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The "patent cliff" refers to the phenomenon
that after the expiration of the patent protection period of a blockbuster drug, generic drugs enter and occupy the market at a lower price, resulting in a sharp decline in the sales of patented drugs.
For a long time, generic drugs in China's market can hardly compete with imported expired patented drugs, and the price reduction of imported drugs has not appeared
.
The data shows that patented drugs in developed countries account for 80% of the amount with 20% of the quantity, and generic drugs account for 80% of the amount in exchange for 20% of the amount; However, China's generic drugs account for as much as 60%-65%
of the amount before procurement.
It can be seen that before the collection of mining, China did not form an effective "patent cliff"
.
.
Since 2018, the state has organized seven batches of drug procurement, covering more than 290 drugs, and the procurement of provincial and inter-provincial alliances has also continued to be promoted, the price of purchased varieties has been greatly reduced, domestic substitution has accelerated, and the "patent cliff" has also emerged
.
This article will select a few typical cases to introduce
.
Valsartan amlodipine
Valsartan amlodipine Valsartan amlodipine tablets (original trade name: Bebot), developed by Novartis, are a single combination tablet composed of angiotensin receptor antagonist (ARB) valsartan and calcium-channel antagonist amlodipine, suitable for patients with valsartan monotherapy or amlodipine monotherapy for patients
who have not adequately controlled blood pressure.
BEBOTECH entered the Chinese market at the end of 2009 and has not had any new competitors until 2019, and Novartis has maintained a market monopoly
for up to 10 years.
for up to 10 years.
Until February 2020, Baiao Pharmaceutical's valsartan amlodipine tablets were approved as a new class 4, which was regarded as passing the consistency evaluation of generic drugs, and Baiao Pharmaceutical became the first generic manufacturer
of this classic compound antihypertensive drug in China.
As the only single-tablet compound antihypertensive drug that has entered the national essential drug list, Bebote has a broad mass drug base, according to PDB national sample hospital market data, Bebote's sales growth rate has been maintained at about 10% all year round, reaching peak sales in 2020, about 600 million yuan (2.
4 billion yuan after amplification).
With the gradual increase in the number of approved generic drugs in China, valsartan amlodipine tablets are included in the fourth batch of national procurement, the patent cliff of Bebote has accelerated, and Novartis' market monopoly has also been broken
.
According to PDB's national sample hospital market data, Novartis' market share shrank to 78% in 2021, and its market share in the first half of 2022 was less than 50%, or 47%, a sharp drop of 53 percentage points
from 2020.
from 2020.
Figure 1: Valsartan amlodipine sales ratio (%) PDB drug comprehensive database by each manufacturer
In contrast, the market shares of the selected enterprises Garden Pharmaceutical and Hengrui Pharmaceutical reached 30% and 21% respectively in the first half of 2022, and it is expected that the share of the selected enterprises will further increase as the centralized procurement continues to be
implemented.
Budesonide
Budesonide Budesonide suspension is an inhaled glucocorticoid administered through a nebulizer, originally developed by AstraZeneca's "pumiklingshu"
.
Inhalation therapy is the first choice for the prevention and treatment of asthma and other respiratory diseases, inhaled drugs can directly reach the respiratory tract and lungs, budesonide perennial stable inhalant product "brother", with fast onset, small dose, small toxic side effects and other advantages
.
According to PDB's national sample hospital market data, the sales growth rate of budesonide is basically more than 10%, reaching a peak of sales in 2019, which is 1.
5 billion yuan (nearly 7 billion yuan after amplification), which belongs to the market of large varieties
.
Although there have been many budesonide manufacturers over the years, including AstraZeneca, Changfeng Pharmaceutical, Lunan Beit and many other original and generic drug companies, AstraZeneca has maintained the absolute leading position of budesonide, with a market share of more than
90%.
90%.
Until the fifth batch of national procurement included budesonide, AstraZeneca was unfortunately out, and Chia Tai Tianqing, Health Yuan, Changfeng Pharmaceutical and Praitt were selected to jointly divide the original research market
.
The fifth batch of national procurement began to be implemented in October 2021, and according to PDB's national sample hospital market data, by the end of 2021, although the national procurement had only been implemented for two months, AstraZeneca's market share had shrunk to 73%.
As of the first half of 2022, Aslakorn's market share shrank further to 41%, a significant decrease of 47 percentage points
from 2020.
from 2020.
Figure 2: Proportion of sales of budesonide manufacturers over the years (%) PDB drug comprehensive database
Correspondingly, the market shares of the selected enterprises Chia Tai Tianqing, Healthyuan, Changfeng Pharmaceutical and Pratt reached 18%, 8%, 6% and 11% respectively, accounting for a total of 43%, which has caught up with the original research, and it is expected that as the centralized procurement continues to be implemented, the market share of the selected enterprises will further increase
.
Compared with valsartan amlodipine tablets, budesonide "patent cliff" phenomenon is more typical
.
As early as 2012, budesonide has a number of domestic generic drug companies to compete, but the original research company has maintained an absolute dominant position, the patent cliff has not arrived, and collective procurement has really changed this situation
.
.
Levetiracetam
Levetiracetam Levetiracetam is a new broad-spectrum anti-epileptic drug, which has become one of
the most widely used anti-epileptic drugs for focal and generalized epilepsy due to its good efficacy and tolerability.
As a commonly used anti-epileptic drug in clinical practice, levetiracetam has been included in centralized procurement twice, namely 4+7 centralized procurement into levetiracetam tablets, and the third batch of national procurement into levetiracetam oral solution and concentrated solution
for injection.
According to PDB's national sample hospital market data, levetiracetam tablets are the mainstream dosage form, and the proportion of sales before 2017 remained above 90%, which has declined in the past two years and is still about
80%.
Concentrated solutions for injection have benefited from centralized procurement, and their market share has increased significantly in recent years, and as of the first half of 2022, the sales of concentrated solutions for injection have accounted for 18%.
80%.
Figure 3: Proportion of sales of levetiracetam dosage forms over the years (%) PDB drug comprehensive database
The original research company of levetiracetam is the Belgian company UCB, which was approved to enter China at the end of 2006, and after the patent expired in 2009, some domestic companies began to imitate, but like budesonide, the original research status has not been shaken
.
As of 2018, the market share of Uniratio is still as high as 97%.
Figure 4: Percentage of sales of levetiracetam manufacturers over the years (%) PDB drug comprehensive database
With the implementation of 4+7 centralized procurement and the third batch of centralized procurement, the market share of Ushibi has declined rapidly, from 97% to 85%, 63%, 46%, and as of the first half of 2022, the market share of Ushibi has further decreased to 41%, a decrease of 56 percentage points
from 2018.
In contrast, the market share of Zhejiang Jingxin Pharmaceutical, the selected enterprise in the "4+7" centralized procurement, has increased significantly, accounting for more than 30%.
from 2018.
brief summary
brief summary In the past ten years, many original drug patents in China's drug market have expired, and domestic companies have begun to imitate them, but the patent cliff has not yet arrived, which not only increases the burden of patients' medication, but also affects the reasonable revenue growth of
generic drug enterprises.
Centralized procurement has effectively changed this state, bringing opportunities for domestic generic drug companies to reshuffle, and also bringing more choices
to patients to reduce the burden of medication.
In the long run, the "patent cliff" problem has been effectively solved, which is also conducive to purifying the business environment and driving the industry and market structure to continue to improve
.
