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ACTIFED, DIMETANE, AND DRIXORAL FORMULATIONS LOSE OTC EXCLUSIVITY AS TWO YEAR WAXMAN/HATCH TRANSITION PERIOD RUNS OUT; OTC IBUPROFEN MARKET BECOMES A CROWD

Executive Summary

Actifed, Dimetane, and Drixoral OTC dosage forms and strengths join 200 mg ibuprofen as Rx-to-OTC switch products now available for marketing through an ANDA, following expiration of the Waxman/Hatch two year exclusivity period on Sept. 24. According to FDA's Approved Prescription Drug Products with Therapeutic Equivalence Evaluations, OTC exclusivity for pseudoephedrine/triprolidine (Burroughs Wellcome's Actifed), controlled release brompheniramine maleate 8 mg and 12 mg (Robins' Dimetane) and controlled release dexbrompheniramine 6 mg/pseudoephedrine 120 mg (Schering's Drixoral) ran out on Sept. 24. All three products had taken the NDA route in switching from Rx to OTC and had received approval during the Jan. 1, 1982 to Sept. 24, 1984 transition "window" provided in the ANDA/patent restoration bill signed into law two years ago. The wave of new OTC ibuprofen products coming on to the market has received the most attention in the business and lay press. McNeil's Medipren, Thompson Medical's Ibuprin and a number of private label ibuprofen products are expected to move in on American Home Product's Advil and Bristol-Myers' Nuprin. Reportedly, Sterling is also planning to enter the OTC ibuprofen market. To date, FDA has approved ANDAs from seven companies for ibuprofen 200 mg, including Par, Barr, Chelsea, Dambury, Cord, Ohm, and McNeil, which has ANDA approvals for two tablet forms of ibuprofen. Most recently, Barr received a second ANDA approval for 200 mg ibuprofen in brown tablets on Sept. 26. VLI's monopoly position in the OTC contraceptive sponge area could be threatened by the loss of the Today sponge's exclusive use of the spermicide nonoxynol-9 in a vaginal sponge. VLI has petitioned FDA to require full NDAs with clinical data and sponge stability and safety results for marketing approval of additional nonoxynol-9 contraceptive sponges ("The Pink Sheet" July 28, T&G 1). Chart omitted.

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