Trend analysis of ANDA after the implementation of the drug patent linkage system in China
- VernacularTitle:药品专利链接制度实施后我国仿制药申请态势分析
- Author:
Xuefang YAO
1
;
Yan ZHANG
1
Author Information
1. School of Health Economics and Management，Nanjing University of Chinese Medicine，Nanjing 210023，China
- Publication Type:Journal Article
- Keywords:
drug patent linkage system;
ANDA;
patent certifications;
trend analysis
- From:
China Pharmacy
2024;35(21):2577-2581
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide a reference for improving the drug patent linkage system. METHODS Data on drug names， drug types， abbreviated new drug application （ANDA） acceptance numbers， registration classifications， and applicant names were obtained from the patent certifications and patent information disclosure modules of China’s patent information registration platform for marketed drugs. The data collection period was from July 4， 2021， to September 30， 2023. The analysis focused on the annual distribution of patent certifications for the ANDA varieties included in the statistics， the proportion of different registration classifications， the details of the type Ⅳ certifications， the remaining validity periods of the corresponding patents for the type Ⅲ certifications， and the number of manufacturers for the same variety. RESULTS Among the ANDA varieties analyzed， type Ⅰ certifications predominated （accounting for 86.53%）， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for approximately 4% to 5%. In the three registration classifications， type Ⅰ certifications in registration classification 3 accounted for as high as 98.55%， and in registration classification 4， type Ⅰ certifications accounted for 79.65%， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for around 7%. In terms of the detailed type of the Ⅳ certifications， type Ⅳ of article 2 certifications had a large proportion （79.23%） and showed a slight upward trend， whereas the challenges of type Ⅳ of article 1 certifications were few. The remaining validity period of the patents corresponding to type Ⅲ certifications was excessively long， with a median of 18 months. The proportion of the same variety with fewer than 5 manufacturers was 36.44%， while those with more than or equal to 20 manufacturers accounted for 14.75%. CONCLUSIONS The ANDA system in China has been orderly integrated with the drug patent linkage system in practice. It is recommended to optimize aspects such as patent certifications registration and objection mechanisms， the effective approval dates for ANDA with type Ⅲ certifications， and incentive measures for type Ⅳ of article 1 certifications， thereby further standardizing the ANDA process and guiding the high-quality development of generic drugs.
