Cadence Faces Competition from Generic Pain Reliever, Less Than a Year After FDA Approval

Xconomy San Diego — 

San Diego-based Cadence Pharmaceuticals (NASDAQ: CADX) won FDA clearance in November to start selling the first intravenous form of a common pain reliever, and it’s already attracting competition from a generic rival.

The FDA’s website was updated today to show that another company is seeking to sell a generic version of injectable acetaminophen, which Cadence markets under the brand name Ofirmev. The FDA website didn’t disclose the name of the company seeking to bring the generic treatment to the market. Cadence, in a regulatory filing, noted that its drug is covered by two patents. The product in question here is different than the acetaminophen tablets you can find at every corner drugstore, marketed under the name Tylenol.

“We firmly believe in the strength of our patents. We anticipated challenges and are prepared to vigorously defend our intellectual property rights to Ofirmev,” said Cadence CEO Ted Schroeder, in an e-mailed statement.

No doubt, Cadence has good reason to gear up for a legal battle to defend its patents. Its reformulated version of acetaminophen, used in hospitals, is the company’s only product that is currently available for sale on the U.S. market. Cadence has positioned the new drug as an option for hospital-based patients who can’t take oral pain relievers, and as an alternative to opioid-based narcotic pain relievers that can be addictive and cause side effects, like chronic constipation. Cadence has reported strong initial demand from hospitals for the product. The company has said it expects its drug to win a spot on the preferred drug lists of 1,000 to 1,200 hospitals by year’s end, compared with its original forecast of 800 to 1,000 hospitals.