Watson Files ANDA for Ranbaxy's Absorica
RANBAXY RECEIVES PARAGRAPH IV CERTIFICATION
Gurgaon, India, Sept. 19, 2013 - Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited, today announced that the company has received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for a generic version of Absorica™ (isotretinoin capsules), a product that is licensed from Cipher Pharmaceuticals Inc. (TSX: DND) (”Cipher”) of Mississauga, Ontario.
RLI and Cipher intend to vigorously defend Absorica’s intellectual property rights and pursue all available legal and regulatory pathways in defense of the product. Absorica is currently protected by two issued patents listed in the FDA’s Approved Drug Products List (Orange Book), which expire in September 2021. RLI 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.
About Ranbaxy Laboratories Inc.
Ranbaxy Laboratories Inc. (RLI) is a U.S. based wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL). RLI is focused on the promotion of branded prescription products in the U.S. RLI has been expanding and growing on the strength of Ranbaxy’s R&D efforts, and continuing exploration of Novel Drug Delivery Systems (NDDS), licensing activities, mergers and acquisitions. RLI is expanding the visibility and presence of the Ranbaxy name by bringing value-added brand products to the market.
About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 125 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. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company’s commitment to increase penetration and improve access to medicines, across the globe.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND) is a growing specialty pharmaceutical company with three commercial products and a fourth in development. Our product candidates are typically improved formulations of successful, currently marketed drugs. We in-license a product, manage the required clinical development and regulatory approval process, and either out-license it to a marketing partner, or, in Canada, we may market the product ourselves. Our core capabilities are in clinical and regulatory affairs, product licensing, supply chain management, and marketing and sales. Since Cipher was founded in 2000, we have achieved final regulatory approval in the U.S. and Canada for all three of our original products and completed six marketing partnerships, generating growing licensing revenue.
Posted: September 2013