8 generic drug opportunities under the new "patent cliff"!

Source: pharmaceutical economic daily / fan Ping 2015-2-5 "drug life cycle" is a proper term in the European and American pharmaceutical market, which refers to the process of innovative drugs from research and development to introduction, growth, maturity and even decline From the peak of sales volume to the decline, the products come from the entry of a new generation of products, replacing the old ones; on the other hand, due to the expiration of patents, the entry of generic drugs leads to a significant reduction in drug prices Therefore, there is a period when a large number of heavy-duty product patents expire, known as the "patent cliff" era in the industry From 2011 to 2012, once known as the "patent cliff" era, the core patents of patent varieties with annual sales of nearly US $80 billion expire, and the heavyweight varieties include the antithrombotic drug clopidogrel, the Alzheimer's drug donepezil, the epilepsy drug gabapentin, COPD Montelukast, valsartan for hypertension, sertraline for antidepressant and docetaxel for tumor were used According to the analysis, the number and sales volume of innovative drugs that will expire in 2014-2015 are no less than that in 2011-2012 According to data released by FDA, patents for 619 drugs, including a large number of heavyweight varieties, will expire in 2014-2015 The expiration of patent drugs will undoubtedly bring opportunities to many domestic generic pharmaceutical manufacturers Previously, some domestic enterprises have used this opportunity to share a considerable part of the original drug market At the same time, the expiration of patent drugs also brings benefits to the medical insurance administration and patients Here, we will sort out some expired patent varieties and evaluate their generic pharmaceutical opportunities in China It should be noted that, unlike 2011-2012, many expired patent drugs belong to biological drugs, and the difficulty of their imitation is far greater than that of traditional chemical drugs Even if they are approved, biological generic drugs are not equal to patent drugs, and there are certain development risks "Drug life cycle" is a proper term in European and American pharmaceutical market, which refers to the process from research and development to introduction, growth, maturity and even decline of innovative drugs From the peak of sales volume to the decline, the products come from the entry of a new generation of products, replacing the old ones; on the other hand, due to the expiration of patents, the entry of generic drugs leads to a significant reduction in drug prices Therefore, there is a period when a large number of heavy-duty product patents expire, known as the "patent cliff" era in the industry From 2011 to 2012, once known as the "patent cliff" era, the core patents of patent varieties with annual sales of nearly US $80 billion expire, and the heavyweight varieties include the antithrombotic drug clopidogrel, the Alzheimer's drug donepezil, the epilepsy drug gabapentin, COPD Montelukast, valsartan for hypertension, sertraline for antidepressant and docetaxel for tumor were used According to the analysis, the number and sales volume of innovative drugs that will expire in 2014-2015 are no less than that in 2011-2012 According to data released by FDA, patents for 619 drugs, including a large number of heavyweight varieties, will expire in 2014-2015 The expiration of patent drugs will undoubtedly bring opportunities to many domestic generic pharmaceutical manufacturers Previously, some domestic enterprises have used this opportunity to share a considerable part of the original drug market At the same time, the expiration of patent drugs also brings benefits to the medical insurance administration and patients Here, we will sort out some expired patent varieties and evaluate their generic pharmaceutical opportunities in China It should be noted that, unlike 2011-2012, many expired patent drugs belong to biological drugs, and the difficulty of their imitation is far greater than that of traditional chemical drugs Even if they are approved, biological generic drugs are not equal to patent drugs, and there are certain development risks Eight focus varieties of new opportunities patent expired biopharmaceutical varieties are worthy of attention, but do not blindly follow the trend 1 Original research of insulin glargine: Laishi (Sanofi) generic pharmaceutical enterprises: six new opportunities: ★ among the varieties expired in 2014-2015, the most attracting industry attention is undoubtedly Sanofi's Laishi (insulin glargine) Insulin glargine is a long-acting insulin As long-acting insulin can reduce the frequency of administration and the risk of blood glucose fluctuation and hypoglycemia, insulin glargine has gradually become a first-line treatment drug for diabetes in Europe and the United States since its launch According to the financial report of the original research party, "Laishi" has become a heavy bomb category since 2004 Since then, the sales volume of the product has maintained a rapid growth, reaching $7589 million in 2013 Insulin glargine was introduced into the Chinese market by Sanofi in 2004 However, unlike the European and American market monopoly for more than ten years, Ganli pharmaceutical industry was approved to be listed as "changxiulin" of insulin glargine in 2005 Since then, due to patent factors, no enterprise has been approved to be listed as insulin glargine According to the sales data of sample hospitals of Pharmaceutical Association, the sales volume of insulin glargine reached 362 million yuan in 2013, which is the best-selling insulin product With the expiration of the patent, insulin glargine has attracted the attention of many pharmaceutical enterprises Compared with monoclonal antibodies, insulin drugs are not high in technical threshold, and the difficulty of imitation is relatively limited According to the data of CDE, at present, there are five enterprises, including federal pharmaceutical, Shandong new era pharmaceutical, Jiangsu Wanbang pharmaceutical, Zhejiang Haizheng pharmaceutical and Yichang Changjiang pharmaceutical, applying to copy the variety In terms of progress, some enterprises have completed clinical research and entered the production stage According to the market scale of insulin glargine and the trend that there will be a large number of oral diabetes patients to use or add long-term