ROGAINE, NICORETTE SEEK EDGE FROM FDA

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Rogaine and Nicorette, separately approved last week to cross over-the-counter, now face the hurdle of winning market exclusivity for several years of unfettered sales.

Pharmacia & Upjohn's Rogaine will reach stores in April, propelled by a $35 million-plus network TV and cable campaign via Grey Advertising, New York.

SmithKline Beecham's Nicorette nicotine gum also hits stores that month, with a $30 million to $35 million OTC campaign from Jordan, McGrath, Case & Taylor.

Rogaine, which will retail at $30 a month, received $38.7 million in direct-to-consumer ad support through November 1995; Nicorette, at $45 to $55 for a starter kit, got slightly more than $1 million.

Both products seek approval of three-year marketing protection from the Food & Drug Administration under the Waxman-Hatch Act. A decision isn't expected before late March or April.

POTENTIAL ROGAINE RIVALS

Rogaine lost patent protection effective Feb. 13; Bausch & Lomb and Lemmon Co., a division of Israeli-based Teva Pharmaceutical Industries, have sought generic competition and have tentative approvals from FDA.

"We do see a market for [the hair restoring ingredient] minoxidil as viable and would very much like to be a player," said a Bausch & Lomb spokeswoman.

Nicorette lost its prescription marketing exclusivity in January 1994 and hasn't had direct competition in the $264 million market, except for nicotine patches.

The brand saw sales increase 5.6% to $65 million in 1995, and is making the leap to OTC well before its patch competition.

A petition filed on behalf of an unnamed manufacturer challenges the additional protection for Nicorette. A possible contender is Ciba-Geigy Corp., marketer of Nicotinell gum in the U.K.

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