Generic ED Meds Approved By The FDA

December 21, 2020

4 mins

Viagra was the first ever medication approved by the United States Food and Drug Administration for erectile dysfunction (ED). That first-mover status led to a whole host of advantages: it was the only ED med on the market for about 5 years, giving manufacturer Pfizer unfettered access to this new market. To this day, Viagra is still the most well-known ED medication.

Viagra is synonymous with ED, ubiquitous as the first brand people think of. It's attracted some tongue-in-cheek nicknames along the way too - Vitamin V, the little blue pill, among others. 

But since then, more branded drugs and cheap, generic ED meds have become available for erectile dysfunction. Viagra is no longer the lone king of the hill.

Here's a breakdown of all the FDA approved generic ED medications. They all work by the same mechanism – inhibiting PDE5 (the phosphodiesterase-5 enzyme) – because it's proven so effective at treating ED in the roughly 50% of guys ED happens too.

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Quick Facts On Generic ED Meds

Viagra was approved in 1998, and a generic was available in the U.S. in 2017. 

Cialis was approved in 2003, and a generic was available in the U.S. in 2018.

Levitra was approved in 2003, and a generic was available in the U.S. in 2018.

Which ED meds are generic and when?

When Was Viagra Approved?

Viagra (sildenafi citrate) was approved on March 27, 1998 for the treatment of erectile dysfunction. Pfizer Pharmaceuticals held the patents and FDA market exclusivity...and Viagra was an absolute blockbuster. By 2012, Viagra was generating over $2 billion in revenue per year for Pfizer! Amazingly, branded Viagra cost as much as $90/dose when it was first introduced.

Clearly there were a lot of dudes ready and waiting for a good solution to ED. 

Is Viagra Generic?

Pfizer went to battle in the courts to keep a generic version of Viagra from coming to market for as long as possible (no wonder $$). It's common practice for pharmaceutical companies: they've spent money, time, and risk developing a new medication, and they want to maintain a stranglehold on the market for as long as possible.

But it's also typical for generic drug manufacturers to try to start making their own cheaper versions of the same effective ingredient – without any of the same branding, of course – in the 10 to 15 years after the branded drug's approval. In that timeframe, drug patents and exclusive market rights granted by the U.S. FDA start to dissipate, though it still takes some work on the part of intellectual property lawyers (as the saying goes, no matter what happens in court, lawyers always win ($)).

The walls around the Viagra castle finally came down in December of 2017, though not as dramatically as you might expect. Rather than see Viagra sales cannibalized entirely by generic competition, Pfizer launched their own generic sildenafil citrate a week before the first true generic, from Teva Pharmaceuticals. Both landed in December 2017, at discounts of about 30-40% off the original. 

It wasn't until about 6 months later, in the summer of 2018, that more generic sildenafil tablets started to hit the market, forcing prices even lower. Today, you can find generic sildenafil for as low as $10.

When Was Levitra Approved?

Viagra reined supreme in the ED landscape for about five years, precious and powerful time to be the sole option in a sought-after marketplace, and the reason Viagra is still a household name today.

While Levitra has never had the same clout or brand recognition as Viagra or Cialis, it was second to market. 

Levitra (vardenafil hydrochloride) was approved by the FDA on August 19, 2003, becoming the second orally delivered PDE5 inhibitor for the treatment of erectile dysfunction. It was marketed and sold by Bayer Corporation.

Is Levitra Generic?

Today, like Viagra, Levitra is also available in generic forms from multiple manufacturers. The first generic version of vardenafil was approved by the FDA in October of 2018.

When Was Cialis Approved?

Cialis (tadalafil) came hot on the heels of Levitra and was approved by the FDA on November 21, 2003.

With a strong marketing push, Eli Lilly quickly rocketed Cialis to similar brand recognition as Viagra - remember the distinct side-by-side bathtub ads?

Cialis caught on for its distinct characteristics: it's known for keeping guys prepared for intimacy over a much longer window than its competition. Cialis "works" for about 36 hours – you can get intimate any time – while Viagra requires intimacy within about 4 hours. That longer window meant couples going away for a weekend could be ready at any time (perhaps why those couples looked so peaceful in their side-by-side bathtubs), rather than take a medication an hour or two before intimacy. 

That's precisely why Cialis is the most popular ED medication, generic or branded.

Cialis is also known for alternative lower dose options (2.5 and 5 mg tablets) that can be taken daily rather than on-demand. For some guys, it's a good fit to keep them ready for action at any time. 

Is Cialis Generic?

Tadalafil is also available as a generic, at much lower prices than branded Cialis. The first generic tadalafil was launched in September of 2018 by Teva (like Viagra), with more following.

When Was Stendra Approved?

Stendra (avanafil) was approved by the FDA on April 27, 2012. It's a late-comer and never achieved the same level of sales for owner VIVUS Inc. as its earlier PDE5 inhibiting counterparts, though it's still an effective ED medication. 

Avanafil is branded as Spedra in some other countries, as well as Zepeed.

Is Stendra Generic?

As of late 2020, avanafil is not generic yet. Because Stendra received FDA approval only ~8 years ago, it's patents have not been invalidated yet. But you can still access branded Stendra after consultation with a doctor.

Branded or generic, ED meds are easier than ever to get. Rex MD has taken the guesswork out of online ordering. with our free physician consultations and industry prices, there's little reason to go see a doc in person these days.