Roxicodone opportunity for Sun Pharma in US after narcotic painkillers recalled

Sun Pharma’s Roxicodone gets a boost as narcotic painkillers dry up in US

The Indian drug maker Sun Pharma, which secured a USFDA approval for its generic version of oxycodone stands to gain considerably from the nationwide shortage of the pain relieving drug, following recalls of some narcotic painkillers from the market.

On Monday, Sun Pharma  said it received US regulatory approval to market Roxicodone (oxycodone) hydrochloride tablets in the strength of 5mg, 15mg and 30mg.

Sun Pharma can greatly benefit from the current shortage of oxycodone immediate release tablet, and the shortage of a comparable product morphine sulphate.

As per US FDA estimates, return to normal supply levels of oxycodone can take approximately 2 months to occur. Sun Pharma can capitalise this time of shortage by securing longer term contracts with wholesalers, observers say.

Also, Actavis Totowa and Ethex recalled their oxycodone IR (immediate release),recently. This also creates a substantial opportunity for Sun Pharma to ramp up on its sales of its newly approved oxycodone IR. 

In the interim, US FDA issued a notice against morphine sulfate too, another schedule II control substance used for short and immediate term extreme pain relief. 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.

These FDA actions leave the market with little or no choices for consumers.

In addition, 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.”

Natuarally, Sun Pharma gets a boost for the value of oxycodone tablets. Apart from Sun Pharma, the only other oxycodone manufacturer is  Mallinckrodt.

USFDA had ordered 14 unapproved narcotic painkillers off the market last week as part of its crack down against unapproved prescription versions of potent morphine, hydromorphone and oxycodone.

The Food and Drug Administration told nine manufacturers to quit distributing the drugs within 90 days.

The move was part of the FDA’s years-long attempt to weed out thousands of prescription drugs that sell despite never being formally approved by the health regulatory agency. Many entered the market decades ago, before federal law required such approval. The FDA estimates that unapproved drugs account for 2 percent of all prescriptions filled.

The FDA targeted unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. Most are generic.

Following the action manufacturers including Boehringer Ingelheim Roxane Inc. of Columbus, Ohio; Cody Laboratories Inc. of Cody, Wyo.; Glenmark Pharmaceuticals Inc. of Mahwah, N.J.; Lannett Co. Inc. of Philadelphia; Lehigh Valley Technologies Inc. of Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group of St. Louis; Physicians Total Care inc. of Tulsa; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceutical Inc. of Newport, Ky.received warning letters.

FDA had found that even the approved versions of these painkillers pose a risk of serious side effects, but the unapproved products add an extra problem.

USFDA once seized $24 million worth of unapproved drugs from a company that ignored a stop-selling order. 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.

Sun Pharma has become one of the first Indian manufacturer to enter the area of schedule II controlled substances With the vertical acquisition of Chattem Chemicals, a leading provider of control substances bulk chemicals.