British Reckitt Benckiser Pharmaceuticals (RB Pharmaceuticals) makes the originator Suboxone, which treats opiate addiction by preventing symptoms of withdrawal from heroin and other opiates. Suboxone lost its US patent protection in 2009, but RB Pharmaceuticals had filed a Citizen’s Petition with FDA to try and stop the agency approving any generics unless they adopt stringent packaging standards.

In its petition RB Pharmaceuticals presented a new evaluation of paediatric exposure data and recommended that FDA adopt more stringent packaging standards and increased educational interventions to help reduce the number of children exposed to buprenorphine-containing products used to treat opioid dependence. FDA concluded, however, that the safety data presented by RB Pharmaceuticals did not warrant these additional measures, deciding instead that existing labelling and safety programmes were sufficient.

The generic buprenorphine/naloxone versions have been approved from US-based generics manufacturers Actavis, formerly Watson, and Amneal Pharmaceuticals, in 2 mg/0.5 mg and 8 mg/2 mg dosage forms.

RB Pharmaceuticals said in its press release that the company was ‘disappointed with the decision’ but would ‘continue to work with FDA on safety enhancements’. Amneal Pharmaceuticals, on the other hand, applauded FDA’s decision, saying that the decision was in favour of generics competition and would ‘ensure that millions of patients in the US who need this product now have access to a high quality, low cost generic version’. The generics company was also pleased that FDA had referred the case to the Federal Trade Commission ‘to investigate and address Reckitt’s anticompetitive business practices’.

For 2012, Suboxone tablets had total US sales of approximately US$625 million, for these dosage forms and approximately US$1.5 billion for all dosage forms, according to IMS Health data.

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