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LILLY GETS NALFON COLOR CONSENT ORDER REQUIRING GENERIC

Executive Summary

LILLY GETS NALFON COLOR CONSENT ORDER REQUIRING GENERIC fenoprofen calcium tablet manufacturers American Therapeutics, Par Pharmaceutical, Rugby Labs, and Chelsea Labs to change the color of their 600 mg tablets from a yellow color similar to that of Naflon. The companies are "permanently restrained and enjoined from manufacturing or selling fenoprofen calcium in an appearance confusingly similar to the appearance of plantiff's Naflon product, and, in any event, not in any form of a yellow color," the consent order and final judgement said. The ruling was filed in the U.S. District Court for the District of New Jersey on Oct. 13. Lilly filed a complaint on Sept. 22 claiming that the companies "copied Lilly's trade dress deliberately" and that "false representation and false designation of origin have caused irreparable damage to Lilly's business and good will, and will continue to do so unless restrained by this court." A temporary restraining order was issued against the four companies on Sept. 23. The consent order and final judgement states that the companies "agree that plantiff has protectable rights in the appearance of its fenoprofen calcium tablet in the form marketed from 1977 to the present, and that the distribution of ]the companies'[ fenoprofen calcium tablets in the form distributed in the period from Aug. 17, 1988 to Sept. 23, 1988 constitutes unprivileged imitation and passing off." American Therapeutics, Par, Chelsea, and Rugby are four of 14 companies currently in the process of producing and/or marketing fenoprofen calcium tablets. The other firms are Lederle Labs, Mylan Pharmaceuticals, Watson Labs, Quantum Pharmics, Pharmaceutical Basics, Hasley Drug, Purepac, Danbury Pharmacal, Cord Labs and Zenith. Lilly's patent for fenoprofen calcium ran out on Aug. 17, 1988. Par, Chelsea, and Rugby "have represented that they intend to manufacture and sell their 600 mg fenoprofen calcium as a white tablet and plantiff has represented that it has no objection to that color," the consent order and final judgement points out. The ruling notes that companies may choose to pulverize their remaining inventory of the tablets and reconstitute them into white tablets or they may choose to apply a white coating to the tablets. According to FDA, either action would require the filing of a supplemental ANDA. Since the firms are under a court order, the applications may receive expedited reviews, FDA said. Firms deciding to reformulate their tablets with a new color will be required to receive supplemental approval, according to FDA. An exception to that requirement is when the desired color is developed after certain ingredients are removed from the tablets, the agency noted. American Therapeutics decided to take that route and has reintroduced its fenoprofen calcium 600 mg tablets in a peach color. Par said that it is producing white fenoprofen calcium tablets by taking out color additives, and therefore, is not required to submit a supplemental ANDA. The four companies are required to pay damages to Lilly under the consent order and final judgement. Chelsea and Rugby, which are cited under the parent firm Rugby-Darby Group, are to pay $ 30,000, and Par must pay $ 5,000 to Lilly, the order states. American Therapeutics is required to pay $ 10,000 in damages. The companies are also "permanently restrained and enjoined from advertising or promoting their fenoprofen calcium tablets in a manner likely to cause confusion with plantiff's Naflon product," the ruling said.
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