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…way,” but it helps incentivize generic drug manufacturers given concers about tort liability: The Proposed Rule achieves an important public safety goal by restoring these incentives for generic manufacturers to…
…with a prospective generic manufacturer, where the settlement includes a payment from the brand manufacturer to the generic manufacturer but does not exclude competition beyond the scope of the patent….
…restrictions concerning the Company’s off-label promotion of Vascepa. We do not know when the Court will complete its review of the Proposed Settlement Order and finalize the settlement. In sum,…
…here, here and here about the CARES Act and OTC monograph reform). Under the OTC Monograph User Fee Program commitment letter, FDA committed to modify existing guidance on formal dispute…
…drug patent settlement cases. But the Complaint is also interesting to us for another reason: the FTC’s comments concerning 180-day exclusivity for Generic LIDODERM. Various FTC comments in the Complaint…
…Pharms., Inc., No. 0247 (Phil. Ct. Comm. Pleas. Dec. 2, 2011): The Philadelphia Court of Common Pleas, in consolidated litigation over generic phenytoin, dismissed all claims brought by certain plaintiffs…
…comparable whether the same patient is being treated with a generic drug or the brand drug, but because of the generic switch, the patient may be more likely to complain…
…proposed rule: At the time of FDA’s adoption of the generic drug regulations in 1992, FDA believed it was important that product labeling for the RLD and any generic drugs…
…different than those that apply to generic drug manufacturers. Indeed, it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more…
…in which brand and first-to-file generic drug manufacturers block all generic competition through settlements in which the 180-day exclusivity is ‘parked,’” says the letter. “If Congress is to effectively address…
…Opinion and Order, Hospira requested and was denied a Motion for a Stay of the Court’s Order. It was immediately clear what was coming next: an emergency appeal to the U.S….
…2009 is the earliest effective date” upon which a generic applicant “may launch its commercial generic product.” In what appears to be a case of first impression, the court issued…
…state that you are requesting FDA initiate notice-and-comment rulemaking, the Act . . . authorizes only two mechanisms for FDA to make an Rx to OTC switch: [informal] notice-and-comment rulemaking…
…agreements in which Solvay Pharmaceuticals, Inc. (“Solvay”) allegedly paid some generic drug companies to delay generic competition to Solvay’s drug product ANDROGEL (testosterone gel). The Eleventh Circuit, following the Court’s…
…Pharms., USA, 620 F. Supp. 2d 899 (N.D. Ill. 2009), Kellogg v. Wyeth, 612 F. Supp. 2d 421 (D. Vt. 2008), Schrock v. Wyeth, Inc., 601 F. Supp. 2d 1262…