What Are The Top Selling Generic Drugs In 2018?

A generic drug is a drug with thesame active ingredients, dosage form, route of administration and therapeuticeffect as the original drug. In clinical practice, it can be replaced with theoriginal research drug, which is beneficial to save the medical expenses of thesociety. Here are some of the top selling generic drugs and manufacturers in 2018.

Ticagrelor Tablets

AstraZeneca's ticagrelor is thefirst triazolo[4,5-D]pyrimidine anti-platelet aggregation drug, which wasapproved by the US FDA in July 2011 and imported into China in November 2012.Compared with its main competitor, clopidogrel, ticagrelor does not requireliver metabolic activation and has the characteristics of faster and morepotent platelet inhibition, so it is considered to be one of the top sellinggeneric drugs. At the same time, ticagrelor has been recommended by manyEuropean and American guidelines as the preferred or first-line antiplateletdrug for patients with ACS. Ticagrelor was included in the Chinese MedicalInsurance Drug List in 2017. AstraZeneca also provides ticagrelor free ofcharge to newly diagnosed ACS patients in domestic chest pain centers,prompting ticagrelor to be the first choice for the diagnosis and treatment of ACS patients in the cardiovascular medicine departments of major domestichospitals. In 2017, Xinlitai successfully challenged the original researchpatent of ticagrelor. In January 2018, the patent of AstraZeneca ticagrelor wasdeclared invalid, and the original ticagrelor compound expired on December 2,2019. On August 3, 2018, Xinlitai released an announcement that ticagrelortablets had obtained drug registration approval, and as a new category 4application, ticagrelor tablets were also deemed to have passed the consistencyevaluation. It is not clear for the time being that after the successful patentchallenge, the State Bureau has any registration time threshold for Xinlitai torestrict other top selling generic drugs. Since February 2018, ticagrelor hasreceived 14 acceptance numbers, making it the most popular imitation product inthe first three quarters.

Entecavir tablets

Although Jiangxi Qingfeng'sentecavir capsules and entecavir dispersible tablets and Chia Tai Tianqing'sentecavir dispersible tablets passed the consistency evaluation in 2018, theoriginal entecavir tablet has not yet been marketed as the first generic drug.Guangdong Dongguang Sunshine and Zhejiang Huahai both received priority reviewfor their production co-line double-span declarations. The "Four PlusSeven" draft on the pilot cities for centralized procurement that haspassed the consistency evaluation recently circulated on the Internet mentionedthat all solid preparations are regarded as the same group of bidding procurement.The price advantage that the first generic entecavir tablet can obtain isexpected to be greatly reduced.

Celecoxib Capsules

The patent of Pfizer's celecoxibcapsule has expired, but no domestic generic drug manufacturer has listed it.After the first imitation of parecoxib sodium for injection was snatched byKelun in 2017, Qilu and Jiangsu Osaikang were subsequently approved forproduction in 2018. It is not known whether celecoxib capsules will be approvedby 3 generic drug manufacturers within 2 years like parecoxib sodium for injection. Jiangsu Hengrui and Jiangsu Zhengda Qingjiang received priorityreview on the grounds that "the applicant voluntarily withdraws andre-applied the registration application of generic drugs after improvement accordingto the standards consistent with the quality and efficacy of the originaldrug". The double-span declaration of production collinearity is givenpriority review. Jiangsu Hengrui and Jiangsu Zhengda Qingjiang have entered theclinical self-inspection and verification catalogue and entered the announcement of the on-site verification of drug clinical trial data. There arealready successful cases of double-cross products that can be reported to the factory without checking clinical trials, so it is hard to say which one is thefirst copy to be listed.

Tadalafil tablets

Viagra Cidanafil is one of the top sellinggeneric drugs, with sales expected to exceed 2.5 billion yuan in 2018. Thefirst generic competition of tadalafil tablets has also attracted much attention.Qilu Pharmaceutical (Hainan) was granted priority review for the double-spanapplication in the production line, while Changchun Haiyue applied for drugproduction one year before the patent expired. Changchun Haiyue, QiluPharmaceutical (Hainan), Nanjing Chia Tai Tianqing, Wuhan Renfu, Jiangsu TaslyDiyi, and Zhejiang Yongning have all entered the clinical self-inspection andverification directory, but only Changchun Haiyue has entered the drug clinicaltrial data on-site verification plan announcement.

Erlotinib hydrochloride tablets

Erlotinib hydrochloride tablets ofRoche entered the medical insurance negotiation catalog in 2017, and the pricewas reduced by 66% to enter the medical insurance, with a price of 195 yuan(150mg/tablet). Announcement on the on-site verification plan of clinical trialdata of drugs that received priority review and entered the clinicalself-inspection and verification catalogue. It is expected that Shanghai Acronowill obtain the first imitation qualification after the patent expires.

The top selling generic drugs in2018 are all products with a sales potential of over 100 million. Since 2018,the production of generic drugs has basically been declared according to thenew 4 categories, and the above popular products have been declared by morethan 4 domestic manufacturers. Whether the first-to-market drug manufacturerscan gain a greater competitive advantage in the market remains to be seen.