[category] levetiracetam, the world's best-selling antiepileptic drug: Breakthrough of domestic market and local power

Source: among the best-selling antiepileptic drugs in the world, levetiracetam ("kepram"), as a broad-spectrum antiepileptic drug, has become a first-line drug due to its advantages of being able to treat epilepsy alone, not interacting with other antiepileptic drugs and good tolerance In early August 2015, FDA approved the launch of the world's first 3D printing drug spritam (levetiracetam) instant tablets, which means that 3D printing technology will further advance to the pharmaceutical field after printing human organs The 3D printing technology of changing the way of patients taking medicine appeared in the 1980s, which is actually the latest rapid prototyping device using the technology of light curing and paper lamination This technology has been considered to be able to change various fields Aprecia said: by combining 3D printing technology with highly prescriptive epilepsy treatment, spritam aims to meet the needs of patients whose medication is not convenient This is the first in a series of central nervous system products in the aprecia program to change the way patients take drugs In addition to the above epilepsy treatment drugs, aprecia also plans to launch a series of drugs, mainly in the fields of anti depression, schizophrenia or Parkinson's disease After acquiring the application of MIT 3D printing technology in medicine, aprecia developed a technology platform named zipdose, and prepared spritam tablets layer by layer in the mode of 3D printing Because spritam, a drug product made by 3D printing technology, has porous interior, high internal surface area, hydrophilic material on the surface of the product, and the tablet with a dose of up to 1000 mg can be quickly melted by water in a short time Compared with traditional medicine, the biggest advantage is that patients with dysphagia can take better medicine The best-selling epilepsy drug levetiracetam leads epilepsy as a long-term, chronic brain disease In recent years, due to the influence of patent cliff, the global market scale of antiepileptic prescription drugs is declining Among the best-selling antiepileptic drugs in the world, levetiracetam, as a broad-spectrum antiepileptic drug, is still the leading role in the global antiepileptic market At present, as the third generation of antiepileptic drugs continue to appear on the market, there will be more options for epilepsy treatment According to the statistics of the world's best-selling drugs, currently the world's best-selling antiepileptic drugs mainly include levetiracetam, lamotrigine, gabapentin, valproic acid, topiramate, carbamazepine, oxcarbazepine, phenobarbital, etc In 2013, the sales of the top three products of levetiracetam, lamotrigine and gabapentin exceeded US $1 billion, with sales of US $1.77 billion, US $1.42 billion and US $1.31 billion respectively; the products with sales of more than US $500 million included valproic acid, topiramate, carbamazepine and oxcarbazepine, with sales of US $940 million, US $720 million, US $650 million and US $53 million respectively Billion dollars The growth rate of these best-selling drugs is stable At present, the focus of research and development of antiepileptic drugs in the international market mainly focuses on high efficiency, low risk and low side effects Recently, the new generation of antiepileptic drug briviact (brivaracetam) of UCB company was approved by CHMP of EMA It is recommended that it be approved for partial seizures in adults and adolescents aged 16 and above, with or without secondary systemic seizures Buvasitan is a new antiepileptic drug launched by zuelacetan ("Kaplan") of Belgium UCB company after encountering patent cliff Buvasitan's good pharmacological activity, clinical efficacy and safety are expected to become another heavyweight antiepileptic drug after zuelacetan According to the statistics of domestic sample hospitals, the market scale of domestic anti epileptic drugs increased from 84.66 million yuan in 2005 to 718 million yuan in 2014, with a compound growth rate of 26.8% in 2005-2014 From the perspective of the overall market, the domestic market of antiepileptic drugs is mainly monopolized by import enterprises At present, the market of antiepileptic drugs in domestic sample hospitals is mainly occupied by the brands of zoelacetan ("Kaplan") of United Chemical Group (Belgium), oxcarbazepine ("qulai") of Novartis, sodium valproate ("debarkin") of Sanofi, lamotrigine ("libitun") of GlaxoSmithKline, etc., with strong foreign enterprises In 2014, the sales volume of the top three products in the field of anti epilepsy was over 100 million yuan, which can be said to be a large variety of small products, while the product with the fastest growth rate was levetiracetam, which increased by 36.5% compared with the same period in 2014, with the trend of competing for the top of anti epilepsy drugs Levetiracetam was first marketed in the United States in 1999, initially used in adult partial epilepsy; its solution was approved for marketing in July 2003; its injection was approved for marketing in July 2006; its sustained-release tablets were approved for marketing in September 2008 The drug has been widely recognized as the "gold standard" for the global treatment of epilepsy With the expiration of the global patent for levetiracetam, domestic enterprises have been involved In June 2014, the products of Shenzhen xinlitai Pharmaceutical Co., Ltd., Zhejiang Jingxin Pharmaceutical Co., Ltd and Chongqing shenghuaxi Pharmaceutical Co., Ltd were approved at the same time Then, the products of Zhuhai United Pharmaceutical Co., Ltd were approved in may 2015 So far, four domestic enterprises have been approved for production Until now, zuelacetan has been monopolized by Belgium UCB company With the continuous involvement of domestic enterprises, the market competition will be increasingly fierce According to data statistics of domestic sample hospitals, from 2007 to 2014, levetiracetam maintained a rapid growth rate Since 2011, the sales volume of the product in the field of antiepileptic drugs has risen to the second place, with a compound annual growth rate of 49.3% from 2008 to 2014 Levetiracetam has great variety potential and has a broad market prospect in China Since the second half of 2014, Chongqing shenghuaxi Pharmaceutical Co., Ltd has challenged the original drug levetiracetam in the sample hospital; in 2015, products of Zhejiang Jingxin Pharmaceutical Co., Ltd have also been added to the sample hospital for sale However, after all, the above two enterprises have entered the market and their sales volume is still small Levetiracetam is the only antiepileptic drug that can prevent epilepsy There is a huge space for import substitution, and there is a large growth space in the domestic market in the future.