Ranbaxy Laboratories arm receives Notice of filing for a generic version of Absorica

20 Sep 2013 Evaluate

Ranbaxy Laboratories’ wholly owned subsidiary - Ranbaxy Laboratories Inc. (RLI), 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 (USFDA) for a generic version of Absorica (isotretinoin capsules), a product that is licensed from Cipher Pharmaceuticals Inc. (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 USFDA’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 USFDA approval of the ANDA shall then be governed by the Hatch-Waxman Act.

Absorica was approved by the USFDA in May 2012, and granted a three-year market exclusivity period, which expires in May 2015.

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