Ranbaxy Labs starts shipping Lipitor generic to US market

Ranbaxy Laboratories has started shipping its generic version of Lipitor from India to the US drug market. The company has started manufacturing the cholesterol lowering drug at its Mohali facility, which has recently gained approval from the US Food and Drug Administration (US FDA).

Till now, the generic drug that the company was marketing in US was being produced at its facility at Ohm Laboratories, US. Analysts said this move could help the company contain costs incurred during manufacturing of the drug and prepare it better for the fierce competition that is bound to ensue after May, once 180 days of exclusive marketing period ends for Ranbaxy.

That is the time Ranbaxy would face onslaught of competition from other generic players as Israeli generic giant Teva, US generic drugmaker Mylan, Indian rivals ? Dr Reddy?s and Lupin ? are expected to jump into the fray to grab a bite of the $7-billion Lipitor drug pie.

?The resumption of supplies from India into the US market is a significant milestone for Ranbaxy. This is a testimony to our commitment to provide quality affordable medicines to the US healthcare system. Going forward, our Mohali facility will cater to the US and other geographies, improving access to medicines, in these regions,? Arun Sawhney, managing director, Ranbaxy said.

Analysts reckon that in a scenario, where so many players compete, price erosion for this drug in the range of 80-90% is imminent. And this could be Ranbaxy?s strategy to protect its market share in the post-exclusivity period, as manufacturing in India would give it cost advantage and enable the company to slash the price points of its generic version further. Analysts, however, caution that much would depend on the capacity of the plant and the volumes that it may be shipping from India. Meanwhile, during its exclusivity period Ranbaxy has already offered deeper than usual over 60% discount to the original price of innovator Pfizer?s brand and successfully cornered the largest market share of drug in US market.

Ranbaxy?s dosage forms facility at Mohali was approved by the US FDA in October 2011. Thereafter, in the first quarter of 2012, the company received approval from the US FDA to manufacture and market Atorvastatin (Lipitor) 10mg, 20mg, 40mg and 80mg tablets. Besides US market, Ranbaxy has started selling the generic version of Lipitor in four European markets ? Germany, Italy, the Netherlands and Sweden and Australia. ?Earlier, international regulatory authorities such as the WHO-Geneva, National Medicine and Medical Devices Agency -Romania, ANVISA-Brazil, TGA-Australia, Canada Health-Canada had also approved the company?s Mohali facility,? a Ranbaxy statement said.

The new facility at Mohali will manufacture oral solid products for export to US, EU and other countries based on filings and after receiving the necessary approvals. Ranbaxy?s share price was down 2.6% on Monday since the previous close and ended at R457 at the BSE.