Pharma major Sun Pharmaceutical Industries on Thursday said it has settled a litigation issue with the Basel-based Novartis Pharmaceuticals Corporation over the launch of generic version of the laters patented leukemia drug, Gleevec, in the United States.
Under the settlement, Sun Pharma's US subsidiary may launch a generic version of Gleevec in the US on February 1, 2016, though the agreement is subject to customary regulatory approval.
According to analysts, the agreement will help Sun Pharma generate sales of $160 million and a profit of $95 million during the first six months of the launch.
In a statement to the Bombay Stock Exchange, Sun Pharma said that one of its subsidiaries has executed a settlement with Novartis Pharmaceuticals Corporation stipulating a dismissal of the lawsuits filed in the US against the company regarding submission of an Abbreviated new Drug Application (ANDA) for a generic version of Gleevec, imatinib mesylate tablets.
Gleevec is a blockbuster product of Novartis with annual sales in the US estimated at $2 billion in 2013. Sun Pharma has a tentative approval from the US Food and Drug Administration (USFDA) for its ANDA for generic version of Gleevec. The tablets are indicated for treatment of chronic myeloid leukemia.
In a separate press statement, Novartis said, the company has settled its litigation with the US subsidiary of Sun Pharma relating to Novartis patents covering the use of certain polymorphic forms of Gleevec which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec expires in the US on July 4, 2015. Sun Pharma's subsidiary has received tentative approval from the USFDA for its generic version of imatinib mesylate. Under this settlement, Novartis will get seven more months without competition from Sun Pharma.
However, none of the companies disclosed any further information saying that terms of the settlement agreement are otherwise confidential. The other terms of the agreement are confidential. The agreement is subject to customary regulatory approvals.
According to Reuters, Novartis is looking to plug the hole left by the upcoming expiration of its patent for Gleevec with other treatments, as well as stave off generic competition to the lucrative drug for as long as possible. Sun Pharma, in this case, is the most tangible threat to the Novartis' drug.
"Sun Pharma had a first-to-file with Para IV certification filing in this particular drug, challenging the patent of Novartis in the US. However, it seems like both companies have gone for an out-of-court settlement.
This drug also seems to be a limited competition drug," said a city-based pharma analyst.
If a generic company is the first-to-file its ANDA with a Paragraph IV certification and prevails in the subsequent lawsuit, that generic company is granted a period of market exclusivity of 180 days.
"Sun Pharma has the sole first-to-file advantage with 180-days marketing exclusivity. This mean the company will be have almost 40% market share," said another pharma analyst.