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BIOCRAFT, QUANTUM PHARMICS AND COLMED LABS CLEAR METOCLOPRAMIDE GENERICS

Executive Summary

Biocraft, Quantum Pharmics, and Colmed Labs received ANDA approvals for 10 mg metoclopramide tabs on July 29. The generics to Robins' Reglan were approved for the "relief of symptoms associated with acute and recurrent diabetic gastric stasis." Reglan carries additional indications including uses for gastroesophageal reflux and relief of nausea and vomiting due to cancer chemotherapy. Biocraft is pricing its version between 55% and 57% below Reglan's published prices; Quantum's branded generic price is about 42% below Robins'. Biocraft's price to whslrs. is $10.50 for 100s and $47 for 500s. Quantum's suggested whsle. price for its Clopra brand is $13.86 for 100s and $65.74 for 500s. The Redbook lists Reglan's average whsle. price at $23.55 for 100s and $111.80 for 500s. Robins will be facing generic competition to its largest selling Rx product. In its 1984 annual report, the company reported that Reglan volume increased 49% to approximately $60 mil. The tablet form enjoyed only four years of marketing exclusivity. FDA approved the tablet in 1981; the I.V. "dosage was approved in 1979. Metoclopramide is Biocraft's second major post-1962 ANDA approval in the past several months. In February, the firm received the first ANDA for dysopyramide (Searle's Norpace). Colorado-based Colmed received FDA approval for one post-1962 product in the past year, chlorpropamide. The generic to Pfizer's Diabinese was approved in August 1984. Metoclopramide and propranolol were approved during the same week (see previous story). Propranolol is the seventh drug among the Top 20 retail Rx products to lose its marketing exclusivity in the past year. The other products now facing multi-source competition, excluding oral contraceptives, are Aldomet, Dyazide, Diabinese, Indocin, Darvocet-N and Motrin,

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