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Registration date : 2008-11-09
 | | Subject: Reckitt faces loss of Suboxone drug patent Tue 04 Aug 2009, 7:32 pm | |
| Soon the orphan drug status for Suboxone will be up. It is going to be interesting to see who comes up with the generic version of this "miracle medication." October 8,2009. That is the date to keep your eye on.Reckitt faces loss of Suboxone drug patent
Reckitt Benckiser, the household goods company that stands to lose a major revenue driver when one of its leading drug patents expires in October, has launched moves to try and keep rival companies selling copycat products.
The FTSE 100 company has filed two Citizen Petitions in the US to push for changes that would see rivals forced to fulfil tough criteria before being allowed to sell Suboxone, a drug used to treat opiate addiction.
Orphan drug status for Suboxone is due to expire in the US on October 8 in a move that is likely to have a major impact on Reckitt's future revenues from its pharmacy division. The unit generates about 16pc of group profits.
Reckitt, which also owns drugs including Nurofen and Strepsils, has filed petitions with the US Food and Drug Administration in a bid to stave off the impact of the patent's expiry.
However, Andrew Wood, an analyst with Sanford Bernstein, the US investment bank, has warned the petitions are likely to be of limited success.
Mr Wood said it was likely that the FDA would take between three and six months to reach a conclusion on the petitions, adding that Suboxone was a relatively simple drug to assess and that the arguments in the petitions were "not particularly impressive".
"Even if the CPs [Citizen Petitions] are accepted, we consider that generic manufacturers are generally aware of such preconditions and tests, and some may already have met the conditions and conducted some if not all of the tests," Mr Wood said in a research note.
The likely effect of the patent expiry is likely to be at the centre of analysts' attention this week as Reckitt issues its interim results.
The company is expected to continue its recent run of extremely good form, with first half revenues forecast to be up 22pc at £3.75bn, leading to a 28pc increase in operating profits to £805m.
The group is expected to say that sales of its brands, which include Vanish and Cillit Bang, are continuing to grow despite competition from cheaper, own-label rival products.
The company is currently undergoing a rebranding that will see its name emerge as RB.
By Jonathan Sibun; 25 Jul 2009
Read article here.Posted by: Dee; August 4,2009 | |
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