Glenmark has settled its litigation with Daiichi Sankyo Inc and Genzyme Corporation over the sale of Glenmark's generic version of Colesevelam Hydrochloride in the US.
This is the sixth settlement in less than two years for the company.
Daiichi Sankyo markets Colesevelam Hydrochloride as a powder for oral suspension and as a tablet under the Welchol brand name, to treat cholesterol and type-2 diabetes mellitus.
Daiichi Sankyo and Genyzme filed a patent infringement suit in November 2010 in the US District Court for the District of Delaware seeking to prevent Glenmark from commercialising its Abbreviated New Drug Application (ANDA) prior to expiration of the patent, Glenmark said. An ANDA filing in the US allows a drug company to sell the product, on getting regulatory approval.
Glenmark has received a licence from Daiichi Sankyo and Genzyme that will permit Glenmark to launch its generic colesevelam hydrochloride products on April 2, 2015, or earlier under certain circumstances, the Mumbai-based drug-maker said.
Industry estimates put sales for the year ended December 2010 at about $51 million for the oral suspension and $327 million for the tablet.
Companies that make generic versions of innovative drugs settle litigations with the innovator in a bid to save on litigation cost.
In this case, the settlement could save about $5 million in litigation cost, said a source close to the development, as there was another generic player also making a similar version of Daiichi's product.
Settlements could benefit the consumer, the source pointed out, as a generic version (less expensive than the innovator's drug) will hit the market between three and six months from when the patent would have expired.
So the consumer gets a less expensive drug a little sooner, the generic company saves on litigation cost and gets a few months of exclusivity and the innovator gets to keep a large part of exclusive patent-protected period, save the last six months, the source said.
This May, Glenmark had formalised a settlement and licence agreement with US-based Nycomed to resolve patent infringement lawsuit for fluticasone propionate lotion, used for treating skin pain and itch.
Last August, it had entered into an agreement to resolve a patent-related suit with Sepracor Inc over its insomnia drug, Lunesta, estimated then to have clocked sales of $741 million.
Glenmark had settled with Merck in May last year, over its $1.4-billion, cholesterol-modifying drug, Zetia. Another settlement for the company was with GlaxoSmithKline in April, over malaria treatment tablet Malarone.
In the cases of Malarone and Zetia, Glenmark had the first-to-file status — where it was the first generic drug-maker looking to sell its version of the original drug in the US.
In November 2009, Glenmark had settled with Medicis Pharma, over derma products – Flucocinomide and Ciclopirox Olamine.
Glenmark shares closed down over one per cent at Rs 312 on the BSE on Monday.