January 8, 2016
Patent Problems. While Crestor’s patent is set to expire in the US in 2016, AstraZeneca is already losing sales to generic products in other markets. For example, in Canada a generic version of the statin launched in 2012 and made by Apotex had a negative impact on 2013 figures. AstraZeneca API plant set to shut by 2017 as Patent Cliff strikes again. By Dan Stanton+ Dan Stanton, 18-Dec-2014. An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor. http://www.in-pharmatechnologist .... A A. AstraZeneca has filed patent infringement suits against seven companies that submitted abbreviated new drug applications (ANDAs) seeking to market generic versions of its cholesterol drug Crestor before the patents expire.  AstraZeneca won some important breathing space after defending its cholesterol-lowering blockbuster Crestor from a patent challenge in the US. Actavis (formerly Watson Pharma) filed for approval of generic versions of AstraZeneca's product based on rosuvastatin calcium and rosuvastatin zinc and as a result of the settlement will now be able to sell its products on an exclusive basis in the US between May 2 and July 8, 2016. The first patent for Crestor currently expires in January 2016. This is the earliest possible date that a generic version could become available. However, there are other circumstances that could come up to extend the exclusivity period of the medication beyond 2016. This could include such things as other patents for specific Crestor uses or lawsuits. Once the patent expires, there may be several companies that will manufacture a generic Crestor drug (Page 1 of 1). Actavis said today it is planning a 2016 launch for its generic versions of AstraZeneca’s cholesterol treatment rosuvastatin calcium (Crestor®) 5, 10, 20, and 40 mg tablets, after settling outstanding patent litigation with the pharma giant. As for generic Crestor, its launch date may be earlier and the fee eliminated under certain circumstances, Actavis said. The launch date will ultimately hinge on Actavis receiving final approval from FDA on its Abbreviated New Drug Application (ANDA) for generic Crestor. Rosuvastatin (marketed by AstraZeneca as Crestor) 10 mg tablets. Rosuvastatin, marketed as Crestor, is a member of the drug class of statins, used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease. It was developed by Shionogi.  For many patients, it will likely come down to money: the blockbuster drug Lipitor is about to go generic. Brand-name statins can cost patients some $160 a month. But after the patent on Lipitor expires on Nov. 30, the availability of generic versions could drop its price by 80%. The patent on Crestor — which goes for about $5 a pill — won’t expire until 2016. “The market for Crestor will go close to zero,” Dr. Cam Patterson, chief of cardiology at the University of North Carolina-Chapel Hill, predicted in an interview with USA Today. Lipitor (atorvastatin) and Crestor (rosuvastatin) both effectively cleared away about 1% of artery-clogging plaque in heart patients after two years. Both drugs also lowered LDL, or “bad” cholesterol, and raised patients’ good HDL levels. Actavis, the world's third-largest generics prescription drug manufacturer, said it will launch generic Crestor 67 days before the July 8, 2016, expiration of the drug’s pediatric exclusivity. The drug’s substance patent expires six months earlier. As for generic Crestor, its launch date may be earlier and the fee eliminated under certain circumstances, Actavis said. The launch date will ultimately hinge on Actavis receiving final approval from FDA on its Abbreviated New Drug Application (ANDA) for generic Crestor. The substance patent for Crestor expires on January 8, 2016, but AstraZeneca won a six-month extension under the US paediatric trials incentive programme. Sales of Actavis' generic before the extension expires on July 8 will incur a 39 per cent royalty fee to AstraZeneca. Actavis (formerly Watson Pharma) filed for approval of generic versions of AstraZeneca's product based on rosuvastatin calcium and rosuvastatin zinc and as a result of the settlement will now be able to sell its products on an exclusive basis in the US between May 2 and July 8, 2016. 2013 sales of AstraZeneca’s cardiovascular drug Crestor (rosuvastatin) decreased 8% on the previous year to $5.6bn due to erosion from patent expiration in certain markets. AstraZeneca API plant set to shut by 2017 as Patent Cliff strikes again. By Dan Stanton+ Dan Stanton, 18-Dec-2014. An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor. http://www.in-pharmatechnologist ....
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crestor patent expiration