Ripe prospects for OTC switch consideration

If you were impressed by the recent switches of Nasacort Allergy 24HR, Nexium 24HR or Flonase — well-executed and model switches — well, you ain’t seen nothing yet. Because it won’t be long now before the blockbuster of blockbusters — Pfizer’s statin Lipitor — could make its way down the switch aisle. Pfizer wrapped up consumer usage studies of its cholesterol-lowering drug in December and expects to reveal the results by the end of June.

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So why now? Why would the Food and Drug Administration be willing to entertain another statin switch when in the past decade the agency had denied so many other attempts?



It’s a matter of perspective, suggested Joe Papa, president and CEO of the store-brand manufacturer Perrigo and avid switch follower. The FDA and the medical community have changed their views on how to treat high cholesterol — you don’t treat the numbers; you treat the risk factors. “It’s that move to risk factors that I think is the important question,” he said.



But Lipitor isn’t the only blockbuster switch prospect. If approved as an OTC, Lipitor will be one of approximately seven switches coming to FDA decision-makers before the end of 2016, suggested Steve Francesco, president of Francesco International and chairman of the ExL Pharma’s Rx-to-OTC Switch Summit. According to Francesco, there are at least 35 switch projects in various stages right now.



Now that the nasal corticosteroids Nasacort Allergy 24HR, and more recently Flonase, are on the market, it stands to reason Bayer’s Nasonex and Meda Pharmaceutical’s Astepro might be up for switch consideration, Papa suggested. And the recent Bayer switch of Oxytrol opens the door to other overactive bladder remedies like Pifzer’s Detrol and Detrol LA or Janssen Pharmaceuticals’ Ditropan or Ditropan XL. The overactive bladder market is a $3.3 billion opportunity, Papa suggested.



Other areas ripe for OTC switch applicants include topical analgesics and ophthalmic products, Papa said. Longer term, erectile dysfunction may be up for consideration in 2017, when patents protecting Cialis expire. Chattem acquired the marketing rights to an OTC Cialis last year.