Two generic versions of OxyContin approved

This article was originally published on March 25, 2004.

Two pharmaceutical companies with major operations in the Philadelphia area have won regulatory approval to sell generic versions of the potent painkiller OxyContin, a drug that helps patients with severe chronic pain but has been linked to drug abuse as well.

Endo Pharmaceuticals Holdings Inc., in Chadds Ford, and Teva Pharmaceutical Industries Ltd., with its U.S. headquarters in North Wales, have received clearance from the Food and Drug Administration for their respective generic dosage strengths of oxycodone hydrocholoride extended-release tablets.

But a patent dispute with the OxyContin brand-name manufacturer, Purdue Pharma L.P., is likely to delay less-expensive generic versions from reaching pharmacy shelves for more than a year.

Officials at Endo and Israel-based Teva declined yesterday to say when they might launch their products.

Endo has 180 days of marketing exclusivity on 10-milligram, 20-milligram and 40-milligram generic versions of OxyContin. Teva has 180 days of marketing exclusivity on an 80-milligram generic OxyContin.

“We are not disclosing any launch plans at this stage,” said George S. Barrett, president and chief executive officer of Teva Pharmaceuticals USA in North Wales.

Said Endo spokesman Bill Newbould: “We are evaluating all our options. We’ll consider all the appropriate risks and rewards of launching prior to the appellate court decision.”

About 63 percent of OxyContin U.S. sales, or $1.2 billion, are from the three strengths Endo wants to sell, Newbould said. The 80-milligram dose that Teva has been approved to market has annual brand sales of about $700 million, Teva said in the statement.

Teva, the world’s largest manufacturer of generic medicines, and Endo, the maker of Percocet painkillers, said they had not decided the prices for the generic versions. Generic drugs usually sell for one-third to one-half of the brand-name drug’s price.

As a condition to FDA approval, Teva and Endo must include a prominent label warning that OxyContin is an opioid as addictive as morphine. The label also must caution that the tablets should not be chewed, snorted, crushed or injected because rapid release and absorption can be potentially fatal.

The FDA required the generic manufacturers to have risk-management plans, before selling the drug, including education and training for physicians, and monitoring to detect suspicious prescriptions patterns and individuals who redeem prescriptions from multiple physicians. In 2002, a Bucks County physician was sentenced to at least 30 years in prison for flooding the Philadelphia region with hundreds of illicit prescriptions for OxyContin.

Analyst Angela Larson for Citigroup Global Markets said in a note to clients that sales of generic OxyContin for Endo during the first 180 days, or six months, of U.S. market exclusivity could amount to $294 million. For the second six months after other generic-drug competitors enter the market, Larson estimated that Endo generic OxyContin sales would be $144 million.

Generic OxyContin would be Endo’s biggest product, surpassing sales of its pain treatment Lidoderm, which is expected to have $300 million in sales this year, Newbould said.

The FDA said in a statement that OxyContin is used to treat moderate-to-severe chronic pain from cancer and other illnesses, and FDA approval of the generic products “should make this safe and effective medicine available at a lower cost to patients.”

The FDA said it was seeking to balance effective pain management for more than 10 million Americans who suffer chronic pain with the potential for abuse.

Agency officials said that generic versions of drugs did not increase overall use of the medication. “Rather, demand tends to remain steady, with an increasing proportion of market share being held by the generic versions,” the FDA statement said.

Purdue Pharma lost a federal patent-infringement case against Endo in January. Purdue has appealed.

“We are confident that once the court of appeals reviews the record, they will overturn the lower court’s ruling and find our patents are enforceable,” said Robin Hogen, Purdue Pharma’s vice president of public affairs. Purdue said its patents were valid through 2013. An appeals court decision could take 12 to 18 months, Endo’s Newbould said.

Endo shares closed up $2.55, or 12.7 percent, to $22.68 in Nasdaq Stock Market composite trading. Teva closed up 56 cents, or 0.9 percent, to $61.80.