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."
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth