As many as 15 companies across the world have lined up generic variants of Pfizer's Zoloft (Sertaline HCL), for which the exclusive six-month marketing period granted to the successful patent challenger, Teva of Israel, ends on Tuesday.
In an indication of the rising might of Indian companies in the generics space, more than half of them -- eight to be precise -- are based in the country. These are Ranbaxy, Dr Reddy's Laboratories, Cipla, Zydus Cadila, Lupin, Aurobindo, Hetero Drugs and Sun Pharma, say industry executives.
In the 12 months ended July last year, depressive disorder drug Zoloft's sales amounted to $3.1 billion in the US, according to IMS, the global health-related data house.
Teva got to launch a generic variant of Zoloft and was to be the only company to pedal a generic version for six months following June last year, when Pfizer lost its patent protection for Sertaline Hydrochloride, which is the underlying molecule.
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Teva has sought protection for its exclusivity and recently sued many potential competitors, which filed abbreviated new drug approvals for generic Zoloft, alleging that they infringed on Teva's process for making Sertaline HCl.
A win for Teva would cause the respondents to pay a significant amount as compensation. "Since we are not known to have been sued by Teva, we are likely to go ahead with the plans. We expect a feedback from our US office soon," said a spokesperson for Dr Reddy's.
A Ranbaxy spokesperson said its product launches were handled by the respective regional offices. "I am yet to get an update from our US office on the launch of Zoloft's generic version," he said.
A senior executive with Sun Pharma said the company was waiting final approval from USFDA as, at present, it only had a tentative approval.
Patent experts said Teva's attempt to sue was unlikely to deter its rivals.