Fluvastatin Sustained Release 80 mg tablets: Actavis launched generic version in UK, Holland after favorable patent litigation outcome

Generic player Actavis has launched Fluvastatin SR in the UK and the Netherlands (as reported by Actavis in press release Here). Actavis was first to market in both countries.

Fluvastatin SR extended release tablets from Actavis are the generic equivalent of Novartis‘ Luvinsta® SR / Lescol® XL and are available in 80mg tablets in both markets. Fluvastatin SR is used to treat high cholesterol levels in the blood.

Fluvastatin SR tablets are manufactured by Actavis Malta and developed by Actavis‘ R&D in Iceland.

This launch was possible after Actavis won a court case in January 2009 in the UK, whereby Novartis’ following formulation patent was revoked:

EP0948320 (Assignee: Novartis): Following independent claims were litigated in the trial

Claim1 which covers a pharmaceutical composition for sustained release, said composition comprising a water soluble salt of fluvastatin as active ingredient and being selected from the group comprising matrix formulations, diffusion-controlled membrane coated formulations; and combinations thereof.

Claim2 which covers use of a water soluble salt of fluvastatin for the manufacture of a pharmaceutical composition for sustained release, for the treatment of hypercholesterolemia.

The said patent was revoked (otherwise, the patent would have prevented the launch of the product until 2017) on obviousness grounds, in the light of following prior art:

(1) British National Formulary (March 1996 )
(2) US4739073
(3) WO199506470

The formulation patent has also been revoked in the Netherlands.

Fluvastatin was the first fully synthetic HMG-CO-A analogue; The compound was patented as product patent EP114720 in the the early 1980s (now, expired). A Supplementary Protection Certificate (SPC) in respect of the patent covering Fluvastatin (EP114720) expired on 22 August 2008.

The compound received marketing approval for use in humans at the end of 1993 and was first marketed in 1994. At the priority date of EP0948320 (which, 8 October 1996), the drug was available in the form of capsules containing 20 mg or 40 mg of Fluvastatin sodium (a water-soluble salt of the active ingredient).

Link to court decision Here