This will enable Sun Pharma’s subsidiary to launch its generic version of Gleevec in the US from February 2016. Gleevec is estimated to have annual sales of about $2 billion in the US.
The other terms of the agreement are confidential. The agreement is subject to customary regulatory approvals, stated the company.
Sun had made an Abbreviated New Drug Application (ANDA) for a generic version of Gleevec (imatinib mesylate) tablets, for the treatment of chronic myeloid leukemia (blood cancer). It subsidiary holds a tentative approval for this from the US Food and Drug Administration. Experts say Gleevec should contribute $170-200 million (with a 30 per cent price erosion and 30 per cent market share) for Sun Pharma’s total revenue in financial years 2016 and 2017, if the company gets 180-day exclusivity to sell it.
Daljeet S Kohli, head of research at Indianivesh, said, “Sun is likely to be entitled for 180 days exclusivity. Due to the complexity of the drug, not many players had adopted a Para IV filing route.” Hence, this opportunity is likely to positively impact Sun’s revenue and profitability after February 2016. A major contribution is likely to come only in financial year 2017, said Kohli.
The basis compound patent for Gleevec expires in the US on July 4 next year. However, patents covering certain polymorphic forms will expire only in 2019 (including pediatric exclusivity).
The settlement between the two companies is also expected to create entry barriers for other companies eyeing the segment. “Had Sun won the case and launched post the expiry of API patents in July 2015, it would have created an entry for subsequent filers to launch post the 180-day exclusivity. Now, the subsequent filers will have to get entry before November 2019 through a settlement with Novartis,” said a report by Credit Suisse.
Many companies had filed drug master files in the US to be able to supply raw material for Gleevec but Dr Reddy’s is the only one in active litigation. It was sued on this in February 2014.
On Thursday, shares of Sun Pharma closed at Rs 621.8, up 1.7 per cent on the BSE exchange.