Bulong Pharmaceuticals Submits ANDA for Pregabalin Capsules as Over 10 Chinese Firms Enter the Market

Recently, the CDE official website showed that the Pregabalin Capsules submitted by Shandong Danhong Pharmaceutical | Shandong Buchang Pharmaceuticals for marketing application as a Category 4 generic drug have been accepted. Data from Menet shows that the sales of Pregabalin Capsules in China's urban physical pharmacies exceeded 100 million yuan in 2020, and it is expected to reach a new high in 2021. Notably, this product ranks as the TOP2 analgesic in China's urban physical pharmacy terminals.

Data show that pregabalin capsules are mainly used to treat postherpetic neuralgia and fibromyalgia. The product was developed by Pfizer and was approved for marketing in the UK in 2004.

Sales of Pregabalin Capsules in China's Urban Physical Pharmacies in Recent Years (Unit: Billion Yuan)

Source: MiNei Network's Competitive Landscape of Physical Pharmacies in Chinese Cities

Data from the MiNe Network shows that in 2020, sales of Pregabalin Capsules at retail pharmacies in Chinese cities exceeded 100 million yuan, and it is expected to reach a new high in 2021. Among them, Pfizer has the largest market share, accounting for over 80%.

Top 5 Pain Relief Products in China's Urban Physical Pharmacies 2021E

Source: MiNei Network's Competitive Landscape of Physical Pharmacies in Chinese Cities

Notably, Pregabalin Capsules are the second-best-selling pain relief medication in China's urban physical pharmacies.

Currently, there are 10 manufacturers of pregabalin capsules, among which 8, including Qilu Pharmaceutical (Hainan), China Resources Double-Crane Pharmaceutical, and Shijiazhuang Longze Pharmaceutical, have already passed the evaluation. Additionally, more than 10 companies, such as Sichuan Pharmaceutical Formulation, TianDi Hengyi Pharmaceutical, and Yabao Pharmaceutical Taiyuan, have submitted their applications for market approval, which are currently under review.

Source: CDE official website, MiNeiNet database

Note: The Menni Network's China Urban Physical Pharmacy Terminal Competitive Landscape Database covers physical pharmacies in 293 cities and above (excluding physical pharmacies in counties, villages, and towns) across China. It provides continuous monitoring of all product categories and is an expanded version of the urban physical pharmacy database. The aforementioned sales are calculated based on the average retail price of products at the terminal.