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In exchange, generic firms gain an abbreviated pathway to market by relying on the brand’s safety and efficacy data, provided they can navigate the patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book

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Melatonin synthesis was evaluated by measuring urinary 6-sulfatoxymelatonin, the primary metabolite of melatonin, which increased 1.6-fold in the Epitalon group relative to placebo