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US
evaluates generic cipro from India
Our
Corporate Bureau
Mumbai, Oct 17: America's growing demand for ciprofloxacin
— one of the antibiotics used to treat anthrax — and its inability
to source the drug at the most competitive rates is threatening
to bring to the fore a host of patent-related issues. The
current situation, experts say, may also lend greater credence
to the cries of the developing world against a “one-size-fits-all”
patent system.
| Doxycycline
to combat anthrax |
Ciprofloxacin is not the only antibiotic
that can be used to treat anthrax. Doxycycline and penicillin
are also said to be effective, though experts caution
that these drugs may be less potent against the resistant
strains.
Key players in the doxycycline market include USV, Jagson
Pal, Lyka, Biochem etc, though Ranbaxy’s spokesperson
said that the company can make supplies of this drug too.
It is unclear how many of the smaller players have the
requisite approvals for making international supplies.
Alembic, Franco-Indian and Sarabhai are those with penicillin-based
drugs in the market. |
German giant Bayer’s US patents
on ciprofloxacin expires on December 9, 2003 and except for
sourcing the bulk active of the drug for R&D purposes
(permissible under the Bolar provisions) US generic companies
can do little but watch Bayer fill its coffers. The US can,
however, opt for the compulsory licensing route and there
now seems to be hope for consumers and US/Indian generic drug
companies.
Senator Charles E Schumer, Democrat of New York, has now proposed
that the US government buys generic versions of ciprofloxacin
for its emergency stockpile, according to reports in The New
York Times. Senator Schumer says that such as step would reduce
dependence on a Continued on Page 3US evaluates generic cipro
from India single supplier and could significantly reduce
costs.
In fact, Mr Schumer is reported to have held talks with three
generic manufacturers including Ranbaxy Laboratories. Ranbaxy’s
official spokesperson said that the company has offered to
supply 10-20 million cirpofloxacin tablets by mid-December
and added that prices will certainly be “very attractive”.
US sales of cipro last year were worth $1 billion and Bayer’s
average wholesale price is $4.67 per 500 milligram. Corresponding
generic versions in India would cost between Rs 8 and Rs 10
per tablet, analysts said. Ciprofloxacin (bulk) prices have
also inched up to $30 per kg from $25 some time ago.
Another potential supplier is the Mumbai-based Cipla and joint
managing director Amar Lulla said that the company can easily
match Ranbaxy’s supplies. The company already has a Drug Master
File (DMF) (a pre-requisite for making supplies of bulk actives
internationally) for bulk ciprofloxacin and chairman and managing
director Dr YK Hamied says that a US generic company has been
buying the bulk from it since February 2000. The US firm has
already filed an abbreviated new drug application (ANDA) and
will enjoy six-months marketing exclusivity once the drug
goes off patent.
Says Dr Hamied, “This is a test case and there are lessons
that India must learn from this. We must not give in to Trips.
Patents are national laws,” he stressed. Dr Hamied added that
the US should issue compulsory licences to generic firms to
tide over the crisis.
Director of the Consumer Project on Technology, James Love,
has been quoted in The New York Times as saying that any employee
of the US government can authorise a compulsory licence for
the product without even holding a hearing, though experts
say that the implications of such a move will be far-reaching.
Meanwhile, Bayer plans to reopen a German facility to increase
cipro output by 25 per cent and is also expanding manufacturing
at its Connecticut unit to 24 hours.
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