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Sanctura XR

Endo International plc

Drug Names(s): extended release trospium chloride

Description: BioMedTracker has separate drug profiles for the regular release and extended release (XR) formulations of Sanctura. Please also see Sanctura.

SANCTURA XR is a once daily formulation of Sanctura.

Trospium belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.

Trospium possesses a quarternary ammonium structure and thus does not appear to have the potential to cross the blood-brain barrier. At therapeutic concentrations in vitro, trospium does not interact with drugs metabolized by the Cytochrome P-450 system, a metabolic pathway commonly associated with drug-drug interactions, and it is excreted largely unchanged in the urine.

Trospium has been extensively studied and is currently marketed as a prescription drug product in Europe, where it is one of the leading products for overactive bladder/urinary incontinence.

Deal Structure: Indevus and Madaus
Indevus Pharmaceuticals licensed exclusive U.S. rights to trospium from Madaus AG, a German pharmaceutical company, in late 1999.

In November 2006, Indevus Pharmaceuticals announced that it licensed the rights to sell SANCTURA XR in certain territories outside the U.S., to Madaus GmbH. Under the terms of the agreement, Madaus has the right to sell SANCTURA XR outside the U.S. except in Canada, Japan, Koreaand China, where Indevus and Madaus will share equally in the economics. Madaus will pay Indevus a royalty on net sales and will purchase SANCTURAXR from Indevus at cost plus a manufacturing margin based on units sold in the Madaus territories. In addition, Madaus will be responsible for all payments to Supernus Pharmaceuticals, Inc., Indevus' drug delivery partner, in the Madaus territories.

Separately, the Company announced that Madaus has agreed to waive its rights under the original licensing agreement with Indevus to manufactureSANCTURA XR in...See full deal structure in Biomedtracker

Partners: Shire Pharmaceuticals Group PLC Teva Pharmaceutical Industries Ltd. Allergan plc Mylan Inc.

Sanctura XR News

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