The US FDA has granted approval for a new dosage strength (16mg/4mg) of the buprenorphine and naloxone sub-lingual film to Teva under the 505 (b) (2) pathway. In our view, this could further lower the Suboxone opportunity by the time Dr Reddy’s (DRRD) re-enters the market. To recall, as per the preliminary injunction (PI) granted by US District Co-urt of New Jersey to Indivior in Jul-18, DRRD cannot sell Suboxone until the patent litigation related to the ‘305 patent is concluded or until DRRD receives a fa-vourable verdict in the US Court of Appeals.
The US FDA has approved Teva’s Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. In the case of Cassipa, Teva submitted a 505 (b) (2) application that relied, in part, on the FDA’s finding on the safety and effe-ctiveness for Suboxone sublingual film to support approval. Indivor and Teva had agreed that the latter’s 16mg/4mg dosage strength would be governed by the verdict of the infringement ruling for DRRD’s 8mg/2mg dosage strength. In Aug-17, there was a non-infringement ruling in favour of DRRD for patents ‘150, ‘514 and ‘497, which meant that even Teva’s 16mg/4mg dosage strength was found not to infringe.
Teva has received approval for a higher dosage strength (16mg/4mg) of Suboxone under the 505(b)(2) pathway. DRRD and Mylan are the only generic companies to receive an approval for Suboxone, albeit for lower strengths. While DRRD has received final ANDA approval for the 2mg/0.5mg, 4mg/1mg, 8mg/2mg and 12mg/3mg variants, Mylan has received approval for the 8mg/2mg and 12mg/3mg variants. We await clarity on the dosage requirements of the 16mg/4mg strength.