Xiromed, the generic division of Insud Pharmaceuticals, is debuting estradiol transdermal gel 0.1%, the generic of Divigel.
The company is eligible for 180 days of CGT market exclusivity as the first generic approval to Divigel.
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Estradiol transdermal gel 0.1% is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
Divigel had a market value of $45.8 million for the 12-month period ending July 2022, according to IQVIA.
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“We are excited to offer the first generic estradiol transdermal gel 0.1% to patients in the United States,” said Rob Spina, CEO of Xiromed. “This launch demonstrates Xiromed’s commitment to providing quality, affordable generic healthcare products to patients. Xiromed has established itself as a leading player in generic hormonal pharmaceuticals with a dedicated focus on women’s health care and this launch further bolsters our broad portfolio of women’s healthcare products.”