Purdue Pharma sues Ranbaxy on generic OxyContin (oxycondone) patent rights in US

OxyContin was the ninth most-selling drug in the US in 2008 with sales of $2.5 billion

Ranbaxy has been sued by Purdue Pharma for allegedly infringing one of its valid patents on OxyContin (oxycondone) extended release formulation by seeking approval to market a generic version of the pain drug in US.

Ranbaxy has violated Purdue Pharma’s U S patent number 5,508,042 (’042) covering OxyContin formulations listed in US FDA’s Orange Book, Purdue Pharma alleged in its lawsuit filed in the United States District Court for the Southern District of New York on 20th October.

PUrdue Pharma’s ‘042 patent entitled “Controlled Release Oxycondone Compositions”, which was issued on 16th April, 1996 covers a method for substantially reducing the range in daily dosages required to control pain in approximately 90% of patients whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt of is administered to a patient.

Ranbaxy submitted abbreviated new drug application (ANDA) No.78-093 to the US FDA under Section 505(j) of the Federal Food, Drug and Cosmetics Act seeking approval to commercially manufacture and sell oxycondone hydrochloride extended release tablets before the expiration of ‘042 patent, Purdue argued.

Ranbaxy submitted ANDAs for tablets in strengths of 10,15,20,30,40,60,80 milligrams that contain oxycondone as active ingredient.

In its lawsuit, Purdue Pharma appealed the court that Ranbaxy should not be permitted to either manufacture or market the oxycondone generic pills in US as it amounts to the violation of its patent ‘042.

What is OxyContin?

OxyContin contains active ingredient oxycondone, an opioid analgesic synthesized from opium-derived thebaine. Oxycondone is a legal narcotic (or a controlled substance) that is available, by prescription, to treat severe pain.

OxyContin is a controlled-release medication that, when used correctly, provides extended relief of pain associated with cancer, back pain, or arthritis.

However, often when the drug is abused, the tablets are crushed and snorted, chewed, or mixed with water and injected- eliminating the time-release factor and allowing for a quick and intense rush to the brain. This practice can lead to overdosing on OxyContin’s active ingredient, oxycodone, by releasing too much of the medication into the bloodstream too quickly.

OxyContin is highly addictive.Illicit users of the drug have risen drastically and steadily over the last few years.OxyContin is also known as Oxy, OxyCotton, Oxy 80 (for the 80mg dose), or OC.

Oxycondone is also found in pills Percoset, Percodan, Roxicodone, OxyIR, Endocet, Tylox, Roxicet, Roxiprin and Combunox.

OxyContin is the top-selling prescription painkiller.

OxyContin was the ninth most-selling drug in the US in 2008 with sales of $2.5 billion, a staggering 140 per cent over the previous year, according to data collated by Verispan, a healthcare information company.

In May 2007,A US federal court in West Virginia has ordered Purdue Pharma to pay $634 million in settlement to defendants in claims of illegal use of OxyContin drug.

Purdue also acknowledged that its “fraudulent conduct caused a greater amount of OxyContin to be available for illegal use than otherwise would have been available.”

The court also sentenced three top executives of Prude Pharma that makes the narcotic to three years” probation and 400 hours each of community service in drug treatment programmes.

Stamford, Conn-based Purdue Pharma acknowledged that its staff had violated prescription requirements for its OxyContin painkiller.

Again on October 4, 2007 Kentucky officials sued Purdue because of widespread Oxycontin abuse in Appalachia. A lawsuit filed by Kentucky Attorney General Greg Stumbo and Pike County officials demands millions in compensation from drug maker Purdue Pharma.

Purdue has been settling patent infringement lawsuit on OxyContin with several generic companies, so far including Endo, Teva, Impax and Mallinckrodt.

In April, Indian generic maker Sun Pharma received US FDA approval to market Roxicodone (oxycodone) hydrochloride tablets in the strength of 5mg, 15mg and 30mg.

Of late, US FDA has issued warning letters to seven APIs and 30 generic drugs (sterile and non-sterile) of RLL, manufactured at its Dewas and Paonta Sahib manufacturing facilities for non-confirming to cGMP norms.

Ranbaxy Laboratories Ltd, in which Japan’s Daiichi Sankyo owns about 64 percent, has been incurring huge losses following the US FDA action.

However, Ranbaxy posted a quarterly profit before tax at USD 33 Mn (Rs. 1,601 Mn) with an EBITDA margin of 13% to sales for the quarter ending on September 30, boosted by eranings fro emerging market sales including India and South Africa.