Did Ranbaxy give up exclusivity on copycat Provigil?

It's several months into Ranbaxy Laboratories' 180-day exclusivity on generic Provigil. But Ranbaxy hasn't launched its version of the drug. Meanwhile, Par Pharmaceuticals, which shares that exclusivity right, has reaped more than $50 million in sales off the drug. What gives?

Ranbaxy's consent decree with FDA, analysts say. In settling its longstanding manufacturing issues with the agency, Ranbaxy agreed to give up marketing exclusivity on three products. The products weren't named publicly at the time, but one of them may well be Provigil.

"The market has assumed that they have given up on the exclusivity of this product," Elara Capital analyst Surajit Pal told The Economic Times. Another unnamed analyst said, "It is quite clear. Ranbaxy won't launch its drug."

Analysts figure that Ranbaxy could have earned as much as $200 million during that six-month exclusivity period. After all, Provigil is a blockbuster with $1.2 billion in annual sales, and with only the brand and Par's version as competitors, prices wouldn't drop precipitously.

But as the Times points out, Ranbaxy officials have said none of the three forfeitures would have a "significant financial impact" on the company. Its Japanese parent Daiichi Sankyo might disagree, however; after the $500 million FDA settlement hit, executives there took a pay cut to make up for lost profits. Any financial impact going forward may feel quite significant to them.

- read the Economic Times story