Novartis antiepileptic drugs under supply pressure? MNC brand drug "Red Sea" is facing a breakthrough!

Developed by Novartis, oxcarbazepine was approved by the US FDA in 2000 and entered the Chinese market in 2004 under the trade name "Qulai"
.
Oxcarbazepine can block voltage-dependent sodium and potassium channels in patients with epilepsy, inhibit repeated nerve firing phenomena and synaptic excitation transmission in their bodies, and reduce the number
of seizures.
At present, oxcarbazepine is mainly used for monotherapy or additive therapy for simple and complex partial seizures, generalized tonic-clonic seizures, etc.
in adults and children with epilepsy, as well as adjuvant therapy
for refractory epilepsy.

Epilepsy is a common neurological disease, commonly known as "sheep epilepsy", which is a chronic disease
in which neurons in the brain suddenly fire abnormally, resulting in transient brain dysfunction.

According to the World Health Organization, there are about 50 million people with epilepsy worldwide, 40 million of whom are in developing countries
.
According to statistics, there are about 10 million epilepsy patients in China, and about 600,000 new patients
are added every year.
In China, epilepsy has become the second most common disease
in neurology after headache.

According to data from Intranet, the market size of terminal anti-epileptic drugs in China's public medical institutions will exceed 5.
6 billion yuan in 2021, a year-on-year increase of 11.
76%.

Sales of terminal anti-epileptic drugs in public medical institutions in China (10,000 yuan)

At present, the top 5 anti-epileptic drugs sold in domestic hospitals are sodium valproate, levetiracetam, oxcarbazepine, lamotrigine, and lacosamide, accounting for 84.
36% of
the drug market.

(Source: Intranet)

The demand for anti-epileptic drugs in China is not small, and the sales of oxcarbazepine rank third
in the terminal of public medical institutions in China.
However, from the financial report released by Novartis for the first half of this year, oxcarbazepine is no longer among
the top 20 products in its sales.

According to the data of sample hospitals in 22 cities in China, in 2005~2014, oxcarbazepine has maintained a rapid growth rate
.
Since 2012, the product has ranked 3rd in the field of anti-epileptic drugs, with a compound growth rate of 53.
2%.

In 2005, the amount of oxcarbazepine in sample hospitals nationwide was 2.
49 million yuan; In 2014, the amount of drugs used rose to 120 million yuan, and the overall market increased by 46.
5 times in 9 years
.

According to data from Intranet, since 2016, the sales growth rate of oxcarbazepine in public hospitals in key provinces and cities has slowed down, and since 2020, it has fallen into the quagmire of negative growth, and sales have gradually shrunk
.

(Source: Intranet)

In 2022Q1, the sales of public hospitals in key cities were 44.
51 million yuan, and tablets were the main dosage form (accounting for 87.
76%), with Novartis (91.
84%), Beijing Sihuan (4.
65%), and Wuhan Renfu (3.
5%) occupying nearly the entire market
.

While the market is shrinking, generic drugs are also on the market to share profits
.

At present, oxcarbazepine has generic drugs on the market
in China.
According to the official website of the State Food and Drug Administration, Beijing Sihuan Pharmaceutical Co.
, Ltd.
and Wuhan Renfu Pharmaceutical Co.
, Ltd.
have been approved for oxcarbazepine tablets, and three more are in the process of declaring
.

Although there are currently less than 3 generic drug companies that have been evaluated, oxcarbazepine has not been included in the national centralized procurement
.
However, oxcarbazepine tablets have appeared in the collection list of
some regions.

On January 19 this year, the Guangdong Drug Exchange Center issued the "Guangdong Alliance Diclofenac and Other Drugs Centralized Procurement Documents", oxcarbazepine tablets are prominently listed
.
Among the reports, Novartis' 0.
15g specification products reported more than Sihuan Pharmaceutical and Renfu Pharmaceutical's products, which also showed the market influence of the original product, however, in the end, Humanwell Pharmaceutical's 0.
3g specification oxcarbazepine tablets were selected at a price of 1.
0576/piece, while Novartis' 0.
15g specification oxcarbazepine tablets were proposed at a price of 1.
48/piece
.

As a competitive variety in anti-epileptic treatment, levetiracetam has further reduced the purchase price with the increase in the number of generic drug evaluation companies, which has also put pressure on oxcarbazepine; In addition, a large number of local companies such as Yangtze River, Qilu, Hengrui, Jiangsu Enhua and other local companies have accelerated the deployment of anti-epileptic treatment drugs, and the "red sea" of market competition should not be
underestimated.

The life cycle of brand products has a natural process, the patent cliff means that the "red sea" is coming, and under the impact of drug procurement, the original market share of multinational pharmaceutical companies' brand products is accelerated and squeezed, and the process of substitution of domestic generic drugs is accelerated.

Transformation and innovation to break out of the "Red Sea"