The original research patent expires without price reduction, and the spring of domestic pulmonary hypertension generic drugs is coming!

Pulmonary hypertension (PH) is a kind of pulmonary vascular disease that can not be cured completely at present, and it also needs to be taken for life Before that, bosentan tablet was the main drug for pH treatment in China Although the patent of the drug has expired, it still refused to reduce to the negotiated price in the first half of 2017 in the national health insurance catalog negotiation varieties The original research refused to reduce the price, and the spring of domestic generic drugs has come PH is a rare disease with an average incidence rate of 0.2/ per one hundred thousand people worldwide The main symptoms were asthenia, exertional dyspnea, occasionally chest discomfort and syncope Most cases are secondary, that is, caused by other diseases such as chronic pulmonary disease, pulmonary vascular thrombosis, and a few are idiopathic, that is, only pulmonary hypertension occurs, and the cause is unknown In most patients, pH eventually leads to right ventricular hypertrophy, dilation, and right ventricular failure There is no complete statistical data of pH patients in China, but it is underestimated compared with developed countries The main characteristics of pH are reversible vasoconstriction, hypertrophy of smooth muscle and remodeling of blood vessel wall Part of the reason for vasoconstriction is the increased activity of thromboxane and endothelin-1 (both vasoconstrictors), and the decreased activity of prostacyclin and nitric oxide (both vasodilators) At present, the main types of clinical medication are related to these three mechanisms Pulmonary hypertension vasoconstriction pathological pathway endothelium receptor antagonist note: click the picture to see a clear picture The time difference between the three drugs in the United States is about 5 years With the improvement of safety and convenience, bosentan is no longer the first choice for new patients However, the current comparative clinical trials are only among the same kind of drugs, and have not been carried out in the comparative study of other types of pulmonary hypertension drugs Note to phosphodiesterase 5 inhibitor: click the picture to see a clear picture Because phosphodiesterase 5 inhibitor can not be used with soluble guanosine cyclase activator, it may be used with endothelium receptor antagonist to expand the market in patients with severe pulmonary hypertension, but the contribution of pulmonary hypertension to the market sales of PDE5 inhibitor is still small Note of soluble guanosine cyclase activator: click the picture to see the clear big picture Note of cyclic prostaglandin derivatives: click the picture to see the clear big picture Common adverse reactions of cyclic prostaglandin derivatives are flushing, cough, headache, insomnia, nausea, hypotension, vomiting, etc Note: click the picture to see a clear picture In 2016, skin receptor antagonists accounted for half of the market share of pulmonary hypertension, reaching US $1.7 billion For the rare disease whose mechanism is not clear, the drugs on the market can only delay the progress of the disease, but also optimize the safety and pharmacokinetics, and there is no breakthrough in the mechanism With the expiration of patent of bosentan and other drugs, generic drugs can quickly occupy a certain market share, which will reduce the burden of patients with pulmonary hypertension to a certain extent.