On Mar. 15, 2021, China announced the Second Batch of Encouraged Generic Drugs, with 17 medicines listed, including Arformoterol and Clevidipine.1
The list was jointly formulated by six government departments, including the National Health Commission (NHC), which organized an expert team to select the medicines whose patents are about to expire but have not applied for new registration. The selected drugs are also in short supply for clinical treatment with very limited providers on the market.
Compared to its draft version released in Dec. 2020, the list has removed brimonidine tartrate and timolol maleate ophthalmic solutions and olaparib tablets. It has also excluded brivaracetam tablets but keeps the drug's oral solution and injection forms.
The list contains seven drugs for nervous system, three drugs for respiratory system, two drugs for gastrointestinal and hepatobiliary system, one anti-neoplastic drug, one drug for urinary and reproductive system, one drug for cardiovascular system, one analgesic, and one diagnostic agent for endocrine and metabolic disorders.
Details of the Second Batch of Encouraged Generic Drugs
SN | Drug Name | Dosage Form | Strength |
1 | Arformoterol | Inhalation Solutions | 2ml: 15μg |
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 Umetium Bromide, 25μg Vilanterol, 0.2mg Fluticasone, 62.5μg Umetium Bromide, 25g Vilanterol |
4 | Clevidipine | Emulsions for Injection | 50ml: 25mg, 100ml: 50mg |
5 | Obeticholic acid | Tablets | 5mg |
6 | Plecanatide | Tablets | 3mg |
7 | Mirabegron | Sustained-Release Tablets | 25mg, 50mg |
8 | Elagolix | Tablets | 150mg, 200mg |
9 | Eliglustat | Capsules | 84mg |
10 | Macimorelin | Oral Solutions | 120ml: 60mg |
11 | Eslicarbazepine | Tablets | 200mg, 400mg |
12 | Perampanel | Tablets | 2mg, 4mg |
Oral Suspensions | 0.5mg/ml | ||
13 | Brivaracetam | Oral Solutions | 10mg/ml |
Injections | 5ml: 50mg | ||
14 | Desvenlafaxine | Sustained-Release Tablets | 25mg, 50mg, 100mg |
15 | Tasimelteon | Capsules | 20mg |
16 | Tapentadol | Sustained-Release Tablets | 50mg, 100mg |
17 | Cabazitaxel | Injections | 1.5ml: 60mg |
These drugs could benefit from preferential policy support in terms of review and approval, clinical trials and critical generic technology researches in China. They are also more likely to enter the centralized procurement list after passing the quality and efficacy consistency evaluation.
For more information on China's generic drug policies, welcome to consult BaiPharm through info@baipharm.com.
