Global Pharmaceuticals, the generic division of Impax Laboratories, Inc. (IPXL), a specialty pharmaceutical company, recently started shipping its generic version of Endo Health Solutions’ (ENDP) Opana ER (oxymorphone hydrochloride).
Opana ER is approved for relief from moderate to severe acute pain in patients who are in need of continuous, opioid treatment for an extended time period.
Back in June 2010, Impax entered into a settlement agreement with Endo regarding its generic version of Opana ER. As per the terms of the deal, Endo granted Impax the license to sell generic version of Opana ER from January 1, 2013.
We note that apart from Impax, the patent on Opana ER has been challenged by many companies, namely Sandoz, the generic division of Novartis (NVS), Teva Pharmaceuticals (TEVA), Watson Pharma (WPI), Actavis, Roxane Laboratories and Ranbaxy. The company has settled all disputes apart from the one associated with Ranbaxy, which Endo has decided not to challenge. Consequently, Ranbaxy can sell the generic versions of Opana ER from September 9, 2013.
Per the settlements with all other challengers, they have agreed not to challenge patents relating to Opana ER. Actavis launched the generic version of non-tamper resistant formulation of Opana ER (7.5 and 15 mg dosages) on July 15, 2011. Sandoz, Teva, Watson, Roxane and Actavis can sell all doses of the generic version of non-tamper resistant Opana ER from July 1, 2013. Ranbaxy is expected to launch its generic version on September 9, 2013.
We currently have a Neutral recommendation on Impax. The stock carries a Zacks #3 Rank (Hold) in short run.
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