MYLAN, J&J ENTER DITROPAN SUPPLY AGREEMENT
Mylan Laboratories has entered into a supply agreement with a Johnson &
Johnson (J&J) subsidiary for J&J's extended-release incontinence drug
Ditropan XL, pending a final court ruling on the firms' patent dispute. Terms
of the agreement were not disclosed, and are still subject to a number of conditions
including approval by the FTC.
J&J sued Mylan after it filed an abbreviated new drug application (ANDA)
to market 5- and 10-mg doses of the drug.
Under the agreement, J&J unit Ortho-McNeil Pharmaceutical will supply Mylan
with all strengths of oxybutynin chloride, the active ingredient in Ditropan
XL, upon a final ruling by the court. J&J will supply Mylan with the drug
earlier if another generic version of Ditropan XL enters the market, Mylan said
recently.
Mylan will also receive a non-exclusive license and pay a royalty to J&J
for the right to make and sell certain generic drugs, but the terms of that
agreement depend upon the outcome of the pending patent litigation, Mylan said.
Ortho-McNeil markets Ditropan XL in the U.S. and another J&J unit, drug
delivery system company Alza, owns the patent.
Mylan has received tentative approval from the FDA to market generic Ditropan
XL, but final approval "could come at any point," J&J said in
its third-quarter filing with the Securities and Exchange Commission.
In late September, Mylan won an initial victory in the dispute when the U.S.
District Court for the Northern District of West Virginia ruled that Alza's
Ditropan XL patent was invalid and that Mylan's version of Ditropan XL does
not infringe on Alza's patent. J&J has appealed the decision.
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