WOODCLIFF LAKE, N.J. — Par Pharmaceutical Companies Inc. has begun limited shipment of hydrocodone polistirex and chlorpheniramine polistirex (CIII) extended-release oral suspension.
The company said Tuesday that its licensing partner, Tris Pharma Inc., has received final approval from the Food and Drug Administration for its abbreviated new drug application for the generic medication (equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5 ml), which is used for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age or older.
According to Par, the oral suspension is a generic version of UCB’s Tussionex. Annual U.S. sales of Tussionex are approximately $226 million, based on IMS Health data cited by Par.
"The introduction of this first-to-market generic product will improve patient access to a much needed therapy," commented Paul Campanelli, executive vice president and president of Par Pharmaceutical. "Our partner, Tris Pharma, has once again leveraged its innovative drug delivery platform to bring this important product to market."
"We are pleased to have Par Pharmaceutical, one of the most respected generic pharmaceutical companies, as our partner in commercializing this unique opportunity," stated Ketan Mehta, president and chief executive officer ofTris Pharma.
Plans call for Par to begin shipping hydrocodone polistirex and chlorpheniramine polistirex (CIII) ER oral suspension to the trade immediately, but in limited supply due to Drug Enforcement Administration hydrocodone allocations.
Par said that in 2009, it entered into a license and distribution pact with Tris Pharma. Under terms of the agreement, Par has the exclusive right to market, sell and distribute Tris Pharma’s hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension in the United States, and Par will receive a share of the profit from the product’s sales.
