First Domestic Quetiapine Fumarate Extended-Release Tablet Set to Challenge AstraZeneca's $260M Market

Recently, the review status of Foshan Derico Pharmaceutical’s quetiapine fumarate extended-release tablets was updated to “Under Approval.” According to data from Menet, sales of quetiapine fumarate at public medical institutions in China reached RMB 1.755 billion in 2018, representing a year-on-year increase of 32.13%. Currently, three pharmaceutical companies hold production approvals for quetiapine fumarate immediate-release tablets in the domestic market, while only the originator, AstraZeneca, holds the production approval for quetiapine fumarate extended-release tablets. Foshan Derico Pharmaceutical’s product is poised to become the first approved generic version.

Quetiapine Fumarate is a novel antipsychotic drug that acts as an antagonist of multiple neurotransmitter receptors in the brain. It is indicated for the treatment of schizophrenia, manic episodes associated with Bipolar I Disorder, bipolar disorder, and depressive episodes. This medication was developed by AstraZeneca and initially received FDA approval for marketing on September 26, 1997. Subsequently, it was approved for marketing by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on December 12, 2000.

Figure: Sales of Quetiapine Fumarate at Public Medical Institution Terminals in China, 2013–2018 (Unit: 10,000 Yuan)

(Source: Competitive Landscape of China's Public Medical Institutions Terminal, Menet Network)

According to data from Menet, in recent years, the sales of quetiapine fumarate in public medical institutions in China have increased year by year. In 2018, the sales reached RMB 1.755 billion, representing a year-on-year growth of 32.13%. Currently, the quetiapine fumarate available on the domestic market is mainly in tablet form, including immediate-release tablets and extended-release tablets.

Three pharmaceutical companies hold production approvals for quetiapine fumarate tablets: the originator AstraZeneca, and the generic manufacturers Hunan Dongting Pharmaceutical and Suzhou No.1 Pharmaceutical. Both generic manufacturers have submitted applications for consistency evaluation, with Hunan Dongting Pharmaceutical having already received approval. Currently, only the originator AstraZeneca holds the production approval for quetiapine fumarate extended-release tablets, and no generic products have been approved for marketing in the domestic market.

Table: Quetiapine Fumarate Extended-Release Tablets Filed for Market Approval as Generic Drugs under Category 4

(Source: MENET MED China Drug Evaluation Database 2.0)

Currently, there are more than 30 acceptance numbers for generic quetiapine fumarate extended-release tablets reported for production in the domestic market. Among them, 13 acceptance numbers were submitted for marketing approval under Category 4 of generic drugs, involving four companies: Beijing Tianheng Pharmaceutical Research Institute Nanyang Tianheng Pharmaceutical Factory, Shanghai Xuantai Haimen Pharmaceutical, Nantong Lianya Pharmaceutical, and Foshan Deruico Pharmaceutical. Foshan Deruico Pharmaceutical is progressing the fastest and is expected to become the first approved generic drug.

Source: Menet Database

Note: Data statistics are as of August 12. Any omissions are welcome to be corrected!