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Author: Admin | 2025-04-28
Similar situations have occurred with other generic drugs, like digoxin, isoproterenol, and nitroprusside.10 While lack of competition is the most likely cause of increased prices, shortages of raw materials, a decrease in new generic medications, and FDA regulations are also considered possible contributing factors to the increase in drug prices.8 Although generic drugs have experienced a rise in cost, most are still priced well below drugs that are still available only as brand-name products. Though the FDA approved a record-breaking number of ANDAs in 2016 and the median time for a brand drug to hold a patent is 12.5 years, drug manufacturers have found ways to extend the life of a patent.3,11 Manufacturers refer to this as product life-cycle management. This involves trying to prevent generic competition and maintain drug exclusivity. Brand-drug manufacturers can achieve this by obtaining additional patents on other aspects of a drug.12,13 Therefore, it is difficult to accurately predict when a generic equivalent will be marketed. Table 1 lists first generics released in the U.S. at the end of 2016, and the predicted first generics for 2017. This article will briefly discuss these new generic medications. Cardiovascular Agents Zetia (ezetimibe): Ezetimibe, the generic equivalent for Zetia (ezetimibe), was released at the end of 2016. Ezetimibe is an antilipemic agent used in the treatment of hyperlipidemia. Even though statins are considered first-line treatment of hyperlipidemia, ezetimibe is commonly used in combination with statins. When used in combination, ezetimibe works to inhibit cholesterol absorption and can help reduce the dose of the statin by 12% to 20%. While it seems as though ezetimibe is efficacious, studies have shown that ezetimibe does not affect surrogate endpoints.14 Vytorin (ezetimibe-simvastatin): The generic equivalent for Vytorin (ezetimibe-simvastatin) was released earlier this year. It has taken this generic longer than expected to enter
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