Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its abbreviated new drug application for a single‑patient‑use prefilled pen of teriparatide, a bone‑strengthening medication. The approval, granted on December 15 2025, allows the company to market the product under the brand name FORTEO® in the United States, positioning it as a bioequivalent alternative to Eli Lilly’s long‑standing branded product.
The approval gives Amphastar access to a U.S. teriparatide market valued at roughly $585 million for the 12 months ending September 30 2025. The company’s first pen‑device combination product demonstrates its capability to develop complex generic delivery systems, and its U.S.‑based manufacturing plant offers a supply‑chain advantage over competitors that rely on overseas production.
Amphastar’s recent earnings report showed mixed results: revenue grew, but net income fell due to a litigation provision and a licensing payment. The teriparatide approval is part of the company’s broader strategy to shift half of its portfolio to proprietary products by 2026, with BAQSIMI® and Primatene MIST® already driving growth. President and CEO Dr. Jack Zhang said the approval “reinforces our commitment to domestic manufacturing and expands our therapeutic reach in osteoporosis, a high‑need area for patients.”
Investors reacted positively to the approval, with the stock rising in pre‑market trading. Analysts highlighted the approval as a key driver of the market move, noting that it opens a sizable market and signals Amphastar’s ability to bring complex generics to market. The approval also aligns with the company’s narrative of expanding its product mix and improving margin potential through proprietary offerings.
Amphastar plans to launch the teriparatide injection by the end of 2025. The company’s guidance for the next quarter remains unchanged, but management expressed confidence that the new product will strengthen its revenue mix and support the company’s transition toward higher‑margin proprietary drugs. The approval is expected to enhance Amphastar’s competitive positioning against Eli Lilly and other generic entrants while reinforcing its domestic manufacturing strategy.
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