Drug Competition, the Patent Game, and Generic Cialis

Photo Credit: by Nazreen Banu

Affordable drugs are something of a misnomer here in the United States. Everyone touts the desire to drive prices down, yet we’re paying more for our medications than virtually everyone else in the modern world.

With recent upheavals in Pfizer’s goliath Viagra patent expiration, and subsequent patent extension to 2020, the impacts are being felt across all big pharma—even with its deal with Teva Pharmaceuticals to deliver a generic by the end of this year. With the intricate dance happening in the pharmaceutical industry, it’s no wonder the public has a hard time following along. It’s virtually impossible to get a straight answer these days on when generic versions of drugs will be available.

Cialis is no exception. With patents set to expire this year, there’s a lot up in the air on how its manufacturer will respond and what the FDA might do. Let’s take a closer look.

What’s the history behind Cialis?

Cialis (tadalafil) is an erectile dysfunction (ED) drug manufactured and marketed by Eli Lilly. Approved by the FDA on November 21st, 2003, it became the third drug of its kind—after Viagra (1998) and Levitra (8/2003). As of 2015, Cialis overtook Pfizer’s Viagra to become the top-selling ED drug worldwide. Part of this has to do with the nature of the medication. Cialis is taken daily, active for 36 hours, and provides erection support only when sexually aroused (a more natural approach). Versus Viagra, which is short-acting and taken right before sex. The main side effects of Cialis are also a bit more mild – muscle cramps, as opposed to Viagra’s vision distortions.

What is Hatch-Waxman and how does it apply to Cialis?

Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, is a law signed in the United States in 1984 which was meant to encourage the development of generic drugs. ‘

Before Hatch-Waxman, generic manufacturers couldn’t even think about working on a generic equivalent until the brand-name drug’s patent had expired—or risk being in violation of the patent.

The new bill changed things, by negating the patent law in part. Instead, the legislation allowed a generic company to experiment with a patented drug as part of their own FDA approval.

While this was good news for generic companies, brand-name pharma still wanted to protect their interests. In order to make everyone happy, the bill gave brand-name companies the ability to delay the generic version from entering the market by filing a lawsuit alleging infringement. By doing so, the brand-name pharma gets an automatic 30-month delay in the regulatory process. This means that even though the generic company can work on their equivalent, it may take years before they can even introduce it to the public.

This injunction process has ended up having some unintended consequences. To boil it down, it’s given brand-name pharma a reason to file patents for aspects of their drug that would normally never be patented – simply to have more reason to extend their patents, and point toward infringement.

Now with the case of Cialis, Eli Lilly is actually looking to avoid the whole thing by trying to flip their popular ED drug from a prescription, to over-the-counter (OTC). Whether or not this move will work or come to fruition, is anyone’s guess at this point in time. But its impact will be felt across the board. More on that in a minute.

Generic vs Over-the-Counter (OTC) Cialis

A generic equivalent will still require a prescription in order to obtain. Not so with an OTC version. This could mean a massive hike in sales and a bypass for men who’d rather pay for the medication without having to talk to their doctor.

Steve Francesco, president and CEO of Francesco International, New York City, an expert in the Rx-to-OTC switch arena, has recently said, “Cialis is different from Viagra in that Cialis has a number of dosages, and presumably it would be the lower dose that would be switched. Cialis is considered to be safe and effective, and it has a much better side effect profile than Viagra.”

With Viagra hanging on to its patent until 2020, and Teva Pharmaceuticals introducing its generic equivalent at the end of the year, the impact of OTC Cialis becomes a waiting game. Here’s the way it could impact things: if OTC Cialis comes out before the generic Viagra hits the market, it could cause men who would ordinarily have gone to Viagra or its generic to switch to Cialis. If it comes out afterward, the impact is less severe.

When will generic or OTC Cialis be available in the United States?

The patent for Eli Lilly’s Cialis expires this year (2017). So far, there isn’t a definitive answer on when a generic version may be available. In 2014, talks began proposing a partnership with French Drug maker, Sanofi to make Cialis available over the counter in the United States, Europe, Canada, and Australia. So far, those talks are still just that—talk. While an agreement was reached between the two drug companies to deliver an OTC version of Cialis, it’s unclear whether the FDA would allow such a joint venture to occur. As of right now, there are no FDA approved generic or OTC versions of this drug, and any pharmacy claiming there is one should be approached with caution.

The FDA will be considering whether the prescription requirements are necessary for the protection of the public. For example, those patients who are currently on a blood pressure medication would essentially be taking an additional dose, as Cialis is also used to treat blood pressure. Males who take a nightly dose, may want to ask their healthcare provider if it’s worth switching to Cialis to approach both issues at once.

The FDA will also look at Cialis’s toxicity, the potential for harm, method of use, and other information needed to deem it safe for the public.

If approved before the patent expires, Cialis would have 3 years of marketing exclusivity in the OTC market. If the approval doesn’t happen until after the patent expires, the active ingredient could also be marketed by other companies. In essence, this means Eli Lilly and Sanofi will want it to switch to OTC right before the patent expires. So keep your eyes peeled later this year.

As long as the laws in the US are set up to allow big pharma to game the system, we’ll continue to have higher drug prices and longer waits on generics. Self-preservation is a strong impulse, and it’s evident even in big pharma when profit margins could take a dive. In the meantime, there are always more affordable options, as well as generic versions of Cialis legally approved for sale in reputable Canadian pharmacies, such as this one.

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Carissa Andrew considers herself a triple threat: write, design and marketing. Her passion lies in mixing these three together with creativity and sass.