Thursday, September 29, 2005

Mylan prevails against Alza over Ditropan (oxybutynin)

Alza, of Mountain View, CA (a subsidiary of Johnson & Johnson Co. of New Brunswick, NJ) said the U.S. District Court for the Northern District of West Virginia, ruled Sept. 27 that its patent on Ditropan XL (oxybutynin chloride) extended release tablets is invalid and that Mylan Laboratories Inc. does not infringe Alza's patent. The company says it will appeal the decision to the Court of Appeals for the Federal Circuit in Washington, DC.

from businessweek:

Alza Corp., owned by health-care products company Johnson & Johnson Inc., said Wednesday that it will appeal a federal district court decision striking down the validity of its Ditropan overactive bladder treatment patent.

The court ruling allows Mylan Laboratories Inc. to step closer to marketing a generic version of the drug. At issue is the extended-release version Ditropan XL, also known as oxybutynin chloride. A West Virginia federal district court ruled that Mylan's version does not infringe patents held by Alza.

In January, Mylan received tentative approval from the FDA for the 5 milligram and 10 milligram tablets of the drug. Tentative approvals usually become final after the resolution of patent issues.


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