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Novartis hit by generic competition for Diovan in the UK as the drug's EU patents fall

Actavis launches generic valsartan on the first day patent protection expired across a number of EU member states

Actavis launched generic versions of various formulations of Novartis' blood pressure drug Diovan in the UK yesterday, on the first day that patent protection expired across a number of EU member states.

Diovan (valsartan) remains Novartis' biggest product with sales of $4.48bn in the first nine months of the year, though this was down 3 per cent as generics started to eat into revenues in some world markets, notably Brazil, Canada and Spain.

Supplementary protection certificates (SPCs) for Diovan in a number of European markets were due to expire in May this year, although in a number of EU countries Novartis was awarded six-month paediatric SPC extensions, extending protection to this month.

The UK is among a number of other EU countries now clear for the launch of generics, so erosion of Diovan's sales is expected to gain pace, albeit offset by growth in Japan and some emerging markets, such as China, where it remains under patent. The big hit is expected to come in 2012, however, when patents are lost in the US and a raft of other countries.

Novartis has been trying to bolster the Diovan franchise with the launch of new line extensions, notably Co-Diovan (valsartan and hydrochlorothiazide) - itself facing patent expirations in a number of markets - and Exforge (valsartan and amlodipine). The latter is injecting some renewed vigour in the portfolio with sales up by 36 per cent to $317m in the last quarter.

Meanwhile, Novartis has also been trying to shift the emphasis to Rasilez (aliskiren), its renin inhibitor-based antihypertensive which grew 47 per cent to $305m in the first three quarters of 2011. A triple combination pill based on aliskiren, amlodipine and hydrochlorothiazide - called Rasitrio - was recently backed for approval in the EU.

Actavis said it launched seven valsartan stock-keeping units (SKUs) in the UK, including tablets, capsules and valsartan/hydrochlorothiazide film-coated tablets.

Michael Cann, generics director at the company, said: ""In 2011 Actavis has brought 13 products to the generics market on day one of patent expiry and we will continue to demonstrate our dedication to extending our existing portfolio of over 500 generic medicines."

15th November 2011

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