Assessing damages market issues for delayed generic entry in Canada

CRA has been retained in Canadian Section 8 matters to quantify sales and profits a generic manufacturer would have made if it had been allowed to enter earlier. CRA has evaluated whether earlier generic entry would have affected the total market for the molecule, how the generic share would have evolved over time, and in the case of multiple generic entrants, the share each generic entrant would be expected to capture. CRA has extensive experience in evaluating these empirical questions, including evaluation of similar molecules and the therapeutic class, the impact of provincial formulary listing on sales, and the consideration of multiple generic entrants and different orders of entry. CRA has also examined generic rebating behavior in Canada and its effect on the net price of sales for earlier generic entry. CRA’s experience in such matters covers a range of therapeutic areas and molecules, including antibiotics, ophthalmic glaucoma medications, antidepressants, anti-cholesterol medications, and blood pressure medications.