Summary
Sun Pharma can greatly benefit from the nationwide shortage of Oxycodone Immediate Release Tablet, by getting approval from the FDA on their own generic. With recent recalls from different manufacturers, and the shortage of a comparable product Morphine Sulphate, the FDA currently estimates that return to normal supply levels of Oxycodone may occur in approximately 2 months, during which time Sun Pharma can capitalize on the shortage by securing longer term contracts with wholesalers.
Analysis
Generic approvals by Indian manufacturers is an increasing trend. With the vertical acquisition of Chattem Chemicals, a leading provider of control substances bulk chemicals, Sun Pharma becomes one of the first Indian manufacturer to enter the area of schedule II controlled substances
Oxycodone (immediate release) tablets are a staple with many patients who need more immediate relief, and it is usually used in conjunction with other longer acting products as Duragesic (Fentanyl patches) or OxyContin (Oxycodone extended release tablets), to name a few. As per Drug Topics, Oxycodone had retail sales of over $256,000,000 in yearly sales in 2007.
Recently, two manufacturers, Actavis Totowa and Ethex have had recalls issued with their Oxycodone IR (immediate release), which creates a substantial opportunity for Sun Pharma to ramp up on its sales of its newly approved Oxycodone IR. Additionally, the FDA has released that they are "working with manufacturers to help them increase manufacturing in order to meet demand. The firms are producing and shipping as product becomes available."
Additionally, for short and immediate term extreme pain relief, another schedule II control substance used is Morphine Sulfate. Additionally, there have been recent recalls in this category also. Last, the FDA on March 30, 2009, filed an action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, including many Morphine Sulfate dosage forms.
Both of the above occurrences will boost the value of Oxycodone tablets. The current manufacturers, Mallinckrodt, and the future manufacturer, Sun Pharma can capitalize on this event.
Aemad A. Aslam
MindPharma
