Under the recently enacted MMA, agreements executed on or after 7th January, 2004, between branded drug manufacturers and generic drug applicants must be filed with (and approved by) the FTC and the Assistant Attorney General. See, eg, URL: http://www.ftc.gov/os/2004/01/040106pharmules.pdf.
2.
Docket No. 00–03481-CV-AJ (S.D. Fla.). In June, 2002, Andrx voluntarily dismissed its claims against SkyePharma with prejudice.
3.
See Teva Pharm USA, Inc v US FDA, n.3 (DC Cir. 1999) (pre-MMA, a district court decision in subsequent filer's case triggers first filer's exclusivity whether or not the first filer is in a position to use it).
4.
See Elan Corp v Andrx Pharmaceuticals. Complaint dated 28th January, 2005, Case No. 05-CV-60158; see also Andrx 10-Q, filed 7th November, 2005, at 26 (‘However, since we have sold and are continuing to sell our generic version of Naprelan, an adverse determination could have a material adverse effect on our business …’).
5.
See Andrx Pharmaceuticals v Elan Corp, order Granting Motion for Judgment on the Pleadings, dated 24th April, 2003, Case No. 00–3481-CV-Jordan (SD Fla.).
6.
See Andrx Pharmaceuticals v Elan Corp, Elan's Submission of the Court of Appeals’ Mandate of 27th September, 2005, dated 19th October, 2005, Case No. 00–3481-CV-Jordan (SD Fla.).
