November 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.

According 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."

Pharmacia's 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.

Typically 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 hair growth.