jueves, 27 de junio de 2013

Al filo de lo posible: Caducidad de los "filos" (USA)

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 . 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. (Más)

Ver también:

PFIZER: TEVA te va a dar duro con su genérico de Viagra...

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