Sun Pharma launches generic version of Novartis' anti-leukaemia drug Gleevec in US

In 2015 the product had total sales of US$4.5bn globally and $2.5bn in the US, according to IMS data

Sun Pharmaceuticals has launched a generic version of a top selling drug with 180 days’ sale exclusivity in the US market. The product launch is expected to boost the firm's US business, which has been hit by fewer approvals as well as regulatory compliance issues.

The firm has launched a generic version of Novartis’ anti-leukaemia drug Gleevec after receiving US FDA approval in December last year. The product had total sales of US$4.5bn globally and $2.5bn in the US, according to IMS data.

Meanwhile, EnvoyHealth, a Diplomat company, is set to support a patient assistance call centre programme for Sun Pharma's imatinib mesylate in the US. The programme intends to create swift patient access to affordable medication and to enhance therapy adherence. Imatinib mesylate is a kinase inhibitor used to treat adults and paediatric patients with Philadelphia + chronic myeloid leukaemia.

Sun Pharma's imatinib mesylate is FDA approved as bioequivalent and therefore therapeutically equivalent to Gleevec for the approved indications. The company had reported a drop in revenue from the US market in the second quarter of FY 2016. The US market accounts for 40% of total revenue for the firm.

Under the terms of a settlement agreement with Novartisw, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the US

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

'Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the US,' the company said.

Novartis’s US patent for the drug expired last July. The Sun Pharma subsidiary was the first-to-file an Abbreviated New Drug Application (ANDA) for a generic Gleevec with a Para-IV certification. Sun gets half its overall revenue from the US.

Growth in the US for Sun Pharma will be mainly driven by the launch of innovative speciality products and lower impact from patent expirations.

Implementation of the Affordable Care Act (also known as Obamacare) may have a positive impact on demand for medicines but increase pressure on payers who fund medicine consumption, the company said.

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