Dapoxetine Hydrochloride Tablets And Cinacalcet Hydrochloride Tablets Were First Approved

- May 17, 2020-

On April 15, according to the NMPA official website drug approval notice, Huabo Kaisheng and Jiayi Pharmaceutical are expected to take the first imitation of dapoxetine hydrochloride tablets and cinacalcet hydrochloride tablets, respectively.


About Dapoxetine

Dapoxetine is a short-acting selective serotonin reuptake inhibitor that was initially used for analgesic and antidepressant, and was later developed to treat premature ejaculation (PE).


PE is a common male sexual dysfunction. According to foreign reports, the prevalence of PE in men aged 18 to 59 years is as high as 31%. Domestic scholars surveyed the incidence of FE up to 25.8%. However, the consultation rate of the disease is not high. The current domestic PE therapeutics mainly include tadalafil, sildenafil, dapoxetine, apomorphine and vardenafil, of which tadalafil and sildenafil have the largest market shares, accounting for about 90% market share.


However, since the original research dapoxetine was officially sold in China in 2013, its sales and market share have grown rapidly, and the "Chinese Expert Consensus on PE Diagnosis and Treatment" is recommended as a first-line treatment drug for PE.


In view of the huge market for PE, many domestic companies have deployed in this field. In the Dapoxetine market, Columbine Pharmaceuticals is the first domestic enterprise that has passed bioequivalence (BE) and applied for production in accordance with the original research quality consistency standard. However, from the current review and approval progress, Huabo Kaisheng Has successfully surpassed Columbine, and is expected to become the first company to win Dapoxetine.

In addition, according to the insight database, in addition to the two companies mentioned above, three companies have submitted listing applications. It is reported that the indication patent CN1387432A of dapoxetine in China originally expired in 2019, but it was invalidated in 2016, which means that the company can be listed and sold once it has obtained the qualification of generic drugs.


At present, the price of the original researched dapoxetine single tablet (30mg) is 65-75 yuan, and the pricing of generic drugs will generally be significantly lower than that of the original research. It is expected that the future of dapoxetine generic drugs is expected to create sildenafil generic drugs with price advantages Brilliant.


About Sina Case

Cinacalcet's original drug is a calcium-like agent originally developed by NPS Pharmaceuticals, and then licensed to Anjin and Xiehe Fermentation Kirin Pharmaceutical. The drug reduces the levels of parathyroid hormone, calcium, phosphorus, and calcium-phosphorus products by enhancing the sensitivity of calcium-sensitive receptors to calcium levels in the bloodstream. Currently approved indications include chronic kidney disease (CKD) maintenance dialysis Hypercalcemia in patients with secondary hyperparathyroidism (SHPT), patients with parathyroid adenocarcinoma, and patients with primary hyperparathyroidism.


The trade name and indication of this medicine are different in different countries or regions. The trade name in the United States is Sensipar (2004.03), the trade name in the European Union is Mimpara (2004.12), and the trade name in Japan is Regpara (2015.06). The trade name is Gaiping (2014.06). However, the drug is only approved for the treatment of SHPT in patients with CKD maintenance dialysis in Japan and China.


Since the listing, Sina Kasai's sales have increased year by year. In 2015, sales exceeded 1 billion US dollars. In 2018, sales in Europe and the United States reached a peak of about 1.774 billion US dollars. In 2019, the sales of original research Sinacaser showed a cliff-like decline, mainly because the core patent US6011068 of Sinacaser expired on March 8, 2018, and then a number of generic drugs were approved for listing.


In China, Sina Kasai was included in the national medical insurance catalog the second year after approval. With the increase in medical insurance, the sales of Gaiping in public hospitals in key provinces and cities in China have grown rapidly. Sales in the first half of 2019 reached 21.52 million yuan , Slightly lower than full-year sales in 2018. Moreover, Gai Ping successfully renewed the medical insurance for 2019. According to the insight database, the price of each tablet (25mg) is 34.55 yuan / 34.61 yuan, which is not cheap for a family of chronic kidney disease patients who need dialysis for a long time.


In view of Gaiping's excellent market performance, many domestic companies want to share a slice of the soup. At present, a total of 5 companies have submitted listing applications for 4 generic drugs of cinacalcet hydrochloride, of which Jiayi Pharmaceuticals submitted the first listing application and was included Priority review procedures.