After Ranbaxy, three more domestic pharmaceutical companies – Lupin, Aurobindo Pharma and Jubilant Life Sciences – have received final approval from the US drug regulator to sell generic valsartan in the US market.
The drug is used to treat hypertension and to lower blood pressure.
The product falls under the therapeutic category of CVS (cardiovascular) and has a market size of approximately $2 billion for the 12 months ended October 2014 according to IMS data.
While Lupin has already launched the product in the US market, Jubilant Life Sciences plans to launch the product immediately. Aurobindo is also ready to launch the drug, it said in a statement.
Lupin said its subsidiary Lupin Pharmaceuticals Inc has launched valsartan tablets USP, the generic version of Novatis's Diovan, in multiple strengths of 40 mg, 80 mg, 160 mg and 320 mg, having received final approval from the US Food and Drug Administration (FDA).
Jubilant Life Sciences said it has received abbreviated new drug application (ANDA) final approval from the FDA for valsartan tablets in similar strengths and the company expects to launch the product immediately. Hyderabad-based Aurobindo Pharma in its statement said it has also received final approval from the FDA to manufacture and market the drug, and the product is ready for launch.
On Monday, Mylan Inc announced that it has launched the drug after receiving final drug regulator's approval.
Gurgaon-based Ranbaxy launched the drug in the US market last July after it received approval from the FDA. The company was earlier supposed to launch the drug in 2012 but the approval was delayed by the US drug regulator. The company enjoyed an 180-day exclusivity to sell the cheaper version of the drug and estimates point to a sales revenue of $220-230 million during the first six months.
Hitesh Mahida, pharma analyst with Antique Stock Broking, said, "Ranbaxy possibly has made around $220-230 million during the first six months of exclusivity. But now there would be a 90-95% price erosion. So with more players to enter the market, Ranbaxy's overall revenue from this drug may not be more than 10%. I believe the market for valsartan has shrunk to $1.3-1.4 billion due to significant price erosion in that market post Ranbaxy's launch.
So now with around 10 players including the innovator and Ranbaxy, the market is likely to shrunk further by at least 90%. All the existing players will see drop in their market shares with the innovator likely to lose more. Jubilant and Aurobindo are likely to keep the prices of the generic very low once they launch the product."
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}