Ranbaxy may spin $200 million on 180-day exclusive sales of valaciclovir generic pills: Analysts

Ranbaxy has launched generic version of the blockbuster anti-viral valaciclovir pills in the US.

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

Valtrex is indicated for treatment of the initial episode of genital herpes in immunocompetent adults.

Ranbaxy has launched 500 mg and 1 gm tablets of valaciclovir.

Valtrex has annual sales of over USD 2 billion in the US.

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.

Ranbaxy could clock in sales worth USD 200 million in the exclusivity period for valaciclovir, analysts expect.

Patent rights for Glaxo’s Valtrex is expected to be over by next month.

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

Ranbaxy Laboratories’s  Indinavir (as sulfate) – 400mg anti retroviral (ARV) capsule is used in the treatment of HIV/AIDS.

With the inclusion of Indinavir, Ranbaxy now has a total of 19 ARVs on the WHO pre-qualification list.

Ranbaxy’s ARVs, including the recently approved WHO pre-qualified products, are manufactured at the company’s state-of-the-art manufacturing facilities.

Ranbaxy has been providing ARV medicines in over 70 markets worldwide.

Ranbaxy’s ARVs have been used as mainstays in various large treatment programs, both National and NGO/Institutional.

ARV medicine produced by Ranbaxy are used by over 400000 patients worldwide , in various developing and underdeveloped countries.

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.