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On April 15, the country's first drug patent link litigation case was pronounced.
Earlier in July 2021, the State Drug Administration and the State Intellectual Property Office issued the "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes (Trial)", marking the implementation of the drug patent link system
The "Measures" stipulate that the first drug that challenges the patent and is approved for marketing can enjoy a one-year market exclusivity period, during which the drug regulatory department will not approve the marketing of the same variety of generic drugs
The first drug that challenges the patent and is approved for marketing can enjoy a one-year market exclusivity period, during which the drug regulatory authority will not approve the marketing of the same variety of generic drugs
Drugs with expiry time in 2021 and 2022 and no domestic products are currently on the market, 38 29
01.
01.
Table 1: Number of Patent Expiring Drugs and Distribution of Therapeutic Areas in 2021 and 2022
Source: New Drug Development Monitoring Database (CPM), China Pharmaceutical Industry Information Center
02.
02.
Table 2: (Partial) Potential Therapeutic Area/Generic Name Patent Expired Drugs
Market size forecast in 2025
Source: New Drug Development Monitoring Database (CPM), China Pharmaceutical Industry Information Center
03.
03.
1.
Figure 1: Market Performance of Digestive System Drugs in Sample Hospitals from 2012 to 2021
Source: Drug Comprehensive Database (PDB), China Pharmaceutical Industry Information Center
2.
2.
Figure 2: 2012-2021 Market Performance of Neurological Drugs in Sample Hospitals
Source: Drug Comprehensive Database (PDB), China Pharmaceutical Industry Information Center
3.
3.
Figure 3: Market performance of endocrine and metabolic regulation drugs in sample hospitals from 2012 to 2021
Source: Drug Comprehensive Database (PDB), China Pharmaceutical Industry Information Center
summary
summaryThe first generic drug has become an important direction for the transformation and upgrading of pharmaceutical companies
In the battle of speed and passion, for generic pharmaceutical companies, it is necessary to fully understand the core patent technology and expiration time of blockbuster drugs, track the progress of global research and development, and avoid patent disputes by adopting patent breakthroughs and patent evasion methods, and obtain potential therapeutic benefits.
A leading generic drug market position is critical
.
Only professional and efficient can win this race against time
.
