Generics
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
14 November 2025 -

US-based based generic pharmaceutical company Ingenus Pharmaceuticals announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its Conjugated Estrogens Tablets, USP, the first FDA-approved generic equivalent to Premarin Tablets, and is launching the product commercially.

Conjugated Estrogens Tablets, USP are offered in all FDA-approved strengths: 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg.

Indicated in the treatment of moderate to severe vasomotor symptoms due to menopause and the prevention of postmenopausal osteoporosis, the product is available to customers nationwide immediately.

Paul Dutra, Ingenus Pharmaceuticals executive vice president, said: "The availability of the first generic version of Premarin Tablets represents a significant step forward in expanding access to this important therapy."

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