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Ranbaxy forfeits exclusivity on generic Provigil Posted 17/08/2012

As part of Ranbaxy’s consent decree with FDA, signed in January 2012, the Indian generics major had to agree to relinquish 180-day marketing exclusivity on three pending generic drug applications [1]. Now analysts believe that generic Provigil (modafinil) may have been one of those undisclosed drugs.

Analysts now say that Teva’s blockbuster Provigil, which is used to treat daytime sleepiness and obstructive sleep apnea, is one of these three drugs. The conclusion is based on the fact that Ranbaxy has not acted on its 180-day marketing exclusivity for the drug, despite the fact that US-based Par Pharmaceuticals launched its generic version on 6 April 2012.

Teva picked up Provigil in 2011 after the generics giant acquired Cephalon as part of a move into brand-name medicines.

Provigil had US annual sales of US$1.2 billion, according to IMS Health. This means that Ranbaxy could have earned US$50–100 million in revenue from the sale of its generic equivalent of Provigil during the six-month marketing exclusivity period in which the Indian drugmaker’s generic drug would have been the only competitor to the blockbuster drug.

Earlier in 2012, Ranbaxy CEO, Mr Arun Sawhney said that the forfeiture would not have significant financial impact on the company, which seems to be holding true. The company reports that progress on the implementation of the consent decree has been per plan and has posted healthy sales growth of 55% in the second quarter of 2012 despite any losses due to loss of exclusivity. The increase in sales growth has been helped by US sales of generic atorvastatin and atorvastatin+amlodipine, in which Ranbaxy achieved a 50% market share during its 180-day exclusivity and has maintained a strong share post-exclusivity.

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1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy consent decree with FDA submitted to court [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Aug 17]. Available from: www.gabionline.net/Generics/News/Ranbaxy-consent-decree-with-FDA-submitted-to-court

Source: Ranbaxy, The Economic Times India

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