Difficult generic drug Xinlitai "hydrochloric acid parositin intestinal dissolved release tablets" was first approved.

On August 13, Xinlitai Class 4 generic drug "Paroxetine hydrochloric acid intestinal solubility tablets" was approved by the State Drug Administration, successfully won the high-tech difficulty of intestinal solubility release agent type first imitation.
The Insight database review timeline shows that the species has completed clinical on-site verification and experienced a round of additional information, which lasts 681 days from the time the application for listing is submitted to the time it is currently approved.
paroxetine hydrochloride, a powerful selective 5-serotonin reuptake inhibitor (SSRI), is clinically widely used in various types of depressive disorders such as obsessive compulsive disorder, generalized anxiety disorder, and social phobia.
was originally researched by GlaxoSmithKline, first approved by the FDA in 1991, and has now been approved for general tablets and intestinally soluble tablets;
In China, paroxetine generic tablets were approved earlier, in 1995 was approved for import, there are currently Huahai, Beijing Fuyuan, Peak Pharmaceuticals generic drugs approved;
public data show that in 2019, the domestic public medical institutions antidepressant drug market size reached 7 billion yuan, of which paroxetine tablets in 2019 sales of about 680 million yuan, second only to Essiopram tablets and shertin tablets;
in the 2017 health care negotiations, the hydrochloric acid parostin intestinal dissolution tablets successfully entered the health insurance, after which significant volume, in 2018 public health facilities sales growth rate of 2429%, is expected to continue to maintain rapid growth in quality in the next few years.
It is known that oral administration of parositin hydrochloric acid has a certain stimulating effect on the stomach mucosa, easy to cause adverse reactions such as nausea in patients, and parositin intestinal solubility tablets are based on slow release tablets wrapped in a layer of intestinally soluble coating, so that the drug avoids Released in the stomach and slowly released in the small intestine, blood drug concentration fluctuations are small, more durable and safer than ordinary preparations, better compliance for patients, but double-layered intestinal dissolved release tablets on the preparation technology requirements are higher, the relevant in the study of generic drugs are also less.
Insight database shows that at present, in addition to Xinlitai, Shanghai Xuantai Haimen Pharmaceuticals in April this year submitted the listing application for intestinal solubility tablets, is currently in the new report task review, is expected to be approved as soon as next year Q2;
Images from: Insight Database () In the short term, the competition for generics of parostin intestinally soluble tablets is not fierce, and due to technical barriers and the advantages of health care payments, coupled with the clinical advantages of intestinally soluble tablets, generics are expected to quickly open up the market with low prices.
.