Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced the launch of Tris-labeled generic TUSSIONEX®, an extended-release suspension containing hydrocodone polistirex and chlorpheniramine polistirex.
Tussionex®, originally approved in the early 1980's, had no generic competition until 2010 when Tris Pharma's generic product entered the market under an exclusive distribution agreement with Par Pharmaceuticals. Under the terms of the distribution agreement, Par had the exclusive right to market Tris Pharma's hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension for a five year period ending September 30, 2015. With the conclusion of the five year term, the rights have reverted back to Tris and as of October 1, 2015, hydrocodone polistirex and chlorpheniramine polistirex ER Suspension in 115ml and 473 ml bottles (compare to Tussionex®) will be marketed and distributed by Tris Pharma's generic business.
Unlike the original product based on 1970's technology involving organic solvent based coating, Tris' product is based on its patented and highly versatile technology, LiquiXR®, which avoids the use of toxic organic solvents by employing an aqueous based coating system. Tris has pioneered the delivery of taste-neutral, extended release dosage forms such as liquids, ODT/chewable tablets, and film strips that are otherwise traditionally associated with immediate release.
Manufactured at Tris' U.S. Food and Drug Administration (FDA)-inspected, state-of-the-art facility in Monmouth Junction, NJ, Hydrocodone Polistirex & Chlorpheniramine Polistirex 10mg/8mg ER Suspension in 115ml and 473 ml bottles (compare to Tussionex®) are now available in the U.S. through wholesalers and distributors, as well as directly to the trade. Hydrocodone Polistirex & Chlorpheniramine Polistirex 10mg/8mg ER Suspension was approved by the FDA on October 1, 2010. It is distributed in accordance with FDA and U.S. Drug Enforcement Administration (DEA) regulations governing the handling of CII controlled substances.