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    (RTTNews) - The process of drug development is costly and time consuming. It takes 10 to 15 years, and costs a pharmaceutical company millions to develop and win approval for a new drug. The cost of drug development is $2.6 billion, according to a 2016 report by Tufts Center for the Study of Drug Development. A company can apply for patent anywhere along the development lifeline of a drug, and the patent term of a drug runs for 20 years from the date of filing. According to the America Invents Act (AIA), signed into law by President Barack Obama on September 16, 2011, the first to file the patent application, regardless of the date of invention, is granted the patent. This is a shift from the previous "first-to-invent" patent system. S., manufacturers of pharmaceutical drugs have the rights to set their own prices for the new drug they develop, in this case, what is called a branded drug, and the on-patent period gives the companies the most advantageous marketing edge. But the expiry of patents on branded drugs will throw the gate open for competition from relatively inexpensive generic drugs. The generic competition will reduce pricing/market share of the branded drug by more than 80% in less than 12 to 18 months. buy kamagra jelly online uk On one level, if a brand name drug loses patent protection, that often marks the date when companies can begin marketing generic versions of the drug. S., hoping that tribal sovereignty would protect the patents, but the courts struck it down. Lilly’s Cialis is prescribed for erectile dysfunction—that’s the one whose advertising campaign has a man and a woman in separate bathtubs outdoors. However, this has grown more complicated with the approvals of biosimilars. Lyrica’s patent ends in December, although Pfizer is working to get an extension for pediatric exclusivity. No generics have won approval yet, however, although Akorn, Mylan, Teva and Pfizer’s Innopharma have generic applications pending. Biosimilars are essentially generic versions of biologic drugs, but the difference is they are “similar” rather than the same drug. Food and Drug Administration (FDA) rejected Mylan’s biosimilar in October 2017, although it was related to manufacturing issues with Mylan’s partner, Bio Con. Other companies working on generics of Neulasta include Coherus, Pfenex and Pfizer, with biosimilars hitting the market by the end of this year. If they get it, it will only push competition down the road six months or so. The drug actually lost patent protection in 2010, but companies haven’t come up with copycats because the product uses the Diskus inhaler, which is difficult to copy. The most likely to come up with a biosimilar is Pfizer. As a result, there is a more complicated approval process, which can add months and sometimes years to the biosimilar launch. The drug is prescribed for blood cancers and rheumatoid arthritis. Analysts are expecting biosimilars to launch in the middle of this year, probably in the third quarter. Neulasta is used to increase white blood cells in patients undergoing chemotherapy. Mylan and Sandoz are likely to come out with biosimilars. The drug was approved in 2004 and is used to treat nerve and muscle pain. Prescribed for asthma and chronic obstructive pulmonary disease (COPD), Advair brought in $2.23 billion in U. It’s so difficult to copy, in fact, that the FDA set up special guidelines for generic approvals, but companies are still having difficulties meeting their guidance. Sandoz has a biosimilar in Europe, but no longer appears to be developing it for the U. And some biopharma companies have negotiated longer timelines with their biosimilar competitors, and patent battles are common. Several companies are planning biosimilars, including Pfizer, Mylan and Amgen. Last year it brought in $3.46 billion, but it’s been a blockbuster for almost 14 years and the loss of patent protection is a big loss for the company. Some companies, such as Teva Pharmaceuticals, have given up completely. All of which is a way of saying that although these 15 drugs’ patents expire in 2018, their generic or biosimilar competitors may not necessarily hit the market this year. Others that have been rejected include Mylan, a group from Hikma-Vectura, and Sandoz. Prescribed for allergic asthma and chronic idiopathic urticaria, Xolair loses a key patent this year, although at this time it’s not clear if there are any pending biosimilars on the near horizon. Biosimilars have been on the market in Europe for about a decade, but the U. biosimilars market lags behind Europe significantly. As a result, it’s not really clear when there will be generic competition, although many think Mylan will come up with something in the next year or so. Glenmark and Sorrento are working on it, but neither have filed with the FDA. As a treatment for anemia, the drug brought in $1.77 billion in the U.

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    Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their 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. Viagra made by Pfizer and Cialis by Eli Lilly are phosphodiesterase type 5 (PDE5) inhibitors which break down cyclic guanosine monophosphate (c GMP). 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 (c GMP). Dysfunction occurs when c GMP conflicts with the NO vasodilatory effects. When the PDE5 inhibitor is introduced, the c GMP is broken down. So, less c GMP means more blood flow et voilà, an erection. For example, Viagra is made with sildenafil and has a wait time of 30-60 minutes lasting for up to 4 hours. Said on Wednesday that as part of a settlement with generic companies over its Cialis patent, the exclusive patent is now expected to end on September 27, 2018 at the earliest, roughly a year-and-a-half earlier than the patent was going to expire. The settlement won't affect 2017 financial guidance or mid-term expectations through the rest of the decade, the company said. The dispute centered around a patent on the unit dose of the drug. Eli Lilly defended the disputed patent as "valid" but said that "this is a royalty-bearing license agreement that provides us with more certainty regarding our U. exclusivity," according to Michael Harrington, the company's senior vice president and general counsel. Cialis treats erectile dysfunction, but the drug -- tadalfil -- is also sold under the name Adcirca for pulmonary arterial hypertension. Adcirca's patent is still expected to expire on November 21, 2017 or, if the Food and Drug Administration grants the company pediatric exclusivity, on May 21, 2018, Eli Lilly said. Eli Lilly shares rose 1.8% to $83.80 in morning trade.

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