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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
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