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This is a putative class action in which the Plaintiffs, members of a putative class of end-payor purchasers of certain pharmaceutical products, allege that the Defendants, manufacturers of certain pharmaceutical products, engaged in exclusionary conduct impermissible under antitrust laws by pulling one product, Asacol mg, from the market at the same that it introduced a new product, Delzicol. This case also involves a separate plaintiff class of direct purchasers. The approval of the proposed settlement of the claims of that class awaits a final fairness hearing. Factual Background. Regulatory Background. Even after the FDA approves an NDA, the agency continues to monitor the safety of the drug and retains the authority to withdraw its approval if it finds that the drug is not safe or effective.
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Asacol, which is mesalamine - derivative of 5-aminosalicylic acid.
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There are three patents protecting this drug and one Paragraph IV challenge. This drug has twenty-one patent family members in seventeen countries. There are twenty-eight drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Start https://www.blueskydrugs.com Trial.
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