Generic Suboxone® Launches
On March 5, 2013, Amneal Pharmaceuticals LLC announced that its generic equivalent of Suboxone®, Buprenorphine HCl and Naloxone HCl Dihydrate Tablets, 2mg/0.5mg and 8mg/2mg, may be shipped to pharmacies for dispensing and sale to the consumer/patient.
Buprenorphine HCl and Naloxone HCl is the new-to-market generic equivalent of Reckitt Benckiser’s brand product, Suboxone® tablets, and had annual U.S. sales of $1.5B across the product family, according to December 2012 IMS Health market data.
Suboxone® is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. This product was approved under a Risk Evaluation and Mitigation Strategy (REMS) program.