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Recently, Novartis issued a statement saying that its anti-epileptic drug oxcarbazepine (Qulai) has limited product supply due to the shortage of key raw materials in production
.
Later, Novartis has temporarily solved the risk
of supply shortage of oxcarbazepine through resource coordination.
So at present, what is the domestic anti-epileptic drug market structure? What kind of competitive pressure will oxcarbazepine encounter in the future?
Analysis of the market pattern of TOP5 anti-epileptic drugs
Analysis of the market pattern of TOP5 anti-epileptic drugsEpilepsy is a chronic brain disease caused by a variety of etiologies, characterized by recurrent, seizures and transient central nervous system dysfunction caused by excessive firing of brain neurons, loss of consciousness during seizures, if status epilepticus is not terminated in time, can lead to irreversible brain damage due to high fever, circulatory failure or neuronal excitotoxic damage, the disability rate and mortality rate are high
.
According to Frost & Sullivan's analysis, in 2016, there were 544,000 patients with status epilepticus in China, which increased to 753,000 in 2020, and it is expected that the number
of epilepsy patients in China will exceed 1 million in 2024.
With the gradual increase of the number of patients with epilepsy, it is expected that China's anti-epileptic drug market will reach 4.
8 billion yuan
in 2025.
At present, drugs are the main means of anti-epileptic treatment, and their purpose is to control the symptoms of epilepsy and reduce the number of
incidences.
At present, the top five domestic anti-epileptic drugs are: valproate, levetiracetam, oxcarbazepine, pregabalin, lamotrigine, accounting for 84.
82%
of the market share of epilepsy drugs.
82%
of the market share of epilepsy drugs.
Sodium valproate
Sodium valproateDeveloped by Abbott, sodium valproate is a fatty acid derivative that acts primarily on GABAA receptors (γ-aminobutyric acid type A receptors) and NMDA receptors (N-methyl-D-aspartate receptors).
In 2001, sodium valproate was approved by Sanofi to enter the Chinese market
.
As a broad-spectrum epilepsy drug, valproate is suitable for almost all types of epilepsy and seizures, and is the first-line drug for the clinical treatment of epilepsy, but its efficacy is slightly lower than that of other new anti-epileptic drugs
.
Sodium valproate has been used in clinical practice for more than 50 years
worldwide.
In 2020, the total sales of sodium valproate in China exceeded 1.
8 billion yuan, and sales increased steadily at a growth rate of 76% in the first half of 2021
.
After the patent expired, the generic drugs of Shenyang Xinma Pharmaceutical and Sichuan Creide were successively approved for marketing, seizing the market share
of the original research.
Levetiracetam
LevetiracetamLevetiracetam was developed by UCB Belgium as a second-generation acetylcholine agonist developed by UCB for the treatment of localized and secondary generalized epilepsy
.
In 1999, levetiracetam was approved by the FDA in tablet form as an antiepileptic drug
with the effect of preventing the onset of epilepsy.
In 2017, global sales of levetiracetam reached $778 million
.
Levetiracetam entered the Chinese market in 2006 and is the only anti-epileptic drug that has been evaluated before the first batch of national procurement declarations, with the advantages of good tolerance and reliable efficacy, but the patient's recovery is not good in the later stage, and the recurrence rate of epilepsy is high
.
After the expiration of the levetiracetam patent, the products of Zhejiang Jingxin Pharmaceutical, Shenzhen Salubris Pharmaceutical, Chongqing Shenghuaxi Pharmaceutical, Zhuhai Federal Pharmaceutical and other enterprises have been approved
one after another.
Jingxin Pharmaceutical's levetiracetam tablets (0.
25g) is the first product
in China to pass the consistency evaluation of this variety.
Oxcarbazepine
OxcarbazepineOxcarbazepine, trade name Qulai, developed by Novartis Pharmaceuticals, is a new generation of anti-epileptic drugs, which can block voltage-dependent sodium and potassium channels in patients with epilepsy, inhibit repeated nerve firing phenomena and synaptic excitation transmission in the body, reduce the number of seizures, and is the first-line treatment drug choice
for newly diagnosed epilepsy in adults.
Oxcarbazepine was approved by the FDA in 2000 for the treatment of epilepsy in adults and children, and was approved for marketing
in China in 2004.
So far, it has been widely used
in more than 50 countries or regions around the world.
