Beijing News (Reporter Wang Kala) — Recently, the Alprazolam Tablets produced by Jiangsu Nhwa Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd. passed the generic drug consistency evaluation on the same day. Data from Menet shows that in the 2022 market for chemical anti-anxiety drugs in China's public medical institutions, Alprazolam ranked as the fourth most significant product. Since 2013, the sales of Alprazolam Tablets have continued to rise, surpassing 100 million yuan in 2019 and exceeding 200 million yuan in 2022, indicating promising market potential.
The major drugs in the anti-anxiety medication market include Tandospirone, Buspirone, Lorazepam, Alprazolam, Oxazepam, Diazepam, Compound Diazepam, and Clobazam. PDB data shows that Tandospirone's sales exceed 40%, ranking first in market share; the market shares of Buspirone, Lorazepam, Alprazolam, and Oxazepam all surpass 10%, while the total market share of all other drugs is approximately 6%.
Alprazolam belongs to the benzodiazepine class of hypnotic, sedative, and anxiolytic drugs. It is mainly used for anxiety, tension, and agitation. It can also be used as an auxiliary medication for insomnia or anxiety and as an anti-panic drug. Additionally, it can alleviate acute alcohol withdrawal symptoms. It has been included in the "National Basic Medical Insurance Drug List (2022)." The original drug was first launched by Upjohn Company in 1981 and entered the Chinese market in the 1990s. According to data from the National Medical Products Administration, there are 57 approvals for alprazolam. Anxin Pharmaceutical, Qingyang Pharmaceutical, Xinyi Pharmaceutical, and Tianfang Pharmaceutical hold the raw material drug approvals, while the remaining 53 approvals are for formulations. Except for Heilongjiang Ruige Pharmaceutical's alprazolam capsules, all others are in tablet form.
In terms of the consistency evaluation of generic drugs, among the 53 formulations, the majority have seen no progress in their consistency evaluations. In 2020, Xinyi Pharmaceutical, under Shanghai Pharmaceuticals, became the first to pass the evaluation for Alprazolam. Jiangsu Nhwa Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd. have recently passed the evaluation for Alprazolam. The varieties produced by Beijing Yimin Pharmaceutical, Chongqing Qingyang Pharmaceutical, and Dongting Lake Pharmaceutical are reference listed drugs for record-filing. Tianfang Pharmaceutical also submitted a supplementary application this year, while the rest have shown no progress. According to disclosures from Jiangsu Nhwa Pharmaceutical, the R&D expenses invested in this variety amounted to approximately 6.64 million yuan. Additionally, according to previous announcements from Shanghai Pharmaceuticals, Xinyi Pharmaceutical invested 6.935 million yuan in R&D expenses for the consistency evaluation of this variety.
In terms of market competition, data from the MIR Net shows that in 2022, Jiangsu Nhwa Pharmaceutical Co., Ltd. ranked first in market share for this variety (28.71%), followed by Shandong Xinyi Pharmaceutical (24.62%) and Qilu Pharmaceutical (9.43%). All TOP3 have already "passed the evaluation."
Proofread by Baoqing Liu