Generic drugs: "3 + 1" becomes "4 + 1", and ED market adds another member

Original: dopine At present, the status of listing application of tadalafei tablet of Jiangsu tiansiliyi Pharmaceutical Co., Ltd in nmpa is "certificate preparation pending approval" However, it is reported that Jiangsu tiansiliyi Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Jiangsu tiansiliyi Pharmaceutical Co., Ltd., has received the drug registration approval on tadalafei tablet approved and issued by the State Food and drug administration, which means that the domestic tadalafei market will be from the original "1 original research + 3 The situation of "home imitation" has changed to "1 original research + 4 imitations" Tadalafil, a long-acting selective phosphodiesterase 5 (PDE5) inhibitor developed by Lilly, was first approved for the treatment of male erectile dysfunction (ED), but later approved by FDA for the treatment of pulmonary hypertension (PAH) (2009) and benign prostatic hyperplasia (BPH) (2011) Tadalafil was approved by EMA in 2002, FDA in 2003, and entered the domestic market in 2005 And in June 2007 and January 2008, tadalafil was successively approved as "once daily use" dosage form in Europe and the United States, opening a new mode of ED treatment: a breakthrough from the traditional mode of taking on demand to a more personalized treatment mode, and an upgrade from "physiological function improvement" to "both physical and mental" However, the "once daily use" dosage form of tadalafil was launched late in China, and only in 2013 As the first long-acting PDE5 inhibitor in the world, tadalafil has been recommended as the first-line treatment drug for ed by medical guidelines of many countries and regions Since its launch, its sales have increased year by year, and it has become a heavyweight product of Lilly However, before 2013, the sales volume of tadalafil was not as good as that of sildenafil (trade name: Viagra), but since then, it has been surpassing sildenafil To explore the reasons, not only because of its fast onset, long duration of action, absorption not affected by food, but also because of the introduction of "once daily use" dosage form In China, before that, tadalafei market belonged to the situation of "1 original research + 3 imitations" (see the table below) Among them, Changchun Haiyue took the lead in taking tadalafei's first imitations in February 2019, followed by Nanjing Zhengda Tianqing and Qilu However, since the approval of terafil, the domestic market of terafil will become "1 original research + 4 imitations" According to insight database, Lilly, Qilu and Changchun Haiyue tadalafei have won the bidding in some areas In addition, in China, in addition to the four approved domestic enterprises, according to insight database, there are more than 40 domestic enterprises in the field of layout, more than 30 of which are tablets, 3 are oral instant film agents, and 1 chewable tablet, so it can be predicted that the market competition in this field will be more intense in the future In fact, in addition to tadalafil, vardenafil and sildenafil mentioned above have been approved as PDE5 inhibitors for ED in China, among which sildenafil is the most prominent The original manufacturer of sildenafil is Pfizer, with the trade name of Viagra, which is often called "Viagra" It was first approved for listing in the United States in 1998 and entered the domestic market in 2001 Since then, it has almost monopolized the entire domestic ED market Until the listing of "Jinge" generic drug in Shanxi, Baiyun, in 2014, the growth rate of Viagra began to decline, but it is still China's ED market ED market of physical pharmacies in cities with sales volume of the largest And so far, according to insight database, many domestic enterprises have obtained the qualification of sildenafil generic drugs, more than a dozen enterprises are in the process of listing applications, and the future competition is very fierce Vardenafil's original manufacturer is Bayer, the trade name is Elida, which entered the market in 2003 Although Aida has the fastest time to take effect compared with Viagra and hilly, its post IPO report card is not bright In 2015, its global sales volume was only 226 million euros (about 264 million US dollars).