Generic Version of Amrix® (cyclobenzaprine extended-release) Now Available

Medicare Set-Aside Blog on August 25, 2011 | Posted by

A generic version of Amrix® (cyclobenzaprine extended-release) was released by Mylan pharmaceuticals on 05/13/2011. As the first manufacturer to bring a generic formulation to market, the FDA granted to Mylan a 180 day period of marketing exclusivity for cyclobenzaprine extended-release 15mg and 30mg capsules. The 180 day period of exclusivity begins on the date of release; in this case, it began on 05/13/11. During the 180 day period of exclusivity, the AWP for the generic product is often the same as, or only slightly less than, the AWP for its brand name counterpart. This is currently true for Amrix® and the generic cyclobenzaprine extended-release formulations.

When the 180 day exclusivity period is over, other generic manufacturers will likely begin to market cyclobenzaprine extended-release formulations and we will hopefully see a drop in AWP at that time.  Until then, the AWP established by Mylan for its generic cyclobenzaprine extended-release formulations will be the only AWP available for a generic version of Amrix®.