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For semaglutide, the earliest realistic timeline for generic injectable entry: 2029: Generic manufacturers begin bioequivalence studies (2 years before the 2031 method-of-use patent expiration) 2030: ANDA submissions filed 2031-2032: FDA approvals granted, market entry Generic oral semaglutide could follow a faster timeline because Teva's Paragraph IV strategy (using a different absorption enhancer) avoids the SNAC patent entirely: 2026: Teva completes bioequivalence studies (already done as of April 2026) 2026: ANDA submission 2027: FDA approval, market entry The gap between patent expiration and market entry is why patients should not expect immediate cost relief when patents expire

Unlike injectable semaglutide, which has undergone extensive testing, sublingual semaglutide's efficacy and long-term safety remain largely unknown

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Weighing risks and benefits of liraglutidethe FDAs review of a new antidiabetic therapy