23, 2000 - Pharmacia, maker of Rogaine Extra Strength
for Men, has temporarily put the brakes on the release
of an OTC generic 5% Rogaine by filing a last minute
application to the FDA to have their patent extended. Pharmacia's
petition is based on them testing Rogaine for use in children.
to a statement released by a representative of Alpharma, one
of the companies approved to sell the generic 5% by the FDA,
"There will be a delay in the launch of the generic version
of Rogaine Extra Strength 5% due to the brand's manufacturer
having filed for patent protection for an additional six months
claiming pediatric exclusivity."
patent was to expire on November 14th, 2000 and several companies
were given conditional approval by the FDA to begin selling
a generic 5% Rogaine equivalent. Alpharma, Copley Pharmaceutical
and L. Perrigo Company were preparing for the release of their
products when they were given word by the FDA that they would
have to wait until it has reviewed Pharmacia's application.
it can take the FDA up to 60 days to review the petition,
but a decision can be issued a lot sooner. If the FDA did
take 60 days to review the application and did approve it,
the generic 5% Rogaine would not be available until
at least August of 2001. If the FDA reviewed it promptly and
rejected the application, stocks could be on the shelves within
weeks as companies like Alpharma have already produced supplies
of the generic Rogaine.
Generic 2% Rogaine has already been approved and has
been on the market since April 1996. Rogaine is the
only FDA approved topical solution currently available for