Viagra Patent Expiration Date Extended to 2020

Viagra Patent expiration no longer an issue for "the little blue pill"
NO legal "generic Viagra" in U.S. for several more years

U.S. men seeking a generic version of Viagra (sildenafil citrate) - the first and the most popular prescription drug for Erectile Dysfunction (ED) - are going to have to wait for a few more years. Viagra's patent, originally scheduled to expire in late March of 2012, has been extended to April of 2020. That's good news for the manufacturer, Pfizer, Inc., of course, but it's also good news for patients suffering from Erectile Dysfunction.

There has been a lot of informed speculation in recent years about what would happen when Viagra finally did become available in generic form. Acclaimed pharmaceutical industry observer and reporter Jim Edwards has written about that issue for this site (links are below). Several drug companies were poised to leap on the opportunities presented by the expired patent - most notably, Teva Pharmaceuticals, which gained tentative approval from the Food and Drug Administration (FDA) to market a generic version of Viagra.

In March of 2010, however, Pfizer sued Teva for patent infringement, based on a second Pfizer patent which runs until 2019. This second patent is sometimes referred to as a "method-of-treatment patent." Pfizer argued that even though sildenafil was to come up for grabs in 2012, Pfizer should retain exclusive rights to market it as an ED treatment until 2019. Pfizer ultimately prevailed against Teva in a 12-day bench trial held in the summer of 2011, and it was declared that the company's Viagra patent would stand solid through 2019.

Early in 2012, Pfizer was granted an additional six months of U.S. patent protection for Viagra, because the company is studying the effect of another one of its products containing Viagra's active ingredient, sildenafil, in children with pulmonary hypertension. With this latest development, Pfizer's patent for Viagra stands through April of 2020.

Consequently, there is still no legal "generic Viagra" available in the United States - despite what some online advertisers claim - nor is there an over-the-counter (OTC) version of this drug yet. Prescription Viagra, the "little blue pill," remains the only legal option for U.S. shoppers seeking the proven ingredient sildenafil as a treatment for Erectile Dysfunction.

ED drugs: the state of the market today

Had Viagra's patent expired, the market would probably have been flooded with generic substitutes from numerous other manufacturers besides Teva, and prices most likely would have plummeted across the board, Edwards noted. Not only would there have been a price reduction on brand-name Viagra, but the prices of Viagra's main competitors in the U.S. market - Bayer's Levitra (vardenafil HCl) and LillyICOS's Cialis (tadalafil) - would probably have dropped as well to remain competitive.

Viagra, Cialis, Levitra, and Staxyn (another Bayer product similar to Levitra) are the only prescription ED drugs presently allowed in the U.S. by the FDA. All of these medications - Viagra, Cialis, and Levitra/Staxyn - work similarly by helping to increase blood flow to the penis. They are in a class of drugs known as PDE5 inhibitors. Currently Levitra's patent is set to expire in 2018, and Cialis' patents expire between 2017 and 2020.

Since Viagra's patent expiration is no longer an issue, the big question is how the patent extension will affect the marketplace. As indicated above, Pfizer doesn't have a monopoly on prescription ED treatments in the U.S., and sales of Cialis, Cialis for Daily Use, Levitra, and Staxyn will continue to cut into Pfizer's profits. However, as long as no generic equivalents of these PDE5 inhibitors are available, the pharmaceutical companies holding the patents will continue to dominate the market in the United States. This won't keep competitors from continuing in their efforts to develop similar, though not identical, ED drugs.

Safety first: Patients benefit from Viagra patent extension

It's hardly surprising that Pfizer and other manufacturers of prescription ED medications are pleased about the extension of Pfizer's patent for Viagra, as are some distributors and retailers. But where does this action leave patients? Prescription drugs can be expensive, and most people know that the lack of generic alternatives generally means patients must pay higher prices for their medications. Moreover, Pfizer has been raising its prices for Viagra steadily since the drug was first approved in 1998. Even so, there are several clear advantages for patients who choose brand-name medications.

Generic drugs: a cautionary note

Quality control is certainly an issue. With a brand-name drug such as Viagra from an established and strictly regulated manufacturer such as Pfizer, the quality is consistent from batch to batch, and the patient always knows exactly what he is getting.

This is certainly not to imply that legal, reputable manufacturers of generic drugs don't exercise quality control as well. They do. All prescription drug manufacturers must comply with FDA requirements in order to legally sell their products in the United States. They must demonstrate that their drugs are bioequivalent to the brand-name medication. However, bioequivalent does not mean completely identical. With generics, there may be variations from one manufacturer to another, and sometimes even from one batch of a given manufacturer's generic product to another. Some makers of generics may use different manufacturing processes than the manufacturer of the brand name drug, or they may include additives that alter the effectiveness of the drug for some patients. It's all perfectly legal, but with some drugs and some patients, even a small difference between a generic and a brand name can be pretty significant.

Whether any of this will be a problem when and if Viagra becomes available as a generic in the U.S. remains to be seen, but it is a point worth considering. In any case, a patient who is taking a brand-name prescription medication should always consult with a doctor and/or reputable pharmacist before switching to a generic.

Counterfeit drugs are even worse

Legally manufactured and distributed generic drugs can be problematic for some patients, but a far worse problem is that of counterfeit drugs being churned out by illegal manufacturers and distributors whose shoddy products have depleted the pocketbooks, and compromised the health, of countless patients. Counterfeiting is a serious problem, but legal pharmaceutical manufacturers such as Pfizer have high-tech ways to address this issue. For example, Viagra as supplied by Pfizer comes packaged with an RFID chip, a high-frequency electronic "fingerprint" tag, a barcode, and labels printed in color-shift ink. Every bottle sold can be tracked.

