Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versions of the world's largest selling sleep disorder drug, Ambien (Zolpidem Tartrate).
The drug became off-patent on April 21, 2007. Owned by Sanofi-Aventis, Ambien is the 13th largest branded drug with total annual sales of $ 2.12 billion (IMS: Dec. 2006).
First generics are drugs that have never been approved before as generic and are new generic products to the marketplace. Limited competition and comparatively less price erosion helps generic manufacturers to get more margins in the case of first generic. In the case of Ambien, the price erosion could be about 80 per cent, said analysts.
The FDA had tentatively approved Ranbaxy's generic version of the drug a few weeks ago. Ranbaxy's plans are to manufacture the product at the company's Ohm Laboratories facility, based in North Brunswick, New Jersey. A company spokesperson said the company would soon decide on launch of the product.
"This is our first sedative-hypnotic product and we are pleased that this will complement our current portfolio. We plan to launch this product to the market immediately. This will bring our total product selection to 29 different products represented by 65 various strengths," said Daniel H Movens, Caraco's chief executive officer, in a press statement.
Dr Reddy's has already shipped the product to the US and plans to launch the drug immediately. "Pricing will be decided depending on the competition in the market as there are several players and depending on the prices of those who first enter the market. We are ready to grab a good share of the market," said a Dr Reddy's spokesperson.
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia and related disorders and the drug had sales of about $ 659 million in the US, based on an IMS sales data for the twelve months ended February 2007.
Besides Ranbaxy, Dr Reddy's and Caraco, the FDA gave approval for Zolpidem tartrate tablets in five milligrams and 10 milligrams to Mylan, Teva, Roxane Lab, Watson Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical, Carlsbad Technology and Lek Pharmaceuticals.