Is Over-the-Counter Cialis Coming to a Pharmacy Near You?

Soon men may be able to go into the drugstore and pick up some Cialis for their erectile dysfunction without stopping at their doctor's office for an uncomfortable conversation first.

Eli Lilly (NYSE: LLY  ) and Sanofi (NYSE: SNY  ) announced a deal on Wednesday that will allow Sanofi to pursue regulatory approval of an over-the-counter version of Cialis in the US, EU, Canada, and Australia. The terms of the partnership weren't disclosed, so it's impossible to say whether Eli Lilly, which sells the prescription version, got a good deal licensing off the over-the-counter version.

Eli Lilly made a good choice to partner the over-the-counter version since it doesn't have a consumer health division. Sanofi bought Chattem a few years ago for its marketing channels and launched an over-the counter version of its prescription allergy drug, Allegra, in 2011. Merck (NYSE: MRK  ) , which launched a generic version of Claritin, would have been a good option, but the consumer health division is in the process of being transferred to Bayer. Johnson & Johnson was the other obvious choice having taken Zyrtec OTC after purchasing Pfizer's (NYSE: PFE  ) consumer health division.

Source: Eli Lilly

Sanofi will likely launch the drug after the patents expire in 2017. Switching to over-the-counter is a good way for companies to retain some sales when generic versions flood the pharmacy. It's easier to compete with generics on the pharmacy floor where many consumers will pick the name brand product even if it costs a little more than it is to compete with generic prescription medications because pharmacists default to the generic unless the doctor or patient explicitly asks for the brand-name drug. Merck sold $471 million worth of over-the-counter Claritin last year; not exactly the blockbuster it once was, but that's still a solid chunk of change.

Getting an over-the-counter version approved is far from guaranteed. Pfizer tried to get its erectile dysfunction drug, Viagra, moved to over the counter in 2007, but eventually withdrew its request, possibly because the FDA gave the company an indication that it wasn't approvable as an over-the-counter medication.

To switch to over-the-counter status, the FDA will need to be convinced that patients can successfully diagnose their condition, which doesn't seem too hard. But the agency may be worried that patients' erectile dysfunction is a sign of another problem, such as clogged arteries, which won't get treated if patients self-diagnose.

The FDA will also want to make sure patients can take Cialis safely. The drug isn't supposed to be taken with nitrates for heart problems or alpha-blockers for the treatment of benign prostatic hyperplasia, an enlargement of the prostate gland. It's also not supposed to be taken by people that shouldn't be having sex because of cardiovascular issues.

The FDA may require Sanofi to do a usability study to confirm patients can correctly differentiate whether or not they can safely take over-the-counter Cialis. The agency is making Pfizer run a trial to see if patients can safely take its cholesterol drug, Lipitor, over the counter, although that's a little more complicated because it requires patients to get their own blood test.

Sanofi and Eli Lilly likely face an uphill battle to get an over-the-counter version approved because the FDA may ultimately decide that the risks to patients outweigh the limited potential benefit -- convenience and avoiding that uncomfortable conversation. Still the potential reward for the companies if the FDA decides to approve over-the-counter Cialis makes it worth pursuing even if it is a bit of a long shot.

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  • Report this Comment On June 02, 2014, at 6:21 AM, jdmeth123 wrote:

    With the ability to order drugs from the internet if there was a problem with self diagnosed men it would have been apparent already. Or it could be anyone savvy enough to use the internet to order drugs would have at least seen a doctor first. Something called Siltada (two thirds Viagra, one third Cialis) does wonders. $.75 per dose in quantity.

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