I recently used the saga of Abbott’s TriCor (fenofibrate) product life extension tactics for an FDA citation to support the use of multiple RLD’s in a 505(b)(2) application. I also think the story is instructive to the 505(b)(2) industry as to how even slight changes can be used to develop your own strategy.
Recall that fenofibrate is a 30+ year-old drug. Abbott introduced the product as a capsule. Teva filed an ANDA and Abbott sued, triggering the 30-month stay. During this stay, Abbott introduced a tablet version and withdrew the capsules, nullifying Teva’s generic. Teva then filed an ANDA for the tablets. Abbott sued, again triggering the 30-month stay during which it changed the dose, nullifying, once again, Teva’s generic. Teva enlisted 25* state attorneys general to file a suit in federal court in Delaware alleging that Abbott has illegally used “product switching” to avoid generic competition. A more legal-based review is here.
From the angle of a potential 505(b)(2) drug developer this is good news. First, it shows that even a small change can be patented to frustrate a generic competitor. Second, it shows that a small change can be promoted to great effect.
Abbott made a change in dose 54 mg and 160 mg tablets to 48 mg and 145 mg respectively by increasing the bioavailability of fenofibrate through a patented process. This “lower dose” was approved by FDA based only on a bioequivalence (BE) study. But by making this dose change, the generic competition was postponed through 2018. This is a good 505(b)(2) strategy: improving the bioavailability of a drug currently on the market or even one that is currently generic will cause a different dose. Coupled with a different dosage form, physicians would be offered a new choice for their patients. Camargo is currently engaged to do precisely this strategy – we are developing new formulations with a change in dose and dosage form.
As quoted in the WSJ, “(a)ny suggestion that new formulations did not offer patients benefit is false,” says Abbott spokeswoman Melissa Brotz. The change from capsule to tablet reduced the food effect, a benefit worth examining for 505(b)(2) projects. The lowering of dose doesn’t offer any benefits to patients since it is BE. Nonetheless, marketing and ads trumpeting’ same efficacy -lower doses’ probably has reaped millions (billions?) for Abbott. And can for 505(b)(2) drugs too.