Duramed Receives Patent for Tablet Composition of Estrogen/Progestin Product

The US Patent and Trademark Office has granted Duramed Pharmaceuticals Inc. (Cincinnati) a patent for the composition of Cenestin (synthetic conjugated estrogens, A) Tablets and solid oral dose pharmaceutical products containing synthetic conjugated estrogens, A in combination with a progestin. In March, Duramed received FDA approval to market Cenestin, a new plant-derived synthetic conjugated estrogens product for treating moderate-to-severe vasomotor symptoms associated with menopause.

The patent, titled "Pharmaceutical Compositions of Conjugated Estrogens and Methods for Their Use" (5,908,638), provides Duramed with exclusive rights through July 26, 2015, for its novel pharmaceutical compositions and methods for the preparation containing synthetic conjugated estrogens, A for the treatment of vasomotor symptoms.

In December 1998, Duramed filed an IND with the FDA to study the effects of Medroxyprogesterone (a progestin) administered cyclically in combination with Cenestin. The study will evaluate the combined drug product for the treatment of vasomotor symptoms in postmenopausal women with an intact uterus. Duramed expects to initiate the Phase III clinical trials in the coming months.

Duramed Pharmaceuticals develops, manufactures, and markets prescription drug products, focusing on women's health and the hormone replacement therapy market.

For more information: E. Thomas Arington, CEO, Duramed Pharmaceuticals, 7155 E. Kemper Rd., Cincinnati, OH 45249. Tel: 513-731-9900. Fax: 513-731-5270.