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Ramipril
Consequences to NHS of switch to tablet
From Mr A. Clarke
Ramipril is currently marketed by Aventis under the trade name Tritace.
It is licensed and sold in the United Kingdom as a capsule and in most
of the rest of Europe it is presented as a tablet. A number of British
manufacturers have independently developed a capsule presentation for
the UK market, and subject to gaining the necessary marketing authorisation
approvals, will be aiming to launch these products from 9 January 2004,
when the patent for Tritace expires.
As Dr Martin Ford, medical director, Aventis, indicates (PJ, 25 October,
p578), Aventis anticipated a considerable drop in Tritace sales following
patent expiry and this played a part in the decision to change to tablets.
This switch by Aventis raises a crucially important issue for the generics
industry. Dr Ford’s comments clearly indicate that the move is
simply a way to extend the monopoly period Aventis enjoys for Tritace
and hinder generic competition. We also believe that it may result in
adverse consequences for the NHS drugs budget.
Current UK sales for ramipril are just under £125m per year. We
believe that significant savings would be undermined if there is only
a single manufacturing source and supplier for ramipril used by the NHS.
It would take generics manufacturers potentially up to two years to undertake
independent development work and gain the necessary regulatory approval
for the tablet form.
If the Aventis switching strategy, which includes changes via general
practitioner software suppliers, is successful and prescriptions are
mostly generated for tablets, then there will be little or no market
for generic ramipril capsules. This does not tally with the comment from
Dr Ford that there will be strong price competition from the beginning
of 2004.
Finally, ramipril is used
to treat a range of chronic cardiac conditions. Experience has shown
that altering the appearance of medicines raises concerns with patients
and inevitably causes some problems with patient compliance. Where ramipril
is concerned we fear that this will occur as a result of Aventis’s
action, without any good reason or cost saving to the NHS.
Andy Clarke
Sales and Marketing Director,
Sandoz
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