Mylan to Offer Generic EpiPen

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cheaper generic version of the emergency allergy treatment EpiPen will be made available within the next few weeks, manufacturer Mylan said. 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 Pressreported. EpiPens are used to treat anaphylaxis -- a severe, potentially fatal allergic reaction to insect bites and foods like nuts and eggs.

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. The raging debate