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BARR RECEIVES FIRST ANDA APPROVAL FOR GENERIC FORM OF ERYC,

Executive Summary

BARR RECEIVES FIRST ANDA APPROVAL FOR GENERIC FORM OF ERYC, Parke-Davis' delayed-release erythromycin, on May 4. The product, which is available in 250 mg capsules, is bioequivalent to Eryc, Barr said May 4. Barr anticipates that shipments of its generic erythromycin product will begin in mid-June. The capsules will be available at an AWP of $ 23.55 for a bottle of 100s, and for $ 111.90 per bottle of 500s. The company noted that "the estimated market for this product in 1988 was $ 40 mil. and growing." Barr added that this is its first delayed-release product and that it will fit well with its established erythromycin line, which includes E.P.S (erythromycin ethylsuccinate and sulfisoxazole acetyl), which is equivalent to Ross' Pediazole oral suspension. Barr is currently in litigation with Copley over the development and manufacture of the delayed-release erythromycin caps. The two firms signed an agreement in December 1985, which called for Copley to develop and formulate the product and to provide Barr with manufacturing instructions. Barr was responsible for the analytical work, laboratory studies, and the ANDA submission. Under the arrangement, Barr would market the product and pay Copley 8% of the net sales price for three years, after which both firms would have the right to manufacture and market the capsules. Copley filed suit against Barr on June 23, 1987 in Massachusetts, claiming that Barr "unreasonably delayed" obtaining ANDA approval, thereby breaching the agreement. Copley's suit also asserted that Barr "intends to utilize the information obtained from Copley to file an ANDA that it will claim is not subject to the agreement." Barr responded by denying Copley's claim and filing a counterclaim for not meeting the agreement terms. Barr alleges that Copley tried to foist on the company a method of manufacture that was "old and well known for many years in the drug manufacturing art."

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