Ingrezza holds a significant market share in the treatment of tardive dyskinesia, a neurological disorder characterized by involuntary movements. Austedo is another medication approved for tardive dyskinesia. While specific, up-to-the-minute market share data directly comparing Ingrezza and Austedo is not publicly available in the provided information, Ingrezza has been noted for its strong commercial performance and market penetration since its launch.
How do Ingrezza and Austedo work?
Ingrezza (valbenazine) functions by selectively inhibiting the vesicular monoamine transporter 2 (VMAT2) in the brain. This action reduces the amount of dopamine released into the synapse, which is believed to be a key factor in the involuntary movements associated with tardive dyskinesia [1].
Austedo (deutetrabenazine) also targets the VMAT2 pathway. It is a deuterium-modified version of tetrabenazine, which also depletes monoamines like dopamine. The deuterium modification in Austedo aims to alter its metabolism, potentially leading to a more predictable pharmacokinetic profile and longer-lasting effects compared to tetrabenazine [2].
When can generic versions of Ingrezza and Austedo become available?
The patent landscape for both Ingrezza and Austedo is complex and influences when generic versions can enter the market.
For Ingrezza, the primary patent is expected to expire in 2034. However, there are also other patents related to its manufacturing and formulation that could extend market exclusivity. Challenges to these patents could potentially lead to earlier generic entry [3].
Austedo also has several patents covering its composition of matter, use, and manufacturing. The earliest expiry dates for some of these patents are in 2032 and 2033. Similar to Ingrezza, patent challenges and litigation could impact the timeline for generic Austedo availability [4].
What are the approved uses for Ingrezza and Austedo?
Both Ingrezza and Austedo are approved by the U.S. Food and Drug Administration (FDA) for the treatment of tardive dyskinesia. Ingrezza is indicated for adults experiencing these involuntary movements [1]. Austedo is approved for adults with tardive dyskinesia and chorea associated with Huntington's disease [2].
What are the key differences in how Ingrezza and Austedo are taken?
Ingrezza is typically taken once daily, simplifying the dosing regimen for patients [1].
Austedo is also taken orally, but its dosing schedule may vary. It is often initiated at a low dose and then titrated upwards based on patient response and tolerability. Patients may take Austedo once or twice daily depending on the prescribed regimen [2].
What are the potential side effects of Ingrezza and Austedo?
Common side effects reported for Ingrezza include somnolence (drowsiness) and oral dryness [1].
For Austedo, common side effects can include upper respiratory tract infections, insomnia, and drowsiness. Austedo carries a boxed warning for depression and suicidality in patients with Huntington's disease, a risk also associated with tetrabenazine products [2].
What clinical data supports Ingrezza and Austedo?
Ingrezza's efficacy in treating tardive dyskinesia has been demonstrated in multiple clinical trials, such as the VNĔRATION studies, showing statistically significant reductions in abnormal involuntary movement scale (AIMS) scores compared to placebo [1].
Austedo's effectiveness for tardive dyskinesia was established in clinical studies, including AIM-TD, where it showed significant improvement in AIMS scores. Its efficacy in Huntington's disease chorea was shown in the first 2 pivotal trials for that indication [2].
Who manufactures Ingrezza and Austedo?
Ingrezza is manufactured by Neurocrine Biosciences [1].
Austedo is manufactured by Teva Pharmaceuticals [2].
What other treatments are available for tardive dyskinesia?
Besides Ingrezza and Austedo, other VMAT2 inhibitors like Austedo's predecessor, tetrabenazine, are also used. In some cases, physicians may consider off-label use of other medications or non-pharmacological interventions, though VMAT2 inhibitors are the primary FDA-approved drug class for tardive dyskinesia.
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Sources:
[1] https://www.ingrezza.com/
[2] https://www.austedo.com/
[3] https://drugpatentwatch.com/brand/ingrezza
[4] https://drugpatentwatch.com/brand/austedo