The generic form of Lotrel is Amlodipine Besylate/Benazapril HCl. According to the FDA website, there are still two unexpired patents on this drug. The first expires on March 25, 2007. The second, which is a "use" patent expires in 2017. At least two companies have "tentative" approval, which means that they have satisfied everything except the innovator is still enjoying some patent protection. Most likely, the generic will launch this year. The 2017 patent is most likely a new use discovered after initial approval. The generic companies have most likely filed a statement in their application that indicates that they will not infringe on this new use. The labeling for the generic will not include that use on it, and they cannot advertise for it. In reality, this makes little different to the patient, because there is no difference in the drug, only the labeling is different. Most likely, unless they generics have been sued by the brand for patent infringement, the generics will launch this month.
Another issue that gives some uncertainty is that Amlodipine is on a list generated by the FDA in which the FDA is requesting that companies perform studies in pediatric patients. If a company performs and submits studies, and they are acceptable to FDA, they will recieve another 6 months exclusivity, so the patent might be extended to 9/25/07.
2007-03-09 07:34:46
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answer #1
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answered by leoccleo 3
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I can not vouch for how valid this site is (looks legitimate), but the site states the patent runs out in 2007. They correctly state that the first step is for the patent to expire, and they note that often the drug companies fight this so they can maximize their profits.
Since Lotrel is a combination of two older medications it should not be difficult for them to develop a generic form.
2007-03-07 06:01:25
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answer #2
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answered by tickdhero 4
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You should read "The Blood Pressure Solution" (also available in electronic format, watch the video presentation here: http://www.fixbloodpressure.com ) It's a very comprehensive step-by-step book that walks you through the natural remedies of high blood pressure. It provides you with a lot of information on what foods to eat, how you can acquire and prepare these foods, how you can change your lifestyle for the better, how to eliminate the toxins from your body, how to reduce stress, how you can check your blood pressure level the correct way etc.
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2014-07-19 07:34:04
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answer #3
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answered by Anonymous
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i've got under no circumstances heard of any variety of courting between bp meds and diabetes. i do no longer think of there are any "organic meds" that effectively decrease bp. stress alleviation, exercising, weight administration, no nicotine, rest concepts are all the type to diminish bp. yet whether one faithfully implements a number of those, meds nevertheless may be required, tho in decrease doses.
2016-09-30 08:08:50
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answer #4
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answered by ? 4
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