When Is Identity of Medical Ingredients Determined for an ANDS?

Apotex Inc v. Canada (Health) 2013 FC 1217 Kane J
            Apo-telmisartan / MICARDIS

The abbreviated new drug submission process allows a generic manufacturer to obtain an NOC for its generic version of a new drug without submitting safety and effectiveness data, if it can establish that its generic version is the “pharmaceutical equivalent” of a Canadian reference product: Food and Drug Regulations C.08.002.1(1)(a). "Pharmaceutical equivalent" means a drug that contains identical amounts of the “identical medicinal ingredients,” but that does not necessarily contain the same non-medicinal ingredients: C.08.001.1. But what does “identical medicinal ingredients” mean, and at what point in the drug production and delivery cycle is identity established?

So, suppose the pure API for the branded product for which an NOC has been granted is a weak base, but it is formulated as a salt form. Can the branded product be used as a reference product if the generic drug is formulated as a pure base? That is, are the salt and the base considered to be the “identical medical ingredient”? Alternatively, once the tablets are swallowed, the salt of the branded product dissolves into the acid and base, and the active moiety in the blood stream is again the base. Can the branded product be used as a reference product on the basis that the medical ingredient is identical in the bloodstream, even if it is not identical in the tablet?