Qilu Pharma Enters the Over RMB 800 Million Triptorelin Market with New ANDA Filing
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On November 18, according to the CDE official website,Qilu PharmaceuticalInCategory 4Generic Drug ApplicationInjectable Triptorelin AcetateThe listing application has been accepted. According to the MaxEntropy Pharma database, this is another major domestic player entering the market after Livzon and Changchun Jin Sai Pharmaceutical, with production in China.TriptorelinIncreased market competition.
Screenshot source: CDE official website
Triptorelin（Triptorelin）It is a natural gonadotropin-releasing hormone analog.Triptorelin Acetate InjectionByDebiopharmThe earliest development was approved in China in 1995; its microsphere formulation was introduced to China by France's Ipsen in 2000, and later monopolized by Ipsen and Germany's Ferring for a long time. According to the MaxEntropy Pharma database, in 2024Triptorelin Acetate InjectionExceeding 800 million yuan in sales across all terminal hospitals in China, of whichIpsenHolds a 100% market share in all-terminal hospitals across China.
Screenshot source: Mosentropy Medicine All-Terminal Hospital Sales Database
May 2023,Livzon GroupSelf-developedTriptorelin Microspheres(Vibane) has been approved for marketing, becoming the first in China. In the same year, it was included in the National Medical Insurance Catalog and opened up the domestic market.Triptorelin Microsphere FormulationThe market has broken the situation of foreign capital monopoly.
Screenshot source: Mosentropy Medicine China Drug Approval Database
As of now,Triptorelin Acetate InjectionIn China, several companies such as Lai Mei Pharmaceutical, Changchun Jin Sai Pharmaceutical, and Shandong New Era Pharmaceutical have been approved for listing, among which six pharmaceutical companies have passed the consistency evaluation. In terms of generic drug layout, in January 2025, Hainan Zhonghe Pharmaceutical submitted a Class 4 generic application. With the participation of Qilu Pharmaceutical, domestically produced...TriptorelinMarket competition will further intensify.
Screenshot source: Mosentropy Medicine China Drug Evaluation Database
Since the beginning of this year, Qilu Pharmaceutical(Including Subsidiaries)More than 20 products have been approved and passed the evaluation, among whichIxazomib Citrate Capsules、Ibrutinib Tablets、Etoposide Injection、Amisulpride Injection、Olanzapine for InjectionFive products are the first to pass the evaluation.
Screenshot source: Mosentropy Medicine Approved Drug Summary Database
This time,Qilu PharmaceuticalTheTriptorelin Acetate InjectionEntering the market marks a further upgrade in the competitive landscape of domestically-produced triptorelin in China, with the competitive situation becoming increasingly intense. Local enterprises are making concerted efforts and actively striving forward, not only hoping to break through the market monopoly barriers set by foreign companies but also bringing more high-quality, affordable medication options to patients.
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