Ranbaxy Laboratories fell 5.28% to Rs 332 at 10:03 IST on BSE after the company said it received a Paragraph IV certification notice of filing from Watson Laboratories Inc. for a generic version of Absorica.
The company made the announcement after market hours on Thursday, 19 September 2013.
Meanwhile, the BSE Sensex was up down 28.08 points, or 0.14%, to 20,618.56
On BSE, 8 lakh shares were traded in the counter compared with average volume of 7.22 lakh shares in the past one quarter.
The stock hit a high of Rs 340.95 and a low of Rs 302 so far during the day. The stock hit a 52-week low of Rs 253.95 on 2 August 2013. The stock hit a 52-week high of Rs 559.80 on 8 November 2012.
The stock had underperformed the market over the past one month till 19 September 2013, falling 7.90% compared with the Sensex's 12.78% rise. The scrip had also underperformed the market in past one quarter, sliding 1.03% as against Sensex's 7.28% rise.
The large-cap company has an equity capital of Rs 211.56 crore. Face value per share is Rs 5.
Ranbaxy Laboratories Inc, the US-based wholly-owned subsidiary of Ranbaxy Laboratories, has received a Paragraph IV certification notice of filing from Watson Laboratories Inc of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for a generic version of Absoric (isotretinoin capsules), a product that is licenced from Cipher Pharmaceuticals Inc of Ontario, Ranbaxy Laboratories said in a statement.
Ranbaxy Laboratories Inc is a sales and distribution partner with Cipher Pharmaceuticals Inc.
A company files for a Paragraph IV certification when they contest that the patent on the original drug is either invalid or unenforceable or that the generic version that they intend to manufacture will not infringe on the listed patents.
The company's statement said that Ranbaxy and Cipher intend to vigorously defend Absorica's intellectual property rights and pursue all available legal and regulatory pathways in defense of the product.
It added 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, Ranbaxy's statement said.
On 17 September 2013, Ranbaxy announced that the US FDA that imposed an import alert on the company's Mohali facility. The US FDA also advised that the Mohali facility will be subject to certain terms of the Consent Decree signed in January 2012.
The company said it will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest.
The US FDA had conducted inspections at Ranbaxy's Mohali facility in 2012, resulting in certain observations. The Company believes that it has made further improvements at its Mohali facility since the last inspection in 2012, and remains committed to addressing all concerns of the US FDA. Ranbaxy said it was hopeful of an early resolution of these concerns.
Ranbaxy said it was fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the company. Ranbaxy said it stayed firmly committed to its philosophy of 'Quality and Patients First'.
The Mohali plant manufactures oral solids for export to the US, the European Union and other geographies.
In May 2013, Ranbaxy Laboratories agreed to pay $500 million penalty to the US government to settle criminal and civil charges related to drug safety.
Ranbaxy Laboratories reported consolidated net loss of Rs 524.24 crore in Q2 June 2013, lower than net loss of Rs 585.72 crore in Q2 June 2012. Net sales declined 17.8% to Rs 2633.20 crore in Q2 June 2013 over Q2 June 2012.
Ranbaxy Laboratories is an integrated, research based, international pharmaceutical company producing a wide range of generic medicines. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group.
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