J&J Ditropan XL Goes Generic
This article was originally published in The Pink Sheet Daily
Executive Summary
Impax/Teva launching 15 mg strength, and Mylan joins with "authorized" generic as well as its own version of the 5 mg and 10 mg strengths.
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Johnson & Johnson's overactive bladder treatment Ditropan XL (oxybutynin extended-release) is facing generic competition after a protracted legal and regulatory struggle. Mylan is launching the 5 mg and 10 mg versions of the product with 180-day generic exclusivity. Under an agreement with J&J, it is also launching the 15 mg strength as an "authorized" generic (1 (Also see "Mylan And J&J Cut A Deal For Generic Ditropan XL" - Pink Sheet, 21 Dec, 2005.)). Impax has generic exclusivity for the 15 mg dose. According to IMS data cited by Mylan, Ditropan XL had U.S. sales of approximately $380 mil. during the 12-month period ended June 30, 2006, with more than 82% of the volume in the 5 mg and 10 mg strengths. In separate releases, the generic firms announced Nov. 10 that the products had been approved and were launching immediately. Impax' noted that its "version of generic Ditropan XL 15 mg is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva." "Teva plans to begin marketing the product immediately," Impax said. Impax has tentative approval for the 5 mg and 10 mg strengths. Despite positive court rulings on the patent challenges, approval of the generics appeared to be held up by a citizen petition filed by J&J. The delay was cited recently by Mylan's CEO Robert Coury as among the reasons that FDA's generic approval process should be overhauled (2 (Also see "FDA “First Generics” Policy Not Enough, Mylan CEO Says" - Pink Sheet, 1 Nov, 2006.)). -M. Nielsen Hobbs ([email protected]) |