Informative Research

What Will Happen When Viagra Goes Generic?

By Jim Edwards
October 21, 2009

Pfizer will lose its patent for Viagra on March 27, 2012, according to the U.S. Patent and Trademark Office, at which point any drug company will be able to make and sell a cheap "generic" version of the blockbuster erectile dysfunction (ED) drug. Doctors and lawyers believe that the expiration of Pfizer’s monopoly on the drug will be good news for patients, as it will force competition between Pfizer’s Viagra and the new generic versions, dramatically driving down the price not only of Viagra but also of Eli Lilly’s Cialis and Bayer’s Levitra.

However, increased options and cheaper prices for patients will lead to some confusion in the marketplace as Pfizer defends the reputation of its original brand and pharmacies become flooded with copycat pills, many of which may be made in China. Here are some signs to watch for – and some warnings to heed – in the run-up to the launch of generic Viagra in the U.S.

Viagra, Cialis and Levitra are the only ED drugs currently allowed by the FDA in the U.S. Viagra, as the oldest of the three, will lose its monopoly status first. (Levitra expires in 2018 and Cialis expires between 2017 and 2020.) Once the patent expires, the floodgates will open and consumers will likely be bombarded with advertising for cheap generic sildenafil citrate (legally, they will not be able to use the brand name "Viagra"). Until now, Pfizer has raised the price of Viagra between 5% and 11% every year, to $14 per pill at the wholesale level. That price will plummet.

Quick Facts About Viagra

Viagra was approved by the FDA in 1998 and their patent expires on March 27, 2012, at which time generic sildenafil citrate (the main ingredient in Viagra) products will saturate the market and lower the price of ED medications.
One option for Pfizer upon Viagra’s patent expiration is to “stay the course” and market itself as the original ED pill. More than 25 million men have used Viagra, and many may not want to switch.
A second option is for Pfizer to apply for OTC (over-the-counter) status for Viagra with the FDA. Pharmacist approval would be needed.
A third option is to license the original recipe of Viagra to other companies while producing an “upgraded” version of Viagra that can continue to hold value as a patented product.
Viagra is available online at AccessRx.com.

Pfizer May Feel Legal Pressure From Generics

As the date approaches, consumers may see generic drug manufacturers making legal moves to end the Viagra patent before its deadline is up, according to Henry M. Sneath, a partner at Picadio Sneath Miller & Norton, in Pittsburgh, and a vice president at DRI, the voice of the corporate defense bar. Companies will either file with the FDA to launch generics ahead of the deadline or sue Pfizer claiming its patent is invalid. "As patents near their end generic companies tend to be more aggressive in jumping into the marketplace," Sneath says.

One problem for Pfizer is that its patent on sildenafil citrate – the active ingredient in Viagra – has been ruled invalid in China and the United Kingdom. Two other patents covering the methods for manufacturing Viagra remain in place, and thus Pfizer has maintained its monopoly on the drug in the U.K. But China has become a center for the generic "Viagra" often advertised in email spam. Doctors caution that generic sildenafil citrate from foreign companies is not safe; selling it in the U.S. is illegal.

Even if a successful legal challenge knocks only a few months off the life of the U.S. Viagra patent, it will be worth it for the prevailing company – Viagra sales are $1.9 billion per year. Even one month’s sales are worth $158 million. Thus consumers can expect to see Pfizer spend millions of dollars in legal fees defending the drug.

Pfizer Is Mum About Its Post-Patent Plans

Pfizer declines to say how it will handle post-patent Viagra. A company spokesperson said "We will not comment on future plans for Viagra. Pfizer benefits from having options when our medicines go off-patent. We currently have a thriving generics business, and also will have a consumer health business at such time as we satisfy the closing conditions and acquire Wyeth. As with all our medicines, we continually explore options for patients to have access to them."

One option is for Pfizer to continue to make and sell "the real thing," in hopes of benefiting from worries over the quality of generic sildenafil made by companies with no experience in manufacturing ED drugs. The company may even be able to charge a slight premium for the assurance and quality of its brand name. Real Viagra as supplied by Pfizer will likely continue to come packaged with an RFID chip, a high-frequency electronic "fingerprint" tag, a barcode, and labels printed in color-shift ink.

That "premium" will still feel like a huge discount for patients. Generic competition sometimes reduces drug prices by up to 80 percent. Bayer and Lilly will likely be forced to follow suit. As Lilly has a once-per-day version of Cialis, and as its effects last up to 48 hours, it may still be able to charge a slight premium over generic sildenafil.

More Patients May Seek ED Treatment Due to Affordability

Demand for generic sildenafil will likely increase as doctors prefer to prescribe cheaper, older drugs with proven safety records, and health insurance plans cover generic drugs, according to Dr. Dennis Lin, a psychiatrist and physician-in-charge of the psychosexual medicine program at Beth Israel Medical Center in New York. "Most likely, the logical, the ethical thing to do is prescribe the generic. It’s cheaper, especially if the patient is paying out-of-pocket," he says.

Another possibility is for Pfizer to request that the FDA give Viagra some kind of "behind-the-counter" status in pharmacies. This would allow patients to buy the drug without a prescription as long as they discuss their medical history with a pharmacist first. The U.K. has already allowed pharmacy sales this way. Pfizer has said it will not apply for "over-the-counter" status – making it the same as cough and cold medicine – because Viagra causes serious cardiovascular side effects in patients taking nitrate drugs such as nitroglycerine for heart conditions.

Lastly, Pfizer, which was fined $2.3 billion by the FDA in 2008, may license its original recipe to other companies while it pursues a new version of the drug – perhaps with an extended release formulation similar to Cialis. Topical ED ointments are even a possibility in the future. This would give Pfizer a new monopoly on a new brand, which it could claim is more advanced than Viagra. Such "me-too" products are common in the pharmaceutical industry.

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Informative Research

What Will Happen When Viagra Goes Generic?

Quick Facts About Viagra

Pfizer May Feel Legal Pressure From Generics

Pfizer Is Mum About Its Post-Patent Plans

More Patients May Seek ED Treatment Due to Affordability

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