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UPJOHN OTC IBUPROFEN (HALTRAN) WILL HAVE TWO-MONTH ADVANTAGE

Executive Summary

UPJOHN OTC IBUPROFEN (HALTRAN) WILL HAVE TWO-MONTH ADVANTAGE over the next wave of OTC ibuprofen introductions. Upjohn plans to introduce its product in July; other versions of OTC ibuprofen will not be able to enter the U.S. market until Sept. 24, when exclusivity provisions protecting Upjohn and American Home Products NDAs will expire. At least five manufacturers are waiting in the wings for the exclusive marketing period to expire, including McNeil, which intends to market ibuprofen OTC under the tradename Medipren. The other four firms already cleared to market OTC ibuprofen in September are Par, Barr, Danbury and Chelsea. At the time of the initial approval of 200 mg. ibuprofen for the OTC market in 1984, Upjohn opted out of a marketing battle in the OTC analgesic class and sublicensed the product to Bristol-Myers. Upjohn is positioning Haltran in the menstrual pain market. The company's supplemental approval is exclusively for the dysmennorhea indication. The initial OTC ibuprofen products contain reference to menstrual pain among other minor pain indications. Initial announcements to the trade for Haltran emphasize Upjohn's experience with Rx ibuprofen and the dysmennorhea indication. For example, an ad in the June 9 issue of Drug Store News states: "The Upjohn Company, first in ibuprofen therapy with the introduction of Motrin, now announces new Haltran: the first OTC ibuprofen positioned specifically for the relief of menstrual pain. New Haltran ships in July. See your Upjohn representative for details." The decision to venture into a subcategory of the OTC analgesic field with ibuprofen apparently represents a corporate decision by Upjohn to expand its activity in the OTC business. In a June 3 speech by Upjohn Vice Chairman Theodore Cooper, the company declared the renewed interest in OTCs: "We have decided to establish Consumer Products as a self-standing division of the company, and we expect important contributions from this new division." The compoany is reacting to switch decisions in two of its major product lines in recent year: nonsteroidal anti-inflammatories and topical steroids UPJOHN ELEVATES OTC BUSINESS: MORE Rx-TO-OTC SWITCHES ANTICIPATED Excerpted from a June 3 speech by Upjohn Vice Chairman Theodore Cooper. Recently we have noted a trend toward increased self-treatment on the part of consumers and a greater willingness on the part of the FDA to approve the switching of certain prescription products to over-the-counter status. As a result, we have reevaluated the role of our Consumer Products Unit. We have decided to establish Consumer Products as a self-standing division of the company, and we expect important contributions from this new division. According to studies released by SRI, by the year 2000 the over-the-counter market will be as large as the prescription market; projections indicate that, in the United States, each market will be about $50 bil. It is our feeling that companies such as Upjohn, with a number of prescription products that can be "carried over" to OTC status, will be in a unique position to profit from this area in future years.
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