Summary
The FDA, acting with surprising speed, recently denied a Citizen Petition (CP) filed 13 Feb 2009 by Medicis (NYSE: MRX) in support of SOLODYN. If FDA's denial of this CP is not reversed, then the current 3 ANDA filers [Mylan (NasdaqGS: MYL); Barr/Teva (NasdaqGS: TEVA); and Sandoz/Novartis (NYSE: NVS)] will not be subject to a 30-month stay of FDA final approval of each of their respective ANDAs.
Analysis
Earlier today 18 Mar 2009 Teva announced that it has now launched its generic version of SOLODYN. This product launch is "at-risk" in the sense that Teva, along with Mylan and Novartis, each remain in a patent infringement battle with Medicis; each of these ANDA filers might ultimately suffer a loss in the patent dispute; and each of these generic companies might later have to pay patent infringement damages to Medicis. This current CP defeat for Medicis follows an earlier but different CP defeat also relating to SOLODYN; namely, the 03 Feb 2009 FDA decision to deny an attempt by Medicis to ensure that ANDAs must not rely upon 135 mg strength SOLODYN bioequivalence testing in relating to ANDAs for the other 2 strengths (45 mg and 90 mg) of SOLODYN. Medicis remains actively engaged in efforts to obtain additional US granted/issued patents which would provide additional patent protection for SOLODYN.
