commercialization process of related preparations.