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Tylenol Arthritis Extended Relief Caplets

This article was originally published in The Tan Sheet

Executive Summary

McNeil relaunching Tylenol Extended Relief under new name; the renamed acetaminophen product, slated to ship before August, was promoted to the trade at the NACDS Marketplace show in Philadelphia June 28-July 1. Original Tylenol Extended Relief, marketed under an approved NDA, was introduced in 1994. The analgesic contains 650 mg acetaminophen and employs a bi-layer system for the eight-hour time-release mechanism. Indications on a label mock-up read: "For the temporary relief of the minor pain of arthritis, and the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the pain of menstrual cramps and for the reduction of fever." The product is not covered by Waxman/Hatch exclusivity; several patents covering "oral sustained release acetaminophen formulation and process" expire in 2007. Tylenol Extended Relief is sold in three SKUs: a 24-count retails for about $3.70, a 50-count for $5.70 and a 100-tablet bottle for about $8.40. The repositioning appears to follow a growing trend toward indication specific OTCs; Bristol-Myers Squibb recently introduced Excedrin Migraine for relief of mild to moderate pain associated with migraine headache ("The Tan Sheet" Jan. 19, pp. 1-5)...

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Perrigo

Private label manufacturer preparing to launch extended-release acetaminophen in anticipation FDA will approve its ANDA by year end. Promotional material at the PLMA annual trade show in Chicago compares the 650 mg pain reliever/fever reducer "to the active ingredient in Tylenol Arthritis." In July 1998, McNeil relaunched Tylenol Extended Relief under the name Tylenol Arthritis Extended Relief Caplets (1"The Tan Sheet" July 6, 1998, p. 18). Allegan, Mich.-based Perrigo also expects agency approval of its ANDA for 5% minoxidil topical solution "well before" Pharmacia & Upjohn's three-year marketing exclusivity expires Nov. 14, 2000. Alpharma's ANDA for private label Rogaine Extra Strength for Men was tentatively approved July 22 (2"The Tan Sheet" Aug. 2, In Brief)

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Perrigo promotes in pricing, planning

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