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Executive Summary

LEMMON WILL MARKET FIRST CARDIZEM SR GENERIC VERSION in the U.S. following FDA's Nov. 30 approval of an ANDA for extended- release diltiazem 60, 90 and 120 mg capsules. The ANDA is held by a French drug delivery company, Prographarm, which developed the product in collaboration with Lemmon and its Israeli parent Teva. Lemmon said it plans to launch the twice-a-day diltiazem formulation "shortly." Cardizem SR sales through the first nine months of 1993 were $97 mil. in the U.S., down 43%, Marion Merrell Dow said. MMD has been shifting patients from the twice-daily product to once-a-day Cardizem CD. MMD has not attempted to preempt the generic market for the twice-daily dosage by introducing a version through its Blue Ridge Labs subsidiary, a strategy it employed when immediate- release diltiazem faced generic competition in late 1992. Teva describes Prographarm as "a privately owned, medium-sized French company specializing in coating technologies and the development and manufacture of sophisticated drug delivery formulations." In 1991, the French firm, located in Chateauneuf en Thymerais, had sales of $6 mil. and 53 employees. Prographarm will manufacture the diltiazem extended-release capsules for Lemmon in France. Another "first generic" approval in late November was Bausch & Lomb's tobramycin ophthalmic solution .3%, equivalent to Alcon's Tobrex. Bausch & Lomb plans to start distributing this month from its Tampa, Florida manufacturing facility. For the month of November, FDA approved a total of 10 ANDA/AADAs. In addition, Novopharm received a tentative ANDA approval for naproxen sodium. Duramed will begin marketing a generic estropipate supplied by Ortho during the week of Dec. 6, the Cincinnati firm announced Nov. 30. Ortho is the manufacturer of Ortho-Est brand of estropipate tablets, approved via an ANDA in 1991. Abbott's Ogen is the innovator, approved for estrogen replacement therapy and prevention of osteoporosis; the osteoporosis indication is protected by Waxman/Hatch exclusivity until 1995. In September, Watson Labs received an ANDA approval for estropipate. For Duramed, the product marks a return to the estrogen replacement therapy market. The company was one of several firms that recalled generic conjugated estrogen products when FDA set new bioequivalence standards. Duramed is working with Schein on a new generic conjugated estrogens product.

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