Generic Beyaz
February 13, 2012
WATSON Pharmaceuticals has
filed an application with the US FDA
to market drospirenone and
ethinyl estradiol and levomefolate
calcium tablets, 3.0mg/0.02mg/
0.451mg and levomefolate calcium
tablets, 0.451mg (a generic version
of Bayer’s Beyaz).
Beyaz is an oral contraceptive
indicated for use by women to
prevent pregnancy, treat
symptoms of premenstrual
dysphoric disorder for women who
choose to use an oral contraceptive
for contraception, treat moderate
acne for women at least 14 years
old only if the patient desires an
oral contraceptive for birth control,
and to raise folate levels in women
who choose to use an oral
contraceptive for contraception.
The request for approval follows
a suit filed in February by Bayer
against Watson, which seeks to
prevent the latter from
commercialising the generic Beyaz
prior to the expiration of Bayer’s
Beyaz patent.
The lawsuit was filed under the
provisions of the Hatch-Waxman
Act, resulting in a stay of final FDA
approval of Watson’s generic for
up to 30 months from the date the
plaintiffs received notice of
Watson’s filing or until final
resolution of the matter before the
court, whichever occurs sooner.
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