On Dec 30, 2020, the National Health Commission (NHC) announced the list of second batch of encouraged generic drugs, including 19 drugs in which patents are about to expire in 2021 and 2022. The list is selected collectively by the National Health Commission (NHC), Ministry of Science and Technology (MOST), Ministry of Industry and Information Technology (MIIT), National Healthcare Security Administration (NHSA), China National Intellectual Property Administration (CNIPA), and National Medical Products Administration (NMPA). NHC is openly circulating for comments for the list from industries until Jan 7, 2021.
Specific information about the drugs is as follows:
List of Second Batch of Suggested Generic Drugs
|SN||Drug Name||Dosage Form||Strength|
|2||Fluticasone Furoate and Vilanterol Trifenatate||Powder for Inhalation||0.1mg Fluticasone, 25μg Vilanterol|
|3||Fluticasone Furoate, Umeclidinium Bromide and Vilanterol Trifenatate||Powder for Inhalation||0.1mg Fluticasone, 62.5μg Umeclidinium Bromide, 25μg Vilanterol; 0.2mg Fluticasone, 62.5μg Umeclidinium Bromide, 25μg Vilanterol|
|4||Clevidipine||Emulsions for Injection||50ml:25mg, 100ml:50mg|
|7||Mirabegron||Sustained-release Tablets||25mg, 50mg|
|13||Brivaracetam||Tablets||10mg, 25mg, 50mg|
|14||Desvenlafaxine||Sustained-release Tablets||25mg, 50mg, 100mg|
|16||Tapentadol||Sustained-release Tablets||50mg, 100mg|
|17||Brimonidine Tartrate and Timolol Maleate||Eye Drops||0.2% Brimonidine Tartrate, 0.5% Timolol Maleate|
The list of First Batch of Encouraged Generic Drugs was issued for the first time on June 20, 2019 and it was later officially published on September 17, 2019. The first batch included 33 drugs. Besides some domestic drugs whose patents had already expired or were close to expiration, the list also included, as recognized by the Chinese officials, those that were in short clinical supply and those with insufficient market competition. The indications of the drugs covered Behcet’s disease, tuberous sclerosis, myasthenia gravis and etc. In the official announcement, it was indicated that the government encouraged relevant enterprises in the industry to develop and produce the drugs in the list. In turn, the government would provide assistance in areas like clinical trials and technical research, and also grant priority status during the review and approval procedure.