Amphastar Announces FDA Approval for Teriparatide Injection

RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO.

"We are proud to announce FDA approval of Amphastar's first-ever pen device combination product, demonstrating our continued commitment to advancing innovative approaches for complex drug delivery mechanisms," said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "Our teriparatide drug product is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO, providing patients confidence in its reliability and effectiveness, while offering a thoughtfully designed, easy-to-use, and affordable option for managing daily osteoporosis therapy. Manufactured entirely in-house, with the drug product manufactured at our U.S. facility, we offer a dependable and resilient supply chain. This sets us apart in a market where many competitors rely on overseas production. Overall, we believe this milestone underscores our commitment to domestic innovation, rigorous quality standards, and operational agility, positioning us to capture greater value across our portfolio."

Teriparatide injection is indicated:

• for the treatment of postmenopausal women with osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy;

• to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy, and

• for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.

According to IQVIA, the overall U.S. sales for teriparatide injection were approximately $585 million for the 12 months ended September 30, 2025.

Amphastar plans to launch its teriparatide injection by end of the year.

Pipeline Information

The Company currently has two abbreviated new drug applications ("ANDAs") and one biosimilar insulin filed with the FDA targeting products with a combined market size of over $1.8 billion, along with three biosimilar products in development targeting products with a market size exceeding $6 billion, and two generic products in development targeting products with a market size of over $1 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2025. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.