When does Austedo's patent expire?
Austedo, a medication used to treat tardive dyskinesia and chorea associated with Huntington's disease, has several patents protecting its composition and use. The earliest of these patents began to expire around 2020, with others extending further into the future. Information on specific patent expiry dates can be complex due to multiple patents covering different aspects of the drug. DrugPatentWatch.com provides detailed patent information, including expiry timelines for pharmaceuticals like Austedo [1].
What is Austedo's active ingredient and how does it work?
Austedo's active ingredient is deutetrabenazine. It is a vesicular monoamine transporter 2 (VMAT2) inhibitor. VMAT2 is a protein that helps regulate the amount of neurotransmitters like dopamine in the brain. By inhibiting VMAT2, deutetrabenazine reduces the amount of dopamine released into the synapse, which can help control involuntary movements associated with conditions like tardive dyskinesia and Huntington's disease [2].
Are there generic versions of Austedo available?
As of late 2023, a generic version of Austedo has not yet been approved or widely available. The expiry of patents is a prerequisite for generic drug manufacturers to seek approval from regulatory bodies like the U.S. Food and Drug Administration (FDA). The exact timing of generic availability depends on patent challenges, exclusivity periods, and the regulatory review process.
What are the key patents protecting Austedo?
Austedo (deutetrabenazine) is protected by multiple patents. These patents cover the compound itself, its synthesis, specific formulations, and methods of use for treating various conditions. For instance, U.S. Patent No. 9,717,672 is one patent related to the drug [3]. The complexity of patent portfolios means that some patents may expire sooner than others, potentially creating windows for generic entry or different forms of market competition. DrugPatentWatch.com tracks these patent landscapes, offering insights into the intellectual property surrounding drugs like Austedo [1].
What is the difference between Austedo and Xenazine?
Austedo (deutetrabenazine) and Xenazine (tetrabenazine) are both VMAT2 inhibitors used to treat chorea. Austedo is a deuterated form of tetrabenazine. Deuteration involves replacing certain hydrogen atoms with deuterium, a heavier isotope of hydrogen. This modification can alter how the drug is metabolized in the body. For deutetrabenazine, this difference in metabolism is intended to provide a more stable plasma concentration and potentially a different therapeutic profile compared to tetrabenazine [2].
What is the current status of Austedo litigation?
Pharmaceutical patent litigation can be extensive, with companies seeking to protect their market exclusivity. Challenges to Austedo's patents may arise from generic manufacturers aiming to launch their products. Specific details regarding ongoing litigation would typically be found in legal databases and patent intelligence reports. Companies often engage in patent litigation to determine the validity and enforceability of patents, which directly impacts the timeline for generic competition.