Intellipharma reports Par Pharma additional strengths launch of generic Focalin XR

Intellipharmaceutics International announced that its U.S. marketing partner, Par Pharmaceutical has launched the 10 and 20 mg strengths of its generic Focalin XR (dexmethylphenidate hydrochloride extended-release) capsules in the US. The USFDA had previously granted final approval to Par’s abbreviated new drug application (“ANDA”) for its generic Focalin XR capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

The launch of the 10 and 20 mg strengths complements the 15, 25, 30 and 35 mg strengths of generic Focalin XR previously launched and marketed by Par.The Company expects the remaining 5 and 40 mg strengths to be launched in the near future. Under a licensing and commercialization agreement between the Company and Par, the Company receives quarterly profit-share payments on Par’s US sales of generic Focalin XR.

Intellipharmaceutics CEO and a co-founder, Isa Odidi said that in January 2017 they announced Par’s launch, with 180 days of U.S. generic market exclusivity, of the 25 and 35 mg strengths of its generic Focalin XR. The Par launch of the 10 and 20 mg strengths will add to the revenue improvement they have realized thus far in 2017, and they look forward to their launching the remaining strengths.

Focalin XR is a drug used in the treatment of attention deficit hyperactivity disorder, is marketed by Novartis Pharmaceuticals Corporation. There can be no assurance as to when or whether the remaining 5 and 40 mg strengths of generic Focalin XR will be launched or successfully commercialized.