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[e-drug] Clavulanic acid (ir)ratios (3)

  • Subject: [e-drug] Clavulanic acid (ir)ratios (3)
  • From: [email protected]
  • Date: Sun, 29 Sep 2002 09:57:48 -0400 (EDT)

E-DRUG: Clavulanic acid (ir)ratios (3)
[We discussed the confusing array of fixed dose combinations of amoxicillin
and clavulanic acid recently. One E-drugger sent me a copy of an May 2002
message in IP-Health, which reported that the Augmentin patents by GSK had
been invalidated.
This meant that the way was free for generics of co-amoxiclav.

The clavulanic acid patents from1974 and 1979 have also expired.

As the next strategy, GSK tried to use a "trade secret" court case to keep
generics from the profitable market (E-drug carried that one on 23 August).
We haven't heard that outcome yet - anybody?

Anyway, generic combinations of amoxicillin and clavulanic acid should
become widely available now, as the premium paid for adding clavulanic acid
is substantial: a plain amoxicillin 500mg capsule costs only USD 0.032, but
current generic price of amoxicillin 500mg + 125mg clavulanic acid USD
0.2715 [Median price, Intl Price Indicator 2001]. This is a premium of USD
0.24 per capsule. Surely, someone could make clavulanic acid cheaper?

Message below from IP-HEALTH with thanks. Copied as fair use. WB]

Dr Wilbert Bannenberg, E-drug moderator
Box 456, Irene 0062, South Africa
Mobile +27-82-5756249
Tel +27-12-6671752
Fax +27-12-6671762
Email: [email protected]

Judge tosses out Glaxo patents for antibiotic Allows rivals' low-cost
versions By Bloomberg News, 5/24/2002

NORFOLK, Va. - A federal judge invalidated GlaxoSmithKline PLC's patents
Augmentin, clearing the way for rivals to introduce low-cost versions of
$2 billion-a-year antibiotic.

Glaxo's US shares fell 3.3 percent, their biggest one-day drop since July
23. Generic-drug makers Teva Pharmaceuticals Industries Ltd., Novartis AG's
Geneva Pharmaceuticals Inc. unit, and Ranbaxy Laboratories Ltd. sued to
invalidate three patents that protect Augmentin from generic competition
through December.

US District Judge Henry Morgan said the patents don't contain new
and should be invalidated. His decision will cost Glaxo its exclusive right
to sell the antibiotic, which brings the company $3 million a day in US
sales. Augmentin is a compound that works like  ''defensive lineman'' to
destroy penicillin-resistant bacteria, the judge said.

''We are disappointed and do expect to appeal,'' said Glaxo spokeswoman
Patricia Seif. ''If we prevail on appeal, we will seek to recover any lost

The Middlesex, England-based company's American depositary receipts, each
worth two ordinary shares, fell $1.56 to $46.39 yesterday in trading of 1.6
million shares, almost twice the three-month daily average.

Teva's American depositary receipts, each representing one ordinary share,
rose 98 cents to $67.03. Novartis ADRs, each representing one ordinary
share, rose 17 cents to $43.38.

Geneva, based in Plainsboro, N.J., is the only one of the three Glaxo
with US Food and Drug Administration approval for a generic form of the
drug. [PARA]The question for Geneva, said Rafael Tamargo, director of
research at Wilmington Trust Co., is: ''Do the generics want to take the
chance and bring it to market?''Wilmington Trust owned 389,773 Novartis
shares in March, according to Bloomberg data. He said the generic-drug
companies are likely to take that risk.

''I think the courts are taking generally a more cynical view of the patent
industry,'' Tamargo added. ''I think the benefit of the doubt will go
the generics at this point.''

Geneva spokeswoman Sandra MacTavish said the company doesn't have a set
to begin selling generic forms of Augmentin. ''We have not made a decision
yet about when we will launch our generic version of Augmentin, but we are
eager to get our product into patients' hands as soon as possible,'' she

Teva, based in Israel with US headquarters in North Wales, Pa., and
based in India with US headquarters in Princeton, N.J., have filed
applications with the FDA. ''We are quite pleased with the court's careful
consideration of the evidence,'' said Teva lawyer Thomas Meloro.

Glaxo said yesterday that its earnings per share growth would be cut to 10
percent from the mid-teens in 2002 and to the ''high single digits'' from
the low-teens in 2003 if a generic rival to Augmentin hits the market as
early as July. The company also said it expects to file at least 13
new products between 2003 and 2005.

Augmentin, with $1.3 billion in US sales last year and $2 billion
accounts for about 7 percent of Glaxo's $29 billion in annual sales. It's
Glaxo's second-biggest product behind the antidepressant Paxil.
[PARA]Generic drugs are chemically identical to branded medicines and
usually can only be sold after patent protection for the brand expires.
Because their makers spend less on research and marketing, generics usually
sell for less than half the price of brand-name equivalents. [PARA]This
story ran on page C3 of the Boston Globe on 5/24/2002. [NL](c) Copyright
2002 Globe Newspaper Company.

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