Generic Premphase

No generic versions of Premphase have been approved in the United States. The drug is protected by a patent until January 2015, which prevents manufacturers from making generic versions. Also, Premphase contains a complex estrogen mixture that would be difficult to duplicate. In order for the FDA to approve a generic Premphase, this estrogen component would have to be identical to the brand-name medication.

Generic Premphase: An Overview

Premphase® (conjugated estrogens/cyclic medroxyprogesterone) is a mixture of natural equine (horse) estrogens and medroxyprogesterone, a progestin hormone. It is approved for the following uses in women who still have a uterus (who have not had a hysterectomy):
  • Treating menopausal symptoms, such as hot flashes and vaginal dryness
  • Preventing osteoporosis in postmenopausal women.
Premphase is made by Wyeth Pharmaceuticals, Inc. There are currently no generic versions of Premphase approved in the United States.

Why Isn't Generic Premphase Available?

Generic Premphase is not available for a few different reasons. The patent for the drug is not set to expire until January 2015. This prevents manufacturers from making generic Premphase, unless the patent is challenged.
Also, the estrogen component of Premphase, which is known by the brand name Premarin®, is a complex, natural product. It contains several different estrogens in various amounts. For this reason, it would be difficult to create a generic medication that is exactly like Premphase. The U.S. Food and Drug Administration (FDA) will not approve any generic versions of Premarin (or any medication that contains Premarin, including Premphase) until several requirements are met. Most importantly, the exact composition of the estrogen component must be fully evaluated. This is difficult, because it is not clear which estrogen components of Premphase are really "active" ingredients and which are not. Any potential generics must be shown to be identical to Premphase in terms of the content, dose, and absorption of these active components.
Good Food, Good Bones

Premphase Drug Information

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