On April 20, the drug notification showed that both formulations of Ondansetron, orally disintegrating tablets and oral soluble film, failed on the same day.Ondansetron is already one of the most successful drugs in this category of mucosal drug delivery, yet it still fails frequently, indicating that the difficulty of orally disintegrating tablets and oral dissolving films is indeed not low.Specifically, looking at the failure of these two companies, the first is the failure of Beijing Xinghao Pharmaceutical's Ondansetron Orally Disintegrating Tablets.This company is indeed a bit "unfortunate," especially in the area of orally disintegrating tablets (ODTs). Previously, Beijing Xinghao had twice attempted to challenge oseltamivir phosphate ODTs, both of which were rejected. Undeterred, they proceeded with a third submission, this time directly filing an IND, and have now received clinical approval. See detailed analysis:Total Loss Products, Third Submission!Now it has been changed to a different variety, Ondansetron Orally Disintegrating Tablets,Beijing XinghaoStill no success.Actually, the component ondansetron is quite unusual. Theoretically, the production process of orally dissolving films is more complex than that of orally disintegrating tablets, and the equipment requirements are also higher. Typically, orally disintegrating tablets would be rolled out first. However, in the case of ondansetron, there are more companies that have received approval for orally dissolving films, while not a single one has passed the evaluation for orally disintegrating tablets to date.Another failed product is the Ondansetron Oral Soluble Film from Zhejiang Hengyan Pharmaceutical.As mentioned above,Ondansetron oral soluble film is much smoother compared to the orally disintegrating tablet.This orally disintegrating film is arguably the most advanced variety in China's orally disintegrating film sector. Currently, there are only 9 types of orally disintegrating films available in China. Ondansetron Orally Disintegrating Film has been approved for marketing by the highest number of companies, with a total of 5 enterprises holding its license, while most of the others are either exclusive to one company or held by two.Zhejiang Hengyan Pharmaceutical, which was rejected this time, marks the first failure record for the Ondansetron Oral Soluble Film.Zhejiang HengyanCompleted the BE trial at the beginning of 2025, submitted the marketing application in May, and after more than 300 days of review, no opportunity for supplementary submission was given.
Source: Mesentech Pharmaceuticals
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Ondansetron isAnti-emetic drugs used clinically after first-line chemotherapy,Initially discovered by GSK, it was first launched in the UK in 1990 and is available in various formulations, including tablets, injections, oral solutions, and orally disintegrating tablets.However, in China, it was not the original research that came to market first. Instead, in 1996, Fuan Pharmaceutical launched tablets and injections ahead of GSK. It was not until 2001 that GSK introduced tablets and injections in China. These two forms are the main dosage forms of the ondansetron component, dominating the market. Currently, both tablets and injections have been included in centralized procurement. The original research has almost no market presence in China, where domestically produced products dominate.But at the same time, since ondansetron is an antiemetic component, there are drawbacks to taking the aforementioned dosage forms, thus globallyThe development of new formulations of ondansetron has always been a hot topic, such asOrally Disintegrating Tablets, Oral Dissolving Films, and so onUnique dosage forms such as capsule agents and freeze-dried powders developed in China.GSK, the original research company, developed ondansetron orally disintegrating tablets but did not develop oral soluble films. GSK's ondansetron orally disintegrating tablets were launched in the United States as early as 1999, but have not been marketed in China ever since.In 2008 and 2009, China National Pharmaceutical Group Corporation and Beijing Shuangji successively launched their domestically produced generic versions in China. At that time, they followed the old registration classification. These two companies did not subsequently conduct a consistency evaluation becauseOndansetron Orally Disintegrating TabletsNot covered by medical insurance for many years, so the sales performance has not been good.The reference preparation for Ondansetron Orally Disintegrating Tablets was confirmed in 2022 as GSK's product. Strangely, no company has attempted to replicate this variety since the reference preparation was established.The failed Beijing Xinghao is the only one that has been laid out, but it failed.As for the orally dissolving film formulation, it was not actually developed by GSK but originated from the United States.Led by MonoSol Rx,Swiss APR + German Labtec jointly developed by three parties, the ownership of the enterprise has changed several times, and it is inconsistent in the United States and the European Union.Ondansetron oral soluble film, originally developed but not marketed in China, was first successfully replicated and launched by Jiangsu Hengrui in 2022 after a review process lasting over four years. However, the product has seen lackluster sales performance. To date, Hengrui has only introduced this single oral soluble film product and has since made no further moves in this field.After Hengrui, Ondansetron Oral Soluble Film has been approved by four more companies: Jiangsu Hechen, Sichuan Kelun, Hangzhou Muyuan, and Shanghai Xinfeng. This variety was included in the National Medical Insurance Negotiation Catalog in 2022 and officially transitioned to the regular catalog in 2025.The current market for Ondansetron Oral Soluble Film is over 200 million yuan. Although it is not a large-scale product, its inclusion in the medical insurance indicates the possibility of future growth. Moreover, the technical difficulty is relatively controllable. Companies that want to enter the oral soluble film market usually choose it as their first option.Ondansetron Oral Soluble FilmThe generic drug marketing applications of two companies, Bozhiyan New and Shanghai Pharmaceuticals, are currently under review.
Source: Mosun Medicine
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