EC accuses J&J and Novartis of delaying generic fentanyl

Home/Pharma News | Posted 15/02/2013 post-comment0 Post your comment

On 31 January 2013 the European Commission (EC) sent a statement of objections, to US-based Johnson & Johnson (J&J) and Switzerland-based Novartis accusing them of delayed entry of a generic painkiller.


The companies’ Dutch subsidiaries allegedly reached an agreement to delay, for money, the entry of cheaper generic versions of fentanyl pain killer patches onto the market in The Netherlands.

The EC had opened antitrust proceedings against the two companies back in October 2012 to investigate ‘pay-for-delay’ practices between the two parties, stating that ‘paying a competitor to stay out of the market is a restriction of competition that the Commission will not tolerate.’

The preliminary investigation by the EC found that Janssen-Cilag, the J&J subsidiary supplying the pain-killer fentanyl in The Netherlands, concluded a so-called ‘co-promotion agreement’ with its close generics competitor Sandoz, a Novartis subsidiary, in July 2005. At the time there were no regulatory barriers to develop and market generic versions of the fentanyl patches and therefore for Sandoz to enter the Dutch market.

The agreement between the two companies allegedly involved Sandoz receiving monthly payments from Janssen-Cilag for as long as no generic drug product was launched in the Dutch market. According to the EC this resulted in Sandoz abstaining from entering the Dutch market with generic fentanyl patches for the duration of the agreement from July 2005 until December 2006. The EC therefore concludes that ‘this may have delayed the entry of a cheaper generic medicine for seventeen months and kept prices for fentanyl in The Netherlands artificially high’.

Fentanyl, which was developed as a potent anaesthesia drug in the 1960s by J&J subsidiary Janssen Pharmaceuticals, is the generic name of J&J’s former blockbuster pain patch Duragesic. The patch, which lost patent protection in 2005, is a strong pain killer (stronger than morphine) used to relieve chronic pain, e.g. in cancer sufferers.

Both companies will have the chance to formally respond to the accusation.

Sandoz said in a statement that both ‘Sandoz and Novartis operate to the highest of standards and take the position of the Commission seriously. They will closely examine the Statement of Objections and will avail themselves of their rights of defence as provided for in the process.’

While spokesman for Janssen-Cilag, Mr Stefan Gijssels, said ‘Janssen continues to believe that these arrangements were legitimate’. Adding that ‘Janssen supports a sustainable healthcare system, where patients have access to both innovative and generic drugs’.

Agreements to delay the introduction of generic drugs or ‘pay-for-delay’ agreements have come under increasing scrutiny in both Europe and the US in recent years, with EC and Federal Trade Commission concluding that such deals are anticompetitive and lead to both patients and governments paying more for medicines.

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Source: EC, Europa, Sandoz

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