Amneal/Mallinckrodt Enter Buprenorphine+Naloxone Distribution Agreement
Mallinckrodt has entered into an agreement with Amneal Pharmaceuticals to distribute to addiction treatment centres Mallinckrodt's buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets (CIII), a generic version of Reckitt Benckiser's Suboxone. The product is manufactured in Amneal's Hauppauge, NY, facility. It is a prescription medication indicated for the maintenance treatment of opioid dependence. The contract covers a period of three years, with an option to extend.
Mallinckrodt commented that it was a major supplier of generic opioid dependence products to US addiction treatment centres. The collaboration is the first between Mallinckrodt and Amneal and covers both the 8mg/2mg and 2mg/0.5mg dosage strengths of buprenorphine+naloxone. Mallinckrodt's version was approved by the FDA on February 22 2013; to date only two generic versions have been approved, with the other belonging to Actavis. This was approved on the same day as Mallinckrodt's.