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Sanofi has agreed a deal with Lilly to license its erectile dysfunction drug Cialis and sanofi cialis 2017 pursue approval for non-prescription use. Under the terms of sanofi cialis 2017 the deal, Sanofi's consumer health division has acquired exclusive rights to apply for approval of an over-the-counter (OTC) version. Cialis (tadalafil) in the US, Europe, Canada and Australia and then to sell the drug in these regions once its patents expire. The drug is currently marketed by Lilly and is only available legally via prescription once a doctor has diagnosed erectile dysfunction in a man. It has been available in Europe since 2002 and in the US since 2003 in this form, recording total global sales of 14bn (10.2bn) in that time despite competition from the likes of Pfizer's Viagra (sildenafil). Cialis is set to lose patent protection in 2017, however, opening the market to competition from much cheaper generic rivals, as has happened with Viagra. Despite extending the drug's US exclusivity to 2020, Pfizer faced patent losses in the rest of the world last year, leading to a dramatic fall in global sales for the product. Lilly faces a similar fate with Cialis and has made the deal with Sanofi financial terms of which were undisclosed - to maximise the drug's potential. If approved in an OTC indication it would be the first former prescription erectile dysfunction drug available directly to consumers, giving it a huge advantage over Viagra and Bayer's Levitra (vardenafil which also faces generic competition. Pfizer has previously tried to make an OTC switch for Viagra, but withdrew from these efforts in 2008 after regulators raised concerns about the drugs' safety profile in men with underlying conditions such as heart disease. Lilly and Sanofi will be hoping the process is smoother for Cialis despite the likelihood of coming up against similar safety issues. David Ricks, senior VP at Lilly and president of Lilly Bio-Medicines, said: sanofi cialis 2017 "Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately."). Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their sanofi cialis 2017 erectile dysfunction (ED but they may not be the only ones facing dysfunctionalities. . As the patents on these lucrative lifestyle drugs come to an end, price tags and bottom lines are expected to plummet. PDE5 Inhibitors, viagra made by Pfizer and Cialis by Eli Lilly are phosphodiesterase type 5 (PDE5) inhibitors which break down cyclic guanosine monophosphate (cGMP). . In a gross simplification, after sexual stimulation, an erection occurs through the release of nitric oxide (NO) which causes dilation of blood vessels due to an accumulation of (cGMP). . Dysfunction occurs when cGMP conflicts with the NO vasodilatory effects. When the PDE5 inhibitor is introduced, the cGMP is broken down. . So, less cGMP means more blood flow et voil, an erection. There are differences between these drugs, though. . For example, Viagra is made with sildenafil and has a wait time of 30-60 minutes lasting for up to 4 hours. Cialis main ingredient is tadalafil and can either be taken daily (meaning it is always active in the body) or 30 minutes to 12 hours before activity to last up to 36 hours. This longer lasting formula is one of the benefits over the little blue pill which has proved to be more appealing to most men. . Further, sildenafil and tadalafil have different chemical and molecular structures. Viagra and Cialis Patent Protection, the success of these drugs has been guaranteed in large part by securing IP rights across the globe. . Viagra was approved by the FDA in the United States in 1998 and Cialis in 2003, but their patent journeys occurred earlier. The first patent for Viagra was filed in May 1994and was issued in 2002, but Viagra did not begin as an ED pill. The compound was originally developed and patented as a drug called. Revatio to treat high blood pressure (hypertension) and chest pain due to heart disease (angina pectoris but clinical trials showed that it was more effective at inducing erections than anything else. The drug was then renamed and patented as Viagra. Viagra was a pre-gatt application because it was filed before June 8, 1995, so it got the benefit of choosing its expiration date: either 17 years from the issue date of 2002, that is to say October sanofi cialis 2017 2019 or 20 years from filing, with rights. Naturally, Pfizer selected the later October 2019 date. . Further, through the FDA, the expiration was extended another 6 months to April 2020 due to a special pediatric exclusivity testing, revatio s effect on pulmonary arterial hypertension. With the expiration of Viagra three years away, you would think that the market for generics would be on hold until then. . However, an Israeli manufacturer named Teva Pharmaceutical Industries Ltd. Will be allowed to sell a generic version of Viagra beginning December 11, 2017. Since several patents outside the US have already expired, an undisclosed deal was arranged after Pfizer sued Teva and Teva was authorized sanofi cialis 2017 to launch a generic version. . The settlement stipulates that the generic manufacturer will have to pay royalties to Pfizer through the April 2020 patent expiration date. Tevas inventory has already been approved by the FDA for three different strengths of sildenafil citrate and the company has been selling a generic in the European Union since 2013.

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