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Teva Settles With Lupin Over Austedo Patent

Teva Settles With Lupin Over Austedo Patent

Teva Pharmaceuticals and Lupin have settled their patent dispute over Lupin’s generic version of Teva’s Huntington’s disease drug, Austedo (deutetrabenazine).

Under the terms of the settlement, Lupin will be permitted to sell its generic deutetrabenazine beginning in April 2033.

Teva, which is still in litigation with Aurobindo over its generic version of the drug, projects that Austedo will generate approximately $1 billion in sales this year.

Deutetrabenazine

Deutetrabenazine (trade name Austedo) is a vesicular monoamine transporter 2 inhibitor which is used for the treatment of chorea associated with Huntington's disease and tardive dyskinesia.

Chemically, deutetrabenazine is an isotopic isomer of tetrabenazine in which six hydrogen atoms have been replaced by deuterium atoms. The incorporation of deuterium slows the rate of drug metabolism, allowing less frequent dosing.

Teva Pharmaceuticals received approval from the Food and Drug Administration to market deutetrabenazine in early 2017, along with five years of orphan drug exclusivity for the treatment of chorea associated with Huntington's disease. It was the first deuterated drug to receive FDA approval.

May 4, 2022

https://www.fdanews.com/


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