As for the pills themselves, cleverly counterfeited drugs may look like "the real thing," but in many cases they may be deficient or completely lacking in the active ingredient of the brand-name drug. Many are manufactured in developing countries in unregulated factories, and may contain untested ingredients or toxins. Moreover - and this cannot be stressed enough - they are illegal, and even if they don't pose health threats they are subject to seizure, and the purchasers may be subject to serious legal action as well. It's really not worth the risk.

Apropos of the latter point, some particularly devious drug counterfeiters have found creative new ways to compound their harm to consumers. As reported in April 2012 by ABC-News' Nightline, some patients purchasing medications from questionable online sources have subsequently been contacted by individuals impersonating Drug Enforcement Agency (DEA) officers. Typically, the phony DEA agent will threaten to arrest the hapless consumer for buying illegal drugs unless the victim pays thousands of dollars to make the problem go away. Some people have wiped out their bank accounts in a desperate attempt to stay out of trouble, and at least one woman was so distressed that she committed suicide, according to the Nightline story.

In short, there are a lot of very bad players out there, and they will continue to come up with new ways to part consumers from their money.

Weighing the true cost

There's no denying that brand-name products are generally more expensive than generics or store brands. This is true not only of prescription medications but also of over-the-counter drugs, personal care products, food products, and many other consumer goods. Sometimes, of course, generic substitutes are perfectly acceptable. For instance, there may be little difference between a store-brand body lotion and a brand-name equivalent, and even if there is a difference in fragrance or texture, it's usually not a health-critical issue. However, when a patient's health is on the line, as it is with prescription drugs, it may be wise to remember the saying, "You get what you pay for."

Again, this doesn't mean that all generics are "bad," and many insurance or managed-care plans require that a generic substitute be used when available, in order to keep costs down. Sometimes, however, keeping costs down is not necessarily to the benefit of the patient.

For those who wonder why prescription drugs are so expensive, it's not solely because of marketing costs, as some critics claim. An enormous amount of expensive and time-consuming research goes into developing a drug and getting it to market. Much of this expenditure is for the protection of the consumer.

The long and winding road to the marketplace

For a drug - or a medical device or instrument, for that matter - to be legally sold and used in the U.S., it must undergo a rigorous testing and approval process. Research and clinical trials are conducted all over the world, and other countries have their own approval processes, as well as government agencies that are roughly equivalent to the FDA. But our focus here is on the United States.

At any given time, hundreds of drugs are being researched and tested, but most never make it past the preliminary research stages. Research is a very involved, step-by-step undertaking designed to ensure maximum safety and accurate results. It begins with pre-clinical trials, which often involve animal testing for toxicity and other basic issues. Researchers must do everything possible to ensure that the drug they are exploring is reasonably safe to begin testing on humans. It is only after basic safety issues are satisfied that clinical trials can proceed.

Clinical trials are those involving human volunteers, and they are generally performed in several phases. Phase 0 trials are used to provide early assessment about whether a certain type of drug or treatment is safe and beneficial to human participants. Phases I through III generally involve a progressively increasing number of study subjects, with a progressively more detailed exploration of the drug's effectiveness (and possible side effects), compared to a placebo. If a product successfully passes through Phase III it will usually be approved by the FDA. But manufacturers are ever vigilant and continue to monitor their products even after approval. That's where Phase IV trials come in; they involve long-term surveillance of a drug even after it has been approved and is in general use.

Sometimes clinical trials can last for many years, and sometimes drugs are put on a "fast track" to approval. Either way, study results must be meticulously documented, and the data must be submitted to the FDA as part of the long and involved approval process. The FDA's own site has an article about that if you are interested

The system is not perfect. Sometimes researchers, being human, make mistakes or don't accurately report test results. Sometimes a drug that passes all of the earlier clinical trials is approved for the market, and later turns out to have unwanted long-term effects. But the important point is that there is a system, one with very well established protocols and regulations, so if a researcher or drug company messes up somewhere along the way, either intentionally or unintentionally, there is accountability. The same simply cannot be said of the illegal imports discussed above. Nor can it even be said about most of the legal but unregulated remedies and supplements and treatments on the market, many of which are ineffective at best, harmful at worst, and sometimes as pricey as some prescription drugs.

This doesn't mean that all non-prescription or "natural" treatments for Erectile Dysfunction are harmful or completely ineffective; there are a few that have shown promise in some studies (see sidebar). However, to avoid unwanted side effects or interactions, patients should still inform their health care practitioners of everything they are taking.

Sticking with "the real deal"

Even the most informed speculation is just that: speculation. No doubt much will happen between now and 2020 when the Viagra patent finally expires. Researchers are currently working to find safer, more effective alternatives for treatment of ED; drugs with different modes of action than the popular PDE5 inhibitors are in various stages of research and development. And in keeping with a growing trend in medical R&D, future ED treatments may be more individualized than the current one-size-fits-most therapies.

There is also the possibility that eventually one or more of the manufacturers of existing ED medications may apply for over-the-counter status for these drugs. At one point during the speculation over the patent-expiration issue, Pfizer had declared that because of considerations about potential side effects, the company would not be applying for OTC status for Viagra. But that could change in the future.

Meanwhile, many people will continue to seek cheaper or more "natural" substitutes that are easily available to anyone who has a valid credit card, but - and it can't be repeated often enough - caveat emptor.

While the world waits for the next generation of ED drugs, men whose doctors have determined that sildenafil citrate is the best option to treat their ED can continue to rely on the blue pill. Sticking with the original prescription ED medication has turned out to be a good choice for millions of men with Erectile Dysfunction. Of course it is also important to obtain medications through a reliable source - either a reputable brick-and-mortar pharmacy or a trustworthy online supplier, such as NetDr.com.