Wednesday, April 10, 2013 2:40:22 PM
http://www.project-aware.org/Managing/Hrt/PremarinFacts_Opinion.shtml
Premarin is a patented drug made up of conjugated estrogens obtained from the urine of pregnant mares (PREgnant MARes' urINE, or PMU)
Manufactured exclusively by Wyeth-Ayerst at Ayerst Organics Ltd. In Brandon, Manitoba, Canada, Premarin is Canada's most lucrative pharmaceutical export to date. It is the most widely prescribed drug in the United States and holds 80% of the estrogen supplement market worldwide.
Premarin was first marketed for menopause in 1942. By 1972, Premarin tablets were certified by the FDA as effective for treating menopause, and in 1986, based on studies conducted by Wyeth, the FDA approved Premarin for treatment of osteoporosis.
Premarin has become the drug of choice for hormone replacement therapy in the '90s. Some estimates claim that close to nine million women are currently taking Premarin (about a third of the thirty million plus post menopausal women in the United States are on estrogen replacement therapy, and of them, about 80% use Premarin). Wyeth's revenues from Premarin are currently $1billion a year and rising.
3. IS A GENERIC (LESS EXPENSIVE) VERSION OF PREMARIN AVAILABLE? A generic version of Premarin would save female consumers approximately $300 million a year, not to mention a generic version would not involve horses or harvesting the horse's urine.
Several smaller pharmaceuticals, including Duramed Pharmaceuticals, did develop generic versions of Premarin in the '70s and '80s, as Premarin's patent expired. In 1990, however, Wyeth-Ayerst told the FDA that the generic products on the market released estrogens more quickly into the blood stream than Premarin. Relying on the Waxman-Hatch Act's requirement that a generic have the same rate (how fast the drug enters the blood) and extent (how much total drug enters the blood) of absorption as the listed drug product, Wyeth-Ayerst has (so far) successfully waged a campaign to keep these generics off the market. As a result, although the generics have been developed, none are currently on the market or available to women.
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