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Mylan launches generic Uroxatral

Mylan Inc has begun to distribute a generic version of Uroxatral, a treatment for benign prostatic hyperplasia made by sanofi-aventis, through its subsidiary Mylan Pharmaceuticals
Mylan Pharmaceuticals has begun to ship alfuzosin hydrochloride extended-release tablets 10mg, a generic version of sanofi-aventis' Uroxatral (marketed as Xatral outside of the US and as Prostetrol in Egypt), for the treatment of benign prostatic hyperplasia (BPH).

BPH is an enlarging of the prostate, which can impede the flow of the urine from the bladder to the urethra, resulting in urinary retention. Alfuzosin, an antagonist of the post-synaptic alpha-1 adrenoreceptor (found in the prostate, bladder neck, prostatic capsule and prostatic urethra), is a vasodilator, which relaxes the muscles of the prostate and bladder, relieving the symptoms of (but not curing) BPH.

Mylan's actions follow a decision of the United States District Court for the Northern District of West Virginia, which ruled last month that the abbreviated new drug application (ANDA) for the generic drug filed by Mylan with the US Food and Drug Administration (FDA) does not infringe sanofi-aventis patents. This overturns a previous decision handed down in May 2010 by the US District Court for the District of Delaware, which ruled that Mylan's ANDA did indeed violate sanofi's patents.

Mylan had received tentative FDA approval for generic uroxatral in October 2008, and full approval after the West Virginia District Court decision in July 2011. Generic alfuzosin has received an 'AB' rating from the FDA, designating it biologically equivalent to Uroxatral, which first received FDA approval in June 2003 and was marketed from November of that year. Xatral, which is also indicated as an adjunctive therapy for acute urinary retention, has been approved in Europe since April 2000 and in Canada since March 2005.

For the twelve months ending June 30 2011, Uroxatral had US sales of approximately $241m, which represented a substantial increase on the $168m annual sales of the drug for the 12 months ending June 30 2008. Mylan currently has a further 162 ANDAs awaiting FDA approval (43 of which represent potential first-to-file opportunities), worth an approximate $94.4bn in total annual sales.

Mylan does not have marketing exclusivity for generic alfuzosin: other companies currently producing generic versions of Uroxatral also include Apotex, Sun Pharma, Teva and Torrent.

15th August 2011


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