Ranbaxy’s silence on Provigil copy vexes St

Despite settling a litigation with innovator Cephalon, Ranbaxy has not been able to launch the generic version of Provigil (modafinil) in the US, casting a shadow on its ability to monetise first-to-file (FTF) opportunities.

Provigil (modafinil) is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to a variety of reasons including obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder, or narcolepsy.

According to its settlement agreement with Cephalon, Ranbaxy was expected to launch modafinil in the US this month. But the company is yet to reinforce its FTF status on the drug.

Sources said commercialisation of Provigil, which has sales of about $1.1 billion a year, is posing challenges.

Apart from Ranbaxy, Israel’s Teva and US-based generics giants Mylan and Barr Laboratories too had settled patent disputes with Cephalon.

With Teva having been accorded exclusivity by FDA on April 5 and exclusivity having started from March 29 (the date of launch of authorised generic version), it is strange that Ranbaxy has not taken any step to protect its FTF like Mylan has.

Mylan sued the US Food and Drug Administration on April 5 seeking a ruling that Teva holds no exclusivity for generic Provigil.
Ranbaxy’s position begs the question whether it would be able to launch this product after the 180-day exclusivity gets over in September.

“We believe the loss of FTF status is a key risk to the stock as post-FTF sales are critical to recovery of business in the US,” said Priti Arora, analyst with Kotak Institutional Equities Research, in a note.

The scepticism is extending to other FTFs of Ranbaxy, particularly the generic Actos (pioglitazone).

The pharma major had earlier settled a dispute with the Japanese Takeda Pharmaceutical Company to market the generic version of the diabetes drug in the US. As per the settlement agreement, it is to launch the drug in the US on August 17 .