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…agreement with a potential generic sponsor that involves a transfer of value from the brand to the generic without authorizing immediate generic market entry. As we explained in our last…
…anything of value in exchange to limiting or foregoing entry of a generic drug product. “Anything of value” includes an exclusive license or promise that the brand company will not…
…an ICH proposal, and other efforts to expedite generic approval. As Commissioner Gottlieb points out, FDA has made great strides in streamlining the generic review process in the last few…
…notified of any agreement between a branded drug/biologic company and a generic/biosimilar company, or between two generic companies or two biosimilar companies, that relates to (1) “the manufacture, marketing, or…
…“Healthy Competition: The Case for Generic and Follow-On Biologics.” The report, authored by Gregory Conko, states: [M]any groups have sought the creation of a new abbreviated regulatory pathway for generic—or…
…Act of 2008” (H.R. 6378). According to an Energy and Commerce Committee Republicans press release, the bill: Gives FDA the authority to debar any company or individual who is convicted…
…Book. The patents have continued to be listed in the Orange Book, even today. Then along comes FDA’s May 2008 Letter Decision concerning 180-day exclusivity for generic PRECOSE (acarbose) Tablets. In…
…judgment action concerning 2 other Orange Book-listed patents. In the instant case – Dey – Sepracor listed 6 patents in the Orange Book covering XOPENEX. One generic applicant, Breath, submitted…
…the presumption of illegality] if the settlement allowed no generic competition until patent expiration.”). Significantly, DOJ explicitly states: “That is so even if the parties believed that the patentee would…
…costs of prescription drugs. These ‘pay for delay’ agreements between brand name and generic drug companies deny consumers the benefits of generic drug competition,” according to the letter. On January…
…for FDA’s interpretation of FDC Act § 505(j)(5)(D)(i)(IV) is generic OPANA ER (oxymorphone HCl) Extended-release Tablets, 5 mg, 10 mg, 20 mg, and 40 mg. According to FDA’s Paragraph IV…
…FTC v. Bisaro. As discussed in a recent Washington Legal Foundation Legal Opinion Letter, in that case, the FTC attempted to broker a deal between competing generic drug companies by…
…company’s comments submitted to FDA in response to the Genzyme petition that the MMA applies in this case “because patent information on the ‘116 patent was submitted a second time…
…to companies that plan to submit (or have already submitted) to FDA ANDAs for generic versions of reference listed drug products with old (i.e., pre-August 2003) Orange Book patent listings….
…Sandoz’s October 2010 Complaint seek to create. Sandoz’s October 2010 Complaint requests a declaratory judgment that the ‘602 patent is invalid and unenforceable, and that Sandoz’s proposed generic ELESTAT drug…