
UB587
ProductOlanzapine Orally Disintegrating Tablets
Strength5mg; 10mg; 15mg; 20mg;
IndicationsSchizophrenia; Mania; Bipolar disorder
TherapeuticsPsychiatry
GMPUS - FDA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- This Olanzapine Orally Disintegrating Tablet is registered in the US FDA and holds US FDA GMP certification, ensuring high quality assurance and compliance for global market access.
- The ODT dosage form improves patient adherence, especially for psychiatric patients with dysphagia or who refuse medication, indicating significant market demand potential globally due to high prevalence of mental illnesses.
- The original drug's patent has long expired, leading to a mature generic market, but ODTs still occupy a specific niche as a differentiated dosage form.
- Olanzapine is listed in the WHO Essential Medicines List and widely recommended as a first or second-line treatment for schizophrenia and bipolar disorder, signifying high clinical value and broad global acceptance.
- Compared to the originator drug, it offers a significant cost advantage, enabling partner pharmaceutical companies to achieve larger market shares in low- and middle-income countries or under healthcare cost containment policies.
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