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.
In 2005~2014, oxcarbazepine has maintained a rapid growth rate
.
In 2005, the amount of oxcarbazepine in the hospital was 2.
49 million yuan; In 2014, the amount of drugs used rose to 120 million yuan, an increase of 46.
5 times
in 9 years.
After the expiration of the oxcarbazepine patent, domestic generic drugs have also been listed one after another, and currently occupied nearly the entire market
by Novartis, Beijing Sihuan and Wuhan Renfu.
Pregabalin
PregabalinDeveloped and produced by Pfizer, pregabalin is a novel neurotransmitter γ-aminobutyric acid structural analogue that reduces the release
of neurotransmitters by blocking voltage-dependent calcium channels.
Clinically it is mainly used for neuralgia related to diabetic peripheral neuropathy, adjuvant treatment of partial seizures in adults, generalized anxiety disorder, neuropathic pain of myeloid injury, etc
.
Pregabalin is a world-selling blockbuster drug, and in 2020, the sales of pregabalin in China's urban physical pharmacy terminals exceeded 100 million yuan, a year-on-year increase of 35.
91%.
Pregabalin's patent exclusivity expired in June 2019, and a number of generic drug products have been listed
in China.
Pregabalin capsules were included in the fourth batch of centralized procurement, and 4 enterprises including Qilu Pharmaceutical, Chongqing Saiwei, China Resources Shuanghe and Kolkang Menova Pharmaceutical won the bid.
Lamotrigine
LamotrigineLamotrigine, developed by GlaxoSmithKline (GSK), is a triazabenzene compound
with antifolate activity.
Lamotrigine exerts antiepileptic effects
by blocking sodium channels and stabilizing cell membranes, thereby preventing the release of excitatory nerve mediators such as glutamic acid.
As a broad-spectrum antiepileptic drug, lamotrigine is mainly used clinically for monotherapy or adjuvant therapy for partial and generalized seizures, and can also be used as an emotional stabilizer
Type I bipolar disorder
.
Compared with classical antiepileptic drugs, lamotrigine is well tolerated, insignificant in enzyme induction and inhibition, and toxic during pregnancy
Advantages
such as less sex.
In addition, lamotrigine is extremely effective for partial seizures and secondary generalized seizures, but it is less
effective for primary generalized seizures.
Lamotrigine was approved by the FDA in 1994 and approved for domestic marketing
in 1999.
In 2018, the global market sales of lamotrigine formulations, including all formulation dosage forms, were approximately $1.
46 billion
.
With the expiration of patents, domestic generic drugs have gradually been approved for marketing, such as domestic Huahai Pharmaceutical
.
From the current situation, the domestic anti-epileptic drug market is still dominated by original imported products, but as generic drugs gradually grab the beach, the market share of original research brands is compressing
.
At present, China has about one-fifth of the world's epilepsy patients, but the treatment gap for domestic epilepsy patients is more than
63%.
This means that the domestic anti-epileptic drug market will be further enlarged in the future, and it is also a new opportunity
for the development of domestic generic drug companies.
Key References:
Main References: Main References:
1.
"Novartis is going out of stock", Medicine Sra Plus, 2022-10-11
"Novartis is going out of stock", Medicine Sra Plus, 2022-10-11
2.
The latest clinical diagnosis and treatment guidelines for epilepsy, Peking Union Medical College 2017,8(2-3):122
The latest clinical diagnosis and treatment guidelines for epilepsy, Peking Union Medical College 2017,8(2-3):122
3.
Current status of epilepsy treatment and drug discovery, Acta Pharmaceutica Sinica, 10.
16438/J.
0513-4870.
2020-1578
Current status of epilepsy treatment and drug discovery, Acta Pharmaceutica Sinica, 10.
16438/J.
0513-4870.
2020-1578
4、Theodore WH，Spencer SS，Wiebe S，et a1． Epilepsy in north america：a report prepared under the auspices of the global campign against epilepsy， the international league against epilepsy and the world health organization[J]． Epilepsia，2006，47(10)：1700_1722
4、Theodore WH，Spencer SS，Wiebe S，et a1． Epilepsy in north america：a report prepared under the auspices of the global campign against epilepsy， the international league against epilepsy and the world health organization[J]． Epilepsia，2006，47(10)：1700_1722
