Prostate drug tamsulosin (Flomax) generic to be launched in US by March 2010 : Daiichi-Ranbaxy

Daiichi Ranbaxy is planning to launch a generic version of tamsulosin to treat enlarged prostate in US by March 2010.

Tamsulosin is currently sold in the brand name Flomax and is originally developed and marketed by Astellas Pharma of Japan.

Flomax (tamsulosin) is in a group of drugs called alpha-adrenergic blockers. Flomax (tamsulosin) relaxes veins and arteries so that blood can more easily pass through them.

Flomax (tamsulosin) also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Flomax (tamsulosin) is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

In 2006, the U.S. Food and Drug Administration has ordered the makers of Flomax, the most commonly prescribed drug to treat benign prostatic hyperplasia (enlarged prostate), to change the label to reflect the possibility that the drug is linked to a condition that can complicate cataract surgery.

In 2007 Ranbaxy Laboratories’ Canadian subsidiary received marketing approval for the generic version of Flomax.

The Canadian market, for both the generic and the registered version of the drug (Flomax), is estimated at Canadian $22 million, according to Ranbaxy.

Flomax is a registered trademark of Boehringer Ingelheim in Canada.

Ranbaxy reached an out-of-court settlement with the Japanese company Astellas and the US subsidiary of Boehringer Ingelheim (BIPI) with regards to the billion dollar plus drug Flomax.

In November, Ranbaxy launched generic version of the blockbuster anti-viral valaciclovir pills in the US.

Valaciclovir is the therapeutically equivalent version of Valtrex by GlaxoSmithKline Pharmaceuticals.

Ranbaxy has a ‘First To File’ status for valaciclovir and hence the company is likely to get six months – or 180 days – of exclusive marketing rights for the $2 billion drug valaciclovir with no apparent authorised generics in sight atleast during the exclusivity period, reports said.

Recently, Indinavir, anti HIV drug from Ranbaxy Laboratories Limited has been included pre-qualification list of the World Health Organisation, Geneva (WHO).

Daiichi-controlled Ranbaxy Laboratories Ltd has posted a third-quarter profit before tax at USD 33 Mn (Rs. 1,601 Mn) with an EBITDA margin of 13% to sales for the quarter ending on September 30, boosted by earnings fro emerging market sales including India and South Africa.

Net income was 1.17 billion rupees ($25 million) compared with a year-earlier loss of 3.95 billion rupees.

Sales in India, South Africa and other emerging markets contributed for 62 percent of Ranbaxy’s revenue.

Developed markets de-grew by 30%, primarily on account of loss of sales in USA because of the import alert and Application Integrity Policy imposed by the USFDA.

North American region recorded sales of USD 61 Mn (Rs. 2,955 Mn) during the quarter, a de-growth of 43%.

In USA, sales during the quarter were USD 44 Mn (Rs. 2,138 Mn), a de-growth of 53% over Q3’08. This was primarily on account of ongoing USFDA issues and the discontinuation of omeprazole authorized generic.