Prescription OTC name Company and other details
Tagamet Tagament HB SmithKline Beecham, and launched in August 1977. 1993 sales at $528 million. Patent expired in May 1994.
Pepcid Pepcid AC JJM, and launched in November 1986. 1993 sales at $387 million. Patent expiry in 2000.
Zantac - Glaxo, and launched in June 1983. 1993 sales at $1,694 million. Patent expiry in late 1997.
Axid - Eli Lilly and American Home Products, and launched in May 1988. 1993 sales at $271 million. Patent expiry in 2000.
Timeline of the case:
August 1977 SmithKline launches Tagamet to treat ulcers, and later from 1989, SmithKline Beecham markets it
June 1983 Glaxo introduces Zantac
1985 SmithKline starts discussions with FDA on the OTC launch of Tagamet, named Tagamet HB
November 1986 Merck introduces Pepcid, and later from 1989, JJM markets it
May 1988 Eli Lilly introduces Axid, and later from 1989, Eli Lilly and American Home Products market it
March 1989 JJM was formed with Merck as the R&D part and J&J for the retail and distribution part.
April 1989 SmithKline Beckman, Tagamet’s marketer, merged with Beecham, a strong OTC marketer. The combined firm – SmithKline Beecham, the world’s second largest prescription and OTC drug company, had $12 billion in combined revenues with 60% from pharma products. Tums is the leading OTC antacid brand.
August 1989 Eli Lilly, a $7 billion pharma company, and American Home Products signed an agreement for American Home Products to develop and seek FDA approval for OTC formulations of selected Lilly prescriptions
October 1989 JJM acquired ICI America Inc., the US OTC business of a British firm, for $450 million. This gave access to $90 million-a-year Mylanta antacid and other products
1990-91 Number of clinical trials to prove the efficacy of both the claims of Pepcid AC
Late 1991 Provocative meal studies, where two groups were given Wendy’s chili with extra hot sauce and orange juice/ red wine to cause