Jason Napodano, CFA
Research analyst, medium-term horizon, biotech, small-cap

Ranbaxy Receives Paragraph IV Certification On Absorica, Panic Ensues

On September 19, 2013, Cipher Pharmaceuticals (CPHMF.PK) (DND.TO) announced that U.S. sales and distribution partner for Absorica, Ranbaxy Laboratories (OTC:RBXZF), has received a Paragraph IV Certification Notice of filing from Watson Laboratories, a division of Actavis plc (ACT), of an abbreviated new drug application (NASDAQ:ANDA) for a generic version of Absorica (CIP-isotretinoin capsules). 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. But before we get into the details of the filing and how it impacts Cipher's valuation, investors may be curious - What exactly is a Paragraph IV Certification anyway?

A Little Background On ANDA's, Paragraph IV Challenges, and Hatch-Waxman...

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