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Prandin |
|
S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl)
phenyl)-butyl)
amino)-2-oxoethyl) benzoic
acid |
|
Empirical formula |
C27H36N2O4 |
|
Molecular weight |
452.6 |
|
Bioavailability (Oral) |
56% |
|
Metabolism |
oxidative biotransformation
and direct conjugation with
glucuronic acid |
|
Elimination half life
(Oral) |
1 hour |
|
Excretion |
in the
faeces |
Prandin is a branded drug for
the treatment of
type II diabetes. The drug's
generic name is repaglinide and it
is supplied by
Novo Nordisk.
Prandin belongs to the
meglitinide class of blood
glucose-lowering drugs.
Pharmacology
Prandin lowers blood glucose by
stimulating the release of
insulin from the
pancreas. It achieves this by
closing
ATP-dependent
potassium channels in the
membrane of the
beta cells. This depolarizes
the beta cells, opening the cells'
calcium channels, and the
resulting calcium influx induces
insulin secretion.
Dosage
Prandin is delivered in tablet
form.
History
Precursor drugs to repaglinide
were invented in late 1983 by
scientists at Dr Karl Thomae GmbH,
a German drug manufacturer located
at
Biberach an der Riß in
southern Germany which was
acquired by
Boehringer Ingelheim in 1990.
The drug that became repaglinide
was later licensed by Boehringer
to Novo Nordisk, which filed an
Investigational New Drug
application for the compound with
the
FDA in April 1992. Novo
Nordisk filed its
New Drug Application (NDA) for
Prandin in July 1997 and it was
quickly approved, gaining FDA
approval in December 1997. The
drug was the first of the
meglitinide class. It was branded
Prandin because its quick
onset and short duration of action
concentrates its effect around
meal time (the prandium was
the Roman meal which is comparable
to the modern lunch).
Intellectual property
After several attempts to file
for U.S.
patent protection, a filing
was made in March 1990 which
eventually became U.S. Patents
5,216,167 (June 1993), 5,312,924
(May 1994) and 6,143,769 (November
2000). After filing its NDA for
repaglinide in 1997, Novo Nordisk
applied for patent extension under
the
Hatch-Waxman Act. This
process, called patent term
restoration, allows drug
patents to be extended based on
the time that a drug spent in
clinical trials and in the
approval process. Previously it
had been decided by the
U.S. Patent and Trademark Office
that the expiration date of U.S.
Patents 5,216,167 and 5,312,924
would be
5 September
2006. In February 2001
Prandin's patent life was extended
to
14 March
2009 in response to Novo
Nordisk's patent term restoration
application, with U.S. Patent
5,216,167 having been reissued as
RE37035.
Generic status
As per the above paragraph,
Prandin will not become available
as a
generic drug in the United
States before March 2009.
Supply
Prandin is available in 0.5 mg,
1 mg and 2 mg tablets.
