Intellipharmaceutics International has announced that the US Food and Drug Administration (FDA) has granted final approval of the company's dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30mg strengths.
Commercial sale of these strengths will be launched immediately by the company's commercialization partner in the US, Par Pharmaceutical.
As the first-filer for the drug product in the 15mg strength, the company will have 180 days of exclusivity of generic sales from the date of launch in the US by its partner, Par Pharmaceutical.
The company's 5, 10, 20 and 40mg strengths were also tentatively FDA approved, subject to the right of another party or parties to 180 days of generic exclusivity from the date of first launch by such parties.
Par Pharmaceutical intends to launch these strengths immediately upon the expiry of those exclusivity periods.
Intellipharmaceutics co-founder and CEO Dr Isa Odidi noted the FDA approval of the company's application for a generic version of Focalin XR is a major milestone for the company in several respects.
"We believe that the approval represents a strong validation of our core drug development competence and our controlled-release delivery technologies.
"At the same time, we have demonstrated that we can partner with an established and well-regarded pharmaceutical company, in this case Par Pharmaceutical, to see a product through to commercialization in the United States.
"Finally, this generic product will generate our first revenues from commercial sales of a drug product in the United States and provide an enhanced level of financial flexibility to the Company," Dr Odidi added.