Ranbaxy Laboratories Inc, the US-based wholly-owned subsidiary of Ranbaxy Laboratories Ltd, 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), the company said in an official statement on Thursday.
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.
Ranbaxy and Cipher will get about a month and half to file a patent infringement action against Watson.
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.
“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.