Ingenus Pharma launches first FDA-approved generic version of Premarin

Conjugated Estrogens Tablets are indicated for moderate to severe menopausal symptoms, including hot flashes, and for the prevention of postmenopausal osteoporosis in women at significant risk

Ingenus Pharmaceuticals has announced a major breakthrough in women’s health, with the FDA approving the company’s Conjugated Estrogens Tablets, USP—the first generic equivalent to Premarin.

The product is available immediately across the US in all FDA-approved strengths: 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, as per the company.

“This launch marks a significant step forward in expanding access to a vital therapy,” said Paul Dutra, Executive Vice President at Ingenus. “We are proud to deliver high-quality, affordable medicines to patients who need them.” The rollout represents a key milestone in Ingenus’ growing women’s health and complex generics portfolio.

Conjugated Estrogens Tablets are indicated for moderate to severe menopausal symptoms, including hot flashes, and for the prevention of postmenopausal osteoporosis in women at significant risk.

However, the therapy carries important safety considerations. Estrogen use increases the risk of endometrial cancer in women with a uterus unless combined with a progestin.

The Women’s Health Initiative (WHI) studies also identified elevated risks of stroke, blood clots, heart attack, and certain cancers with estrogen therapy, particularly when combined with progestins. Estrogens should not be used for cardiovascular disease or dementia prevention and should be prescribed at the lowest effective dose for the shortest duration necessary.

Despite these risks, experts emphasize that the availability of a generic alternative can make this critical therapy more accessible for millions of women.

Ingenus’ new generic aims to provide the same efficacy as Premarin, offering patients and prescribers a more affordable option without compromising on quality.