NOVEN CLAIMS GENERIC FENTANYL DELIBERATELY BLOCKED BY CITIZEN PETITIONS

Noven Pharmaceuticals' efforts to bring a generic version of Johnson & Johnson's (J&J) Duragesic transdermal pain patch to market are being deliberately blocked by a "suspicious" string of citizen petitions, the company claimed in a recent filing with the FDA.

The citizen petitions represent an orchestrated campaign to derail Noven's abbreviated new drug application (ANDA) for a generic version of Duragesic (fentanyl), the company said in the Dec. 30, 2004, filing. Noven submitted the document in response to a Dec. 3, 2004, citizen petition filed by Washington, D.C.-based law firm London & Mead.

Noven contends this is the fourth citizen petition filed against its ANDA within a few months. Although the challenges were not all filed by the same entity, Noven alleges that the petitions were purposely coordinated to appear shortly before J&J's exclusivity on Duragesic ends Jan. 23.

"The congruity of these petitions, all being filed just before exclusivity expires, is more than suspicious; it is conclusive of a blatant attempt to thwart the will of Congress and the public's interest in lower cost medication by, at the very least, delaying FDA approval of generic transdermal fentanyl products," Noven said in its response. "This is done simply by piling onto FDA reviewers more and more last minute petitions to which the agency understandably desires to respond."