Lemmon, Barre ANDAs for topical minoxidil clear FDA; Rogaine exclusivity denied.

OTC ROGAINE PRODUCTS DENIED THREE-YEAR WAXMAN/HATCH EXCLUSIVITY by FDA on April 5. As a result of the agency's ruling, Pharmacia & Upjohn's recently-switched minoxidil 2% hair regrowth treatment will enter the OTC market unprotected from competing private-label versions.

FDA approved OTC marketing of Rogaine for Men and Rogaine for Women on Feb. 9 ("The Tan Sheet" Feb. 12, p. 1). Pharmacia & Upjohn's patent for Rogaine expired Feb. 13 -- three days after the agency gave its nod to the switch application.

Following its determination not to grant exclusivity, FDA approved ANDAs for minodixil 2% submitted by Teva generic subsidiary Lemmon and Barre-National.

Bausch & Lomb, which gained tentative ANDA approval for private label minoxidil at the end of December, as did Lemmon ("The Tan Sheet" Jan. 1, p. 7), has not yet received final approval.

The ANDA approvals only cover OTC products for male pattern baldness. To gain approval for the women's indication, the generic firms must submit stability data on minoxidil 2% packaged in the applicator used by Pharmacia & Upjohn for its female alopecia product.

Although the OTC Rogaine products carry identical formulas and recommended doses, different applicators are included in the kits for men and women. According to the labeling, applicators "designed especially for men" include a child-resistant dropper and a sprayer that may be useful for "broader areas of hair loss." The women's product contains a spray applicator with an optional "extender" cap that can be used to spray through different hair styles.

In addition to providing information relevant to the different applicators, the labeling for the men's and women's products differ in that they reflect the varying hair loss patterns and supporting data unique to men and women.

Two television commercials for OTC Rogaine, one targeting women and the other men, are scheduled to air starting April 29, with consumer print ads to follow. Rogaine advertising is being handled by Grey Advertising of New York City. Rogaine shipments to food, drug and mass merchandisers began on April 3.

Pharmacia & Upjohn announced April 3 that a Rogaine pharmacy kit will be mailed to over 20,000 pharmacists in the next few weeks. The company noted that the kit will contain "an educational brochure and video for pharmacists, consumer education brochures and an announcement easel for the pharmacy counter." The firm also is planning a mailing to 40,000 physicians announcing Rogaine's OTC availability.

Other promotional efforts will include free-standing inserts, in-store circular ads, coupons and a direct marketing campaign. According to the company, customers who return reply cards inserted in the Rogaine packaging will receive periodic mailings, which will include coupons for both Rogaine and Progaine shampoo, advice from dermatologists and insight from other Rogaine users. A separate, yet "synergistic" advertising campaign for the shampoo will commence after the Rogaine ad launch.

FDA's decision to veto OTC Rogaine exclusivity is not unprecedented. The agency also denied exclusivity for Schering-Plough's Gyne-Lotrimin (clotrimazole) and Lotrimin AF and Sandoz' Tavist (clemastine).

A decision on Waxman/Hatch exclusivity for Smithkline Beecham's Nicorette is not expected until the end of April, according to FDA. The 2 mg and 4 mg smoking cessation gum, which also received FDA clearance for OTC marketing on Feb. 9, is slated to be launched in late April/early May. Nicorette's patent expired in August 1992 and exclusivity for the prescription version ran out in January 1994.