insulin in the future, there are not many 7 enterprises However, considering that long-term insulin is a long-term injection drug, patients have high requirements for product quality and brand, and the appeal of simple price factor is quite limited There is also a need to remind that at present, two varieties of insulin glargine have adopted the "injection pen" drug delivery mode New entrants to enter the "insulin glargine" market is not a simple matter of obtaining an injection approval 2 Aripiprazole's original research drug: about 10 new opportunities: among the super heavy bomb varieties with annual sales of more than 5 billion US dollars, aripiprazole undoubtedly belongs to a relatively low-key variety, which may be related to its main indication of schizophrenia However, according to IMS data, from July 2013 to June 2014, the drug with the highest sales volume in the United States was "aripiprazole" (aripiprazole), with sales volume reaching US $7.2 billion, surpassing the world's best-selling drug "sumerial" (with sales volume of US $6.3 billion) According to this data, the global sales of aripiprazole in 2014 is likely to exceed 7 billion US dollars Aripiprazole was first approved for sale in the United States in 2002, and its sales rights in North America and Europe were obtained by Bristol Myers Squibb The speed of aripiprazole's entry into China lags behind slightly In 2006, anrufan, the former researcher of Otsuka, entered China Before that, in 2004, Chengdu Kanghong and Shanghai Zhongxi's imitation of aripiprazole had been approved Since then, there have been three competitive markets in China In terms of sales volume, "bosiqing" of Chengdu Kanghong, the first listed company, temporarily takes the lead Although antipsychotic is a small field, the superior performance of aripiprazole in the European and American market still attracts many imitative enterprises According to CDE data, nearly ten enterprises, including Qilu, Enhua, Huahai, hausen and Tianjin HongRi, have entered the imitation state From the perspective of manufacturers, most of them are enterprises with a variety foundation in the spiritual field, which will undoubtedly increase the pressure of competition Unless new manufacturers have a better market foundation in this field, they will not succeed 3 Original research drug of esomeprazole: nexin (AstraZeneca) generic pharmaceutical company: dozens of new opportunities: ★ esomeprazole is an upgrade substitute of omeprazole developed by AstraZeneca Omeprazole, as the first PPI drug, has great clinical significance Its annual sales volume has been billions of dollars for a long time Esomeprazole is the left-handed isomer of omeprazole Compared with omeprazole, esomeprazole has stronger acid inhibition and faster effect At the same time, because it is not metabolized by CYP2C19 enzyme basically, it is suitable for patients with CYP2C19 enzyme metabolism abnormality Esomeprazole was first approved for listing in 2000, and its trade name is "Nexium" "Nexin" entered China in 2004 Because of its patent, it has a long-term exclusive right It was not until 2013 that Chongqing Laimei's imitated esomeprazole was approved for listing However, this product is different from the original drug, the original drug is esomeprazole magnesium salt, and the original drug is esomeprazole, although they are very similar, they are not the same In terms of sales volume, the original research drug still accounts for most of the share According to the sales data of sample hospitals in the first three quarters of 2014, the sales volume of "Nexium" reached 660 million yuan, and Laimei's products were only over 100000 yuan The short time to market is the main reason for the poor sales volume As the first imitated product, Laimei still has great opportunities The follow-up imitated varieties have also begun to follow up At present, dozens of enterprises have imitated, and the imitated drugs of some manufacturers are expected to be approved in 2015 In the future, with the centralized listing of imitated products, the market competition of esomeprazole will be very fierce, and subsequent manufacturers are not recommended to follow up 4 Original research drug of octreotide: Shanning (Novartis) generic pharmaceutical company: many new opportunities: ★ octreotide is a synthetic somatostatin octapeptide, whose function is similar to natural somatostatin The clinical application of octreotide is very extensive The main indications include the treatment of upper gastrointestinal vein rupture and bleeding, the treatment of gastric ulcer bleeding, acute pancreatitis, endocrine tumor of digestive system, etc Octreotide was developed by Novartis and was first approved for marketing in 1996 At that time, the approved indications were acromegaly, diarrhea and pancreatic cancer Octreotide has become one of the most concerned bio generic drugs due to its precise therapeutic effect and many indications The original research drug Novartis "Shanning" entered China in 2004 After it was approved, many domestic imitated varieties have been listed in succession At present, the sales volume of octreotide sample hospital is about 400 million yuan, of which the original research drug accounts for 2 / 3 of the total Among the generic drugs, Jilin Yixin Pharmaceutical Co., Ltd has a large share, while the other manufacturers have a limited share Although the market of octreotide is huge, there are many generic drugs and the advantages of the original brand are obvious, so it is difficult for new entrants 5 Original research drug of memantine: yibeishen (German Macintosh) generic pharmaceutical company: 11 new opportunities: ★★★★ memantine is an Alzheimer's drug developed by Macintosh pharmaceutical company in Germany It was first listed in the United States by Lingbei company in 2000 Memantine is the first dementia drug to act on NMDA and the first drug approved for severe Alzheimer's disease At present, memantine's global market is mainly awarded to forest pharmaceutical and the first three republics Lingbei, with annual global sales of US $2.25 billion Memantine entered China in 2006 As the only drug for severe Alzheimer's disease, the original research drug of memantine "Yi Bei Shen" is growing rapidly in the Chinese market According to the data of the Pharmaceutical Association, the sales volume of the sample hospitals reached 59 million yuan in the first three quarters of 2014, which has been compounded in the past five years