67 major varieties of patents expire, who will be the first to imitate?

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 new drug development monitoring database (CPM) of the China Pharmaceutical Industry Information Center was used for screening, and the "Approved Drug Products with Therapeutic Equivalence Evaluations" ("Approved Drug Products with Therapeutic Equivalence Evaluations", referred to as "Orange Book of American Drugs") was selected.

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

In the past two years, the market size of drugs that have expired in the past two years will exceed 10 billion US dollars in 2025

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

Compound growth rate up to 30%

1.
Potential therapeutic area 1: Digestive system drugs

Judging from the sales data of the national sample hospital drug market, the sales amount of digestive system drug sample hospitals in 2021 will be 19.
79 billion yuan; the compound growth rate from 2012 to 2021 will be 4.
5%, and the peak in 2019 has reached 21.
4 billion yuan.
In 2020 and 2021 Affected by the new crown epidemic in 2018, the sales of theatrical drugs decreased slightly
.
The patent expired drug Oevixibat in 2021 in this therapeutic area, with the trade name Bylvay, the domestic sample hospital data shows that the sales amount of drugs in the biliary drug treatment subcategory to which Oevixibat belongs is also showing an increasing trend year by year.
The compound growth rate from 2012 to 2021 will reach 10.
7%, and the market will start to pick up in 2021, and related companies can focus on it
.

Figure 1: 2012-2021 Sample Hospital Digestive System Drug Market Performance
Source: Drug Comprehensive Database (PDB), China Pharmaceutical Industry Information Center

2.
Potential therapeutic area 2: Nervous system drugs

Judging from the sales data of the national sample hospital drug market, the sales amount of neurological drug sample hospitals in 2021 will be 17.
52 billion yuan, and the compound growth rate from 2012 to 2021 is only 1.
8%.
And 2021 will be greatly affected by the new crown epidemic
.
In 2022, the patent expired drugs in related fields mainly include cannabidiol, lacosamide, etc.
The drug sales amount of the anti-epileptic drug treatment sub-categories in the domestic sample hospitals showed a relatively obvious growth trend, with a compound growth rate from 2012 to 2021 The rate reached 8.
9%
.

Figure 2: 2012-2021 Market Performance of Neurological Drugs in Sample Hospitals

Source: Drug Comprehensive Database (PDB), China Pharmaceutical Industry Information Center

3.
Potential therapeutic area 3: Endocrine and metabolic regulation drugs

Judging from the sales data of the national sample hospital drug market, the sales amount of endocrine and metabolic regulation drugs in the sample hospital in 2021 will be 15.
3 billion yuan, which has basically recovered the market size before the new crown epidemic; the compound growth rate of the market from 2012 to 2021 will reach 6.
6%
.
In 2022, the patent expired drugs in related fields are mainly liraglutide, insulin degludec + liraglutide compound, etc.
The drug sales of the GLP-1 analog treatment sub-category in domestic sample hospitals have grown rapidly, 2012-2021 The compound annual growth rate is 35.
3%
.

Figure 3: Market performance of endocrine and metabolic regulation drugs in sample hospitals from 2012 to 2021

summary

The first generic drug has become an important direction for the transformation and upgrading of pharmaceutical companies
.
On the one hand, the first generic drug usually means a large number of unmet clinical needs, which can bring considerable market returns; Transformation and upgrading of quality generic drugs
.
The drug patent link system in July 2021 clearly provides a one-year market exclusivity period for the first drug that challenges patents and is approved for marketing.
It is foreseeable that more pharmaceutical companies will enter the field of first generic drugs in the future
.

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
.

The China Pharmaceutical Industry Information Center empowers the pharmaceutical industry through big data, produces and publishes an annual overview of patent expired drugs every year, and continues to help enterprises in research and development through advanced and detailed patent data, and now provides "Overview of Patent Expired Drugs in 2022 (Selected)" PDF files for readers
.
For more details, please contact the company's sales staff
.