Sun Pharma, Lupin launch generics in US

Product launches will give boost to US businesses of two companies

Sun Pharmaceuticals and Lupin have launched the generic versions of top selling drugs with 180 days’ sale exclusivity in the US market.

The product launches will give a boost to the US business of the two companies, which have been hit by fewer approvals as well as regulatory compliance issues. Both the firms reported a drop in revenue from the US market in the second quarter of FY16. For the two companies, the US market accounts for 40-50 per cent of the total revenue.

Sun Pharma has launched the generic version of Novartis’ anti-leukemia drug Gleevec after receiving US Food and Drugs Administration (FDA)’s approval in December last year. The product had total sales of $4.5 billion globally and $2.5 billion in the US, according to IMS data. Sun Pharma has 180-day exclusivity to distribute the product in the US.

Sun Pharma had applied for the product launch from its Halol plant, but following FDA’s adverse observations on the plant, it shifted the manufacturing of tablets to a site in the US.

The company has also launched a campaign to make its drug more popular among doctors and patients with a patients-access programme and a helpline.

Meanwhile, Lupin has said it has launched the generic version of Valeant Pharmaceuticals’ diabetes drug Glumetza.  The company has 180-day exclusivity for the product, which had sales of $450 million in the US. The firm said it had launched 10 products in the US and received approvals for 21 products.

Lupin had secured the right to sell the generic version of Glumetza following a settlement with Santarus Inc in 2012, which owned the drug then. Later, in 2013, Santarus sold the diabetes drug to Salix Pharmaceuticals. In 2015, Salix was acquired by Valeant Pharmaceuticals.

BOOSTER DOSE

• Sun Pharma has launched the generic version of Novartis’ anti-leukemia drug Gleevec after receiving USFDA’s approval in December last year
   
• The product had total sales of $4.5 billion globally and $2.5 billion in the US, according to IMS data
   
• Lupin has said it has launched the generic version of Valeant Pharmaceuticals’ diabetes drug Glumetza
  

 

The company has 180-day exclusivity for the product, which had sales of $450 million in the US