Can China's First Generic Methylphenidate ER Alleviate the ADHD Medication Shortage?

In the past year, methylphenidate hydrochloride extended-release tablets (brand name of the original research drug: Concerta) have often been in a state of shortage.At the same time, several hospital pharmacies have clearly stated that various specifications of Concerta are out of stock. As a medication for treating Attention Deficit Hyperactivity Disorder (ADHD), many parents of children with ADHD are deeply anxious about the shortage of this drug. In response, Xian Janssen, the manufacturer of Concerta, told reporters from the Financial Associated Press: To expedite supply, it is expected that before the second quarter of this year, the packaging process for Concerta will be transferred from overseas to the Xi'an factory.

On the other hand, the first domestic generic version of Methylphenidate Hydrochloride Extended-Release Tablets has been successfully developed by Hefei Lifeon Pharmaceutical Co., Ltd. The company expects no significant issues with production capacity and believes it can meet market demand.Doctors pointed out to the Caixin reporter that, in the situation where original research drugs are often out of stock, patients' families will gradually accept domestically produced generic drugs.

Multiple Hospitals Focus on Stockouts

Since last year, the medication for children with ADHD —— Concerta has been in a continuous state of short supply. Many parents have reported on social media platforms that there have been instances of Concerta being out of stock. Some parents frankly stated, "Either scrambling for the drug or asking where it can be found."

It is reported that Focalin was developed by Johnson & Johnson in the United States, imported and repackaged by Xian Janssen, and belongs to the Class I psychotropic drug under national control for the treatment of ADHD. The marketing authorization holder is Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson.

Xian Janssen Responds to Cailian Press: Johnson & Johnson Always Prioritizes the Needs of Patients and Healthcare Professionals. The current supply of Concerta is affected by production limitations and increasing global demand. The company is taking multiple measures to enhance global production capacity in order to stabilize supply to various markets. To better meet the needs of the Chinese market, it is expected that before the second quarter of 2025, the company will transfer the packaging process of Concerta from overseas to the Xian factory, thereby accelerating the supply to the Chinese market. In regions with temporary supply shortages, patients using Concerta are advised to consult with their attending physicians to formulate transitional treatment plans.

Regarding the potential impact of the additional tariffs imposed by China and the U.S., a reporter from Cailian News contacted Xian Janssen's customer service hotline, posing as a family member of a young patient. The staff responded that they had not received any related information so far and were also uncertain whether there would be any price adjustments.

According to the annual report, in 2024, the sales revenue of Concerta under Johnson & Johnson was $641 million, a year-on-year decrease of 18.1%. However, data from Mosis shows that, based on sales data from hospitals across China, the sales revenues for the 18mg, 27mg, and 36mg specifications of Concerta were 386 million yuan, 9.18 million yuan, and 59.334 million yuan respectively in 2024.

During the visit, reporters from Cailian She discovered that the shortage of Concerta indeed exists. Staff at the pharmacy of Hubei Maternal and Child Health Care Hospital stated that various specifications of Concerta are currently out of stock and have been for some time; it is unclear when new supplies will arrive. Additionally, hospitals such as Shenzhen Children's Hospital already allow patients to check the availability of Concerta via their WeChat official account. It was also learned that both the 18mg and 36mg dosages of imported methylphenidate hydrochloride extended-release tablets (Concerta) are currently out of stock at Beijing Children’s Hospital’s Psychiatric Department.

Will Domestic Substitution Alleviate Supply Pressure?

It is worth noting that,In the event of a shortage of the original drug, a domestically produced extended-release methylphenidate hydrochloride tablet has been recently approved for marketing in China and has garnered significant attention in the secondary market.

On the evening of April 14, Hefei Lifeon Pharmaceutical Co., Ltd. announced that it had received the "Drug Registration Certificate" for Methylphenidate Hydrochloride Extended-Release Tablets issued by the National Medical Products Administration. The company stated that this drug belongs to the first class of psychotropic substances and is mainly used clinically to treat attention deficit hyperactivity disorder. This product adopts advanced three-layer osmotic pump controlled-release technology, achieving rapid onset through precise controlled release and effectively maintaining stable efficacy throughout the day. As of the date of the announcement, apart from our company's product, there is only one imported drug approval number for this product in China, and no other companies have entered the clinical research or registration application stage.

From April 15 to April 21, Hefei Lifeon Pharmaceutical Co., Ltd. received five consecutive limit-up trading days. On April 17 and 21, the company issued two announcements regarding abnormal stock trading fluctuations, stating that due to potential impacts on drug production and sales from policies and market factors, the specific influence of the market launch of Methylphenidate Hydrochloride Extended-Release Tablets on the company’s performance remains uncertain. Investors were advised to invest rationally and be mindful of risks.

Hefei Lifeon Pharmaceutical Co., Ltd. told reporters from the Financial News Agency that the bioequivalence of the extended-release methylphenidate hydrochloride tablets was established by referencing Concerta and passed the consistency evaluation, meaning that clinically, the efficacy is the same. Regarding commercialization, the staff member stated that the pricing has not yet been finalized internally. Due to some production processes still pending in the pharmaceutical regulatory system, the product can only be launched after these processes are completed. As a red prescription drug, its distribution may be relatively more fixed, requiring designated delivery points, and management during use will also be stricter. The staff member further added, "We believe there should not be significant issues with production capacity. Our company is already quite experienced with this type of formulation, so we are confident. As long as there is market demand, our product supply should not encounter major problems." When asked about the impact of current additional tariffs on the company, they responded that the impact on the cost side might be minimal, but it is uncertain whether it will affect imported drugs and thus influence their sales in China.

Data from MoEntropy Pharma shows that the specification of Hefei Lifeon Pharmaceutical's Methylphenidate Hydrochloride Extended-Release Tablets submitted for application is 18mg. The clinical trial was approved on May 28, 2022, and the marketing application was submitted on November 23, 2023.

Doctor from a Women and Children's Hospital in Sichuan told the Caixin reporter that Attention Deficit Hyperactivity Disorder (ADHD) requires strict evaluation. Symptoms generally appear in younger children, and early intervention and treatment are necessary. Severe cases of ADHD during high school years may affect a student’s ability to continue schooling. While there hasn’t been specific statistical data collected, there is an increasing trend in the number of children diagnosed with ADHD. In situations where original researched drugs are often out of stock, families of patients gradually accept domestically produced generic drugs. At the same time, the doctor emphasized that Concerta must be used under strict supervision to ensure its efficacy while preventing the risk of abuse, safeguarding medication safety.

Industry expert Li Changcheng analyzed and believed for the Caixin reporter,The shortage of original drugs may lead to ADHD patients being unable to receive necessary treatment; the launch of the first generic drug could potentially alleviate this crisis and prevent delays in treatment due to drug shortages.In addition, the state currently strongly encourages the first generic drugs. Through certain market public relations and academic activities to educate consumers and cultivate doctors' prescribing habits, China-produced extended-release methylphenidate hydrochloride tablets are expected to achieve rapid hospital sales. However, during the commercialization process, some patients and doctors may have concerns about generic drugs, so manufacturers need to continuously ensure production capacity and subsequent quality. Notably, Li Changcheng believes that under the situation of tariff increases between China and the US, it is a great opportunity for domestic generic drugs to seize the market.

This article comes from the WeChat Official Account"ChiNext Observation", Author: He Fan, 36Kr authorized publication.