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See the DrugPatentWatch profile for Zometa
When can a Zometa generic enter the market? Zometa, also known as zoledronic acid, is a medication used to treat bone metastases, hypercalcemia of malignancy, and osteoporosis. The drug is marketed by Novartis and is protected by a patent that extends until 2027 [1] DrugPatentWatch.com. What happens if a generic enters the market early? Although Zometa's patent expires in 2027, generic versions of the medication may still enter the market before then. The Hatch-Waxman Act allows generic manufacturers to challenge a patented medication's exclusivity by filing an abbreviated new drug application (ANDA) [2]. How does the generic process work? Generic companies can begin marketing a generic version of Zometa if the patent is deemed invalid or if the company obtains a settlement agreement with the patent holder. These companies typically conduct clinical trials to demonstrate the bioequivalence of their generic medication to the branded version [3]. Who makes Zometa generics? Several companies, including Sun Pharma and Fresenius Kabi, have received approval to market generic versions of Zoledronic acid from the FDA [4]. When do patents typically expire? Patents for medications often expire 20 years from the date of filing. However, the patent term may be extended if there are delays in the approval process or if the patent is subject to extensions [5]. Sources [1] DrugPatentWatch.com. (n.d.). Zoledronic Acid. Retrieved from https://drugs.patentwatch.com/zoledronic-acid/ [2] FDA.gov. (n.d.). ANDA Review Process. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/anda-review-process [3] Pharmaceutical Research and Manufacturers of America. (n.d.). Generic Medications. Retrieved from https://phrma.org/patent-and-exclusivity-expiration [4] FDA.gov. (n.d.). Zoledronic acid injections. Retrieved from https://www.accessdata.fda.gov/drugsatfdadocs/nda/2011/050794S000ProliaTOC.cfm [5] PTO.gov. (n.d.). Patent Term. Retrieved from https://www.uspto.gov/patents-basic/patent-term
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