Why Some Generic Drugs Are Approved but Not Marketed

Article excerpt

Why would a manufacturer go through all the regulatory hoops of drug approval and then not bring its product to market? A prime example is clozapine, the generic version of Novartis' Clozaril, approved in August last year but not rolled out to pharmacies yet.

According to generic expert Edward Thwaite, head of E. W. Thwaite Associates, a consulting firm in Totowa, NJ., there are a number of reasons for this phenomenon. One is that if the product is made by a brand company with its own generic subsidiary, the company might not want to introduce the generic too soon or it could "start cannibalizing the brand."

A generic that was approved can also be mothballed if there is minimal marketing opportunity for it. Let's say an Abbreviated New Drug Application (ANDA) was submitted to the Food & Drug Administration seven years ago. By the time it is approved, the market may have dried up for the product. That situation may have occurred with captopril (Capoten), Thwaite noted. About 14 generic companies received approval for the product initially, bringing the price of the drug down precipitously. "I believe not all companies launched the product because they said, 'We may not even be able to sell our inventory,"' Thwaite recalled.

Not being able to make the generic according to ANDA specifications and difficulty in getting the bulk substance to produce the product are other reasons that some generics are still in the hangar. Citing Barr Laboratories' warfarin, approved but not yet launched, Thwaite said the delay could be a factor of the company's manufacturing capacity, or perhaps there's a problem obtaining the bulk substance. …