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In the wake of mounting criticism over recent price hikes, the company said the generic version will be distributed by its U.S. subsidiary. It will have a list price of $300 for a two-pack, compared with $608 for the brand-name version. The generic version will be available in both 0.15 milligram (mg) and 0.30 mg strengths, the Associated Press reported.
The auto-injection device, which contains the hormone epinephrine, expires after a year. Since most users need several -- one for home, and one for school or work, for example -- the costs can mount up.
With just one competitor, Mylan has a near monopoly on the device. Now, the company is being accused of price gouging after significantly increasing the EpiPen price in recent years.
The list price for the pack of two was a little more than $100 when Mylan first bought the device in 2007. Most of the increase -- from $265 to more than $600 -- has come in the last three years, The New York Times reported.
Health insurance doesn't necessarily help all people who need EpiPens, because those with high deductibles must pay almost the total price.
Some politicians have called for: Congressional hearings on the escalating pricing, an investigation by the Federal Trade Commission, and action by the U.S. Food and Drug Administration to increase competition by hastening approvals of competitors' products, the AP reported.
EpiPens have been marketed since the 1980s, and some observers have also questioned why Mylan still holds a patent. The patent applies to the device itself, not the active ingredient.
At least two companies are seeking approval to sell a rival brand or generic version of EpiPen in the United States, but none are likely to be available until later next year.
However, the compounding pharmacy Imprimis Pharmaceuticals said it may have a version available for individual patients in a few months. It said it would likely charge about $100 for two injectors, the AP reported.
-- Margaret Farley Steele
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SOURCES: Associated Press; The New York Times