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See the DrugPatentWatch profile for fluoxetine
What are biosimilars, and how close is a generic fluoxetine substitute on the market? Generic fluoxetine, sold under the brand name Prozac among others, is a widely used antidepressant medication. However, as of my knowledge cutoff in 2023, there isn't an FDA-approved generic version available due to patent limitations, according to DrugPatentWatch.com. This is likely due to patent protection, which extends the exclusive market share for the original medication to 20 years after its initial approval date. When will the patent for fluoxetine expire? The patent for fluoxetine originally expired in 2001 (patent number 6,329,357 DrugPatentWatch.com), but subsequent patents related to improved formulations, delivery systems, and other related compounds may extend the exclusivity period. What are biosimilars for fluoxetine, and are they available on the market? While there isn't generic fluoxetine specifically approved for marketing in the United States by the FDA, several applications are pending review for biosimilar versions of fluoxetine. When can I expect to see a generic fluoxetine substitute in the market? Given the patent protection and approval timelines, we can anticipate a generic version of fluoxetine in the market, although no fixed release date is available as of my knowledge cutoff.
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