Ranbaxy Laboratories has received a Paragraph IV Certification Notice of filing from Watson Laboratories of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration for a generic version of Absorica (isotretinoin capsules), a product that is licensed from Cipher Pharmaceuticals (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 will 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.
EP News Bureau – Mumbai