Wockhardt has withdrawn its paragraph IV abbreviated new drug application (ANDA), filed with the USFDA for the marketing rights for Allegra, the world?s best selling anti-allergic drug.
The move, coming in line with a spate of out-of-court settlements between MNCs and Indian pharma companies, follows a patent infringement suit filed by Aventis Pharmaceuticals, the patent holder of Allegra, last month at the New Jersey district court. If Wockhardt had won the patent litigation, they could have gained a 180-day marketing exclusivity to sell a copy of the $931 million drug in the US.
It was on November 26 that Aventis filed a suit against Wockhardt USA Inc alleging that the generic version of Allegra that was to be launched by Wockhardt would infringe the patents for fexofinadine hydrochloride, the major ingredient in Allegra. In October, Aventis had also sued Dr Reddy?s Labs for alleged infringement of the Allegra patent.
Acknowledging the development, a Wockhardt spokesperson said, ?The paragraph IV filing for fexofenadine was done in June 2007 and the company has now decided to go in for para III filing.? However, he refused to disclose anything further. According to USFDA norms, para III allows a company to market copycat when the listed patent expires.
In a similar move, last week, Sun Pharma had executed a settlement with Novartis, agreeing not to market generic Exelon in the US until sometime prior to the expiration of the patents covering Exelon.
According to experts, the increasing legal costs for patent litigations are compelling Indian generic firms to prefer out-of-court settlements. Sujay Shetty, associate director, PricewaterhouseCoopers Pvt Ltd, said, ?The litigation process is quite expensive. Also, the risky move remains unattractive to investors which reflects in the performance of the concerned company’s stock.?
According to legal sources in the US, a drug patent challenge easily consumes $15 million in legal fees and expenses.
In July , Ranbaxy and GlaxoSmithKline (GSK) had decided for settling out of court their patent battle over the $1.3-billion drug, Valtrex, while Dr Reddy?s had settled a litigation with GSK over Imitrex last year, after being offered the rights to launch the authorised generic.