Generic for crestor
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Generic Crestor: Legal Battles and Efficacy Comparisons
Legal Challenges Over Generic Crestor
AstraZeneca has been actively defending its patent for Crestor (rosuvastatin) against multiple generic manufacturers. Companies such as Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun have submitted applications to the US FDA to market generic versions of Crestor. These generics argue that Crestor’s patent (US re-issue 37,314) is either invalid, unenforceable, or not infringed. Despite the expiration of patents for other statins like Merck’s Zocor (simvastatin) and Bristol-Myers Squibb’s Pravachol (pravastatin), Crestor’s patent is set to expire in 2016. This legal battle is crucial for AstraZeneca as Crestor has shown effectiveness in reducing arterial plaque buildup in atherosclerosis, potentially maintaining its market share.
Comparative Efficacy and Safety of Generic Rosuvastatin
A study conducted by the Russian Scientific Medical Society of Internal Medicine compared the efficacy and safety of the generic rosuvastatin compound Akorta with the original Crestor. The randomized crossover study included 60 patients with dyslipidemia over a 14-week treatment phase. The results indicated that both Akorta and Crestor significantly reduced LDL cholesterol levels, with no significant difference between the two in terms of efficacy or safety. Specifically, after the first 7-week treatment period, LDL-C levels decreased by 49.0% in the Akorta group and 52.6% in the Crestor group. After the second period, the reductions were 43.4% for Crestor and 47.2% for Akorta. The study concluded that both compounds are equivalent in correcting dyslipidemia.
Clinical Outcomes and Future Implications
Crestor has been highlighted in several studies for its aggressive lowering of LDL cholesterol levels and potential to increase HDL levels, leading to significant regression of atherosclerosis. The ASTEROID study, for instance, showed promising results using intravascular ultrasound to measure atherosclerosis regression. However, the study lacked a placebo or comparator group, leaving some questions unanswered about the relative efficacy of Crestor compared to other statins or lifestyle changes. Despite these limitations, the findings suggest a potential paradigm shift in the treatment of atherosclerosis, with high-dose statins like Crestor and Lipitor showing the ability to halt or even reverse disease progression.
Conclusion
The ongoing legal battles over generic versions of Crestor highlight the high stakes involved in the pharmaceutical market for statins. Comparative studies indicate that generic rosuvastatin compounds like Akorta are as effective and safe as the original Crestor, potentially offering more accessible treatment options for dyslipidemia. Meanwhile, clinical studies continue to underscore the significant impact of Crestor on atherosclerosis, suggesting a promising future for its use in cardiovascular disease management.
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