Ranbaxy once again top loser

Ranbaxy Labs is the big loser on the BSE currently, down 5% at Rs.333, with an intra day low at Rs.302. The stock had hit a 52-week low on 2nd Aug at Rs.253.95.

The stock is once again down as issues from US FDA continue. Fresh trouble is brewing for the company after the company stated that its US-based wholly-owned subsidiary has received a Paragraph IV certification notice of filing from Watson Laboratories Inc of an Abbreviated New Drug Application (ANDA) to the US FDA for a generic version of Absoric (isotretinoin capsules), a product that is licenced from Cipher Pharmaceuticals Inc of Ontario.

Ranbaxy and Cipher, its distribution partner intends to vigorously defend Absorica's intellectual property rights and pursue all available legal and regulatory pathways in defense of the product. Ranbaxy stated that the drug is protected by two issued patents listed in the FDA's Approved Drug Products List (Orange Book), which expire in September 2021. Ranbaxy shall take appropriate actions in response to the Paragraph IV notice letter, and FDA approval of the ANDA shall then be governed by the Hatch-Waxman Act. Absorica was approved by the FDA in May 2012, and granted a three-year market exclusivity period, which expires in May 2015.