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Generic Viagra: just around the corner.

There is no doubt the introduction of Viagra in March 1998 not only changed the treatment of erection problems (erectile dysfunction, or ED) for men with spinal-cord injury (SCI) but also created a revolution in the whole sexual realm. Although we didn't realize it initially, this was a sexual revolution in the making. Perhaps for the first time, individuals and couples started talking openly about erection problems and sexual difficulties.

Since that time, media advertising about sexual conditions has become as commonplace as any other form of advertising. Today, much of the shame and embarrassment about sexual problems has slowly begun to disappear for many people. It's now not unusual for individuals to seek professional help for sexual-related issues.

Unfortunately, however, the introduction of Viagra hasn't been such a welcome relief for many men with erection problems. The reality is that most insurances don't pay for Viagra, and the cost is so high a significant number of men simply cannot afford it. Truthfully, most men are not in a position to open their wallet and put out upwards of $20 each time they wish to be sexually active. Regardless of how effective the pill is for men, it's just not practical or affordable.

Online Dangers

Many men have turned to the Internet as one solution to high prices. Buying drugs, such as Viagra, online can be dangerous and a waste of money. A recent article in the International Journal of Clinical Practice reported 44% of Internet Viagra was fake. In addition, buying online products for erection problems poses significant risks by bypassing doctors. Also, there have been reports of potentially dangerous materials often found in the pills.

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For example, one study completed in the Netherlands showed that only 10% of Viagra samples were genuine. As unbelievable as it sounds, the study found all forms of unsafe materials contained in the pills. These researchers pointed out that many erection medications sold online contain ingredients such as shoe polish, printer ink, hair, and caffeine.

Although these medications are often sold as "Canadian products," in reality they are often produced in countries such as China and India that have little if any governmental oversight. So great is the problem of dangerous counterfeit medications that the World Health Organization (WHO) is stepping forward to tackle this problem head on.

End of the Monopoly

Soon, however, turning to the Internet for affordable erection medications will not be necessary. On March 27, 2012, Pfizer will lose its patent for Viagra, according to the U.S. Patent and Trademark Office. When this occurs, any drug company will be able to make and sell a cheap generic version of this blockbuster erection medication.

Doctors and lawyers believe the expiration of Pfizer's monopoly on Viagra will be good news for patients. They believe it will force competition between Pfizer's Viagra and the new generic versions. This should drive down not only the price of Viagra but also of Eli Lilly's Cialis and Bayer's Levitra.

Currently, Viagra, Cialis, and Levitra are the only ED medications allowed by the Food and Drug Administration (FDA) in the United States. Viagra, as the oldest of these three, will lose its monopoly first. (Levitra expires in 2018, and Cialis between 2017 and 2020). Holding on to these patents has been incredibly profitable for these drug companies. To date, Pfizer has raised the price of Viagra 5-11% every year so the current price of Viagra is $14 per pill at the wholesale level.

Future Options

Once the Pfizer patent on Viagra expires, the floodgates will open and consumers will likely be bombarded with advertising for cheap generic sildenafil citrate, the active ingredient in Viagra. Although other companies will not be able to use the name Viagra, they will most likely use similar names consumers will recognize.

No one is quite sure yet how Pfizer will defend its multi-billion-dollar investment. You can be sure a legal fight will be in the works. This year alone, Viagra sales are expected to top $1.9 billion. As a result, consumers can expect to see the company spend millions of dollars in fighting back the legal challenges from other pharmaceutical companies.

One choice will be for Pfizer to continue to make and market the "real thing." In this approach, Pfizer can benefit over the worries regarding generic brands and from fears that the generics will have inferior ingredients. Pfizer can reassure consumers with the name "Viagra" and with packaging that has barcodes, fingerprint tags, and color-shifting ink.

This approach of "staying the course" is a ploy at marketing Viagra as the original ED pill. With more than 25 million men who have used Viagra, Pfizer is gambling many men will not want to switch to a more generic brand. Men want a pill that is reliable and will work every time. No man wants to gamble whether the pill will be effective when they need it the most. Pfizer knows this and will exploit it to their full advantage.

Other options for Pfizer include applying for "over the counter" status for Viagra from FDA. In this approach, consumers would need approval from a pharmacist, but the medication could be obtained without a prescription. Currently, this method is used to obtain Viagra in the United Kingdom. It's a future possibility in the United States as well.

A final alternative might be to license the original recipe of Viagra to other companies while producing an "upgraded" version with a new patent. Some people believe this "updated" product might have a time-release formulation similar to Cialis or be administered in the form of a topical ointment.

Ready to Cash In

Regardless of what approach Pfizer ultimately decides, it appears generic Viagra may be debuting in spring 2012. Each month that passes after the expiration of the Pfizer patent means the loss of millions of dollars for other companies. Numerous pharmaceutical firms are just waiting to jump on the ED bandwagon and cash in on the flood of profits to be made.

Hopefully the expected competition and introduction of generic Viagra will prove to be a huge advantage for the majority of men with SCI who also have ED. Until now, many of these men and their partners have not been able to afford and benefit from that little blue pill. With a bit of luck, that is about to change.

Contact: ducharme@bu.edu.

Want specific information? Send an e-mail to Ducharme. The topic may apply to many PN readers and could be the subject of a future column. All inquiries are confidential.
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Title Annotation:intimacyissues
Author:Ducharme, Stanley
Publication:PN - Paraplegia News
Date:Nov 1, 2011
Words:1093
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