Is tucatinib patented?

Tucatinib (tucatinib) is a drug developed by Seattle Genetics. According to current information, tucatinib has been granted patent protection. It is sold under the trade name TUKYSA. It is commonly available in two forms: oral 50 mg and 150 mg film-coated tablets. After a single oral dose of tucatinib in 11 subjects following a high-fat meal (approximately 58% fat, 26% carbohydrate, and 16% protein), the mean AUC0-INF increased by 1.5-fold, Tmax changed from 1.5 hours to 4 hours, and Cmax did not change. The effect of food on the pharmacokinetics of tucatinib is not clinically significant.

Across the dose range of 50 mg to 300 mg, tucatinib AUC0-INF and Cmax increased proportionally (0.17 to 1 times the approved recommended dose). The time to reach steady state is approximately 4 days. Steady-state pharmacokinetic parameters in patients with mBC and mCRC treated with tucatinib 300 mg twice daily for 7 days, the geometric mean (CV%) of the cumulative ratio of tucatinib AUC ranged from 2.0 (26) times to 2.5 (28) times.

It is understood that the original drug Tucatinib has not yet been launched in China, so it has not entered the scope of domestic medical insurance. Patients in need cannot yet purchase this drug in pharmacies or hospitals. The price of the European version of tucatinib original drug specifications150mg*60 tablets per box listed overseas is around RMB 72,000 (the price may fluctuate due to exchange rates), which is expensive. There are also generic drugs of Tucatinib produced in other countries. The price of 150mg*60 tablets per box produced by Laos pharmaceutical factory is around 6,400 RMB (the price may fluctuate due to the exchange rate). The price is much cheaper than the original drug, and the ingredients of foreign generic drugs are basically the same as the original drug.