Qilu Pharmaceutical's Sildenafil Citrate Tablets Nearing Approval, Set to Enter China's Third-Phase Volume-Based Procurement

Recently, the application status of Qilu Pharmaceutical’s sildenafil citrate tablets, submitted under Category 4 generic drug registration, has been updated to “under review.” The product is expected to be approved in the near future and will be deemed as having passed the consistency evaluation. Sildenafil citrate tablets are included in the third batch of national centralized volume-based procurement. According to data from Menet, sales of sildenafil at urban retail pharmacies in China exceeded RMB 2.3 billion in 2019, representing a year-on-year increase of 7.42%.

Drug Registration Status

Sildenafil Citrate Tablets are indicated for the treatment of erectile dysfunction (ED) and function as a selective phosphodiesterase type 5 (PDE-5) inhibitor. PDE-5 inhibitors constitute the primary class of therapeutic agents for ED, with sildenafil, tadalafil, and vardenafil being the three most predominant PDE-5 inhibitors in the global market.

Data from Menet shows that in 2019, sales of sildenafil at China's urban retail pharmacy terminals exceeded RMB 2.3 billion, representing a year-on-year increase of 7.42%. Among them, Guangzhou Baiyunshan Pharmaceutical General Factory ranked first in market share, followed closely by the originator manufacturer, Pfizer.

Sildenafil Sales at Urban Retail Pharmacy Terminals in China (Unit: 10,000 Yuan)

Currently, the sildenafil formulations marketed in China include conventional tablets and orally disintegrating tablets. Among these, only the originator company, Pfizer, has received approval for sildenafil citrate orally disintegrating tablets. There are six manufacturers approved for sildenafil citrate tablets: Pfizer, Baiyunshan, Yabang Aipusen, Dihao Pharmaceutical, Jinheng Pharmaceutical, and Changshan Pharmaceutical.

Sildenafil Citrate Tablets are included in the third batch of centralized procurement varieties. Data from Menet’s Consistency Evaluation Database shows that the Sildenafil Citrate Tablets manufactured by Baiyunshan and Yibang Aipusen have passed the consistency evaluation. The registration status of Qilu Pharmaceutical’s Sildenafil Citrate Tablets has been updated to “under review.” If approved smoothly, it will be deemed as having passed the consistency evaluation, thereby securing eligibility for centralized procurement.

Source: Menet Database

[Market] Qilu to Secure Over RMB 2 Billion Anti-ED Drug