The Impact of expiring Viagra patents on consumers

Pfizer is the pharmaceutical corporate giant behind Viagra, the globally popular and successful erectile dysfunction medication, which has earned Pfizer billions of dollars since it was first marketed in 1998. Over the last 13 years Pfizer has enjoyed legal protection from copycat generic drugs thanks to patents on Viagra and its active ingredient Sildenafil, which have kept competition low and prices for Viagra high.

Now Pfizer’s patents are starting to expire. Its Brazilian patent expired in June 2010 and the patent for New Zealand expired this month, whilst the US patent will expire in March 2012 (pending a trial). The sales figures of Viagra are expected to take a hit as increased competition from generic versions of the drug legally enter the market but what will be the impact on the consumer?

The first obvious answer is that falling prices is a good thing for the consumer. The high price of Viagra and other erectile dysfunction drugs, such as Cialis and Levitra, has meant that access to drugs for a condition that affects 1 in 10 men worldwide has been limited to those who can afford it. A significant drop in the price will bring it within financial reach for many more men.

However, in New Zealand Dr Bert Rauber has raised concern that cheaper anti-impotence medication may have an adverse effect on health. He is concerned that lower prices will cause increased demand and put pressure on GPs to prescribe the cheaper medicines without first conducting testing for potential underlying causes.

“The concern is that if more are asking for it they won’t look at the bigger picture.”  States Dr Rauber, who runs an erectile dysfunction clinic in Hamilton. The bigger picture being that erectile dysfunction is often viewed as an early warning sign of deeper underlying medication conditions, such as diabetes, prostate cancer and heart disease. If it becomes cheaper for doctors to prescribe erectile dysfunction medication then it is possible that the testing for these diseases and the subsequent necessary treatment maybe delayed or missed altogether.

In New Zealand Auckland-based Douglas Pharmaceuticals has already released a cheap generic drug, while Pfizer has offered its own generic, ‘Avigra’.  According to Dr Rauber the price has dropped from $25 to $8 a tablet. The relative affordability may result in more men seeing it as a lifestyle drug with which to improve their sexual prowess in the bedroom rather than because they have genuine erectile dysfunction.

“Now it’s cheaper, there’s going to be a lot of guys running around saying `I want a harder erection’, but they don’t actually have any erectile dysfunction. They have, in their own mind, a poor erection, but it’s subjective isn’t it?” says Dr Rauber.

New erectile dysfunction medication awaiting FDA approval

Vivus Inc. have announced that they have submitted a “New Drug Application” (NDA) to the US Food and Drug Administration (FDA), for a new medication to be entered into the lucrative $4 billion erectile dysfunction market.  The new drug, named “Avanafil”, may take several months for its FDA approval to be confirmed and will be thrust into an increasingly competitive market that already includes Viagra, Cialis, and the newly introduced Levitra Orodispersible tablets.

Clinical trials with Avanafil have taken place involving over 1,350 subjects, with 50mg, 100mg, and 200mg dosage strengths being analysed. The NDA submitted by Vivus is backed up by including data from Phase 3 trials and these trials were said to have proved the drug’s safety and efficacy. Results showed that patients who had taken the 200mg dose, had achieved an erection sufficient for penetration in 77% and 63% of the trials, in comparison to just 54% and 42% in patients dosed placebo. In addition, many patients were able to have successful intercourse in a mere 15 minutes of taking Avanafil.

With the patent for Viagra due to expire in 2012, the market for impotence medication will become very interesting in the following year and we may yet see many more new and exciting products being introduced.

Pfizer files suit to protect Viagra patent

The 1 June 2011 saw Pfizer file suit against Watson Pharmaceuticals Inc. in the United States District Court for the Southern District of New York in an attempt to prevent Watson commercializing its generic Viagra drug. This legal action could well be the first of many for Pfizer as its patents on Viagra expire between 2011-2013.

It is expected that generic drug manufacturers will make legal moves to end the Viagra patent before its deadline is up. Companies could either sue Pfizer claiming its patent is invalid or file with the Food and Drug Administration (FDA) to launch generics ahead of the deadline. Watson Pharmaceuticals have done the latter, seeking approval to market Sildenefil Citrate Tablets, a generic version of Pfizer’s Viagra.

It is understandable why generic manufacturers may attempt to knock even a few months off the patent. Viagra had a total U.S. sales of just over $1 billion for the twelve months ending April 2011. Even one month’s sales are worth $83 million. Equally so, it is understandable why Pfizer will be willing spend millions of dollars in legal fees to protect the patent.

In the long run, the expiration of Pfizer’s monopoly on Viagra will be good news for consumers, as it will result in competition between Pfizer’s Viagra and new generic versions, driving down the price of erectile dysfunction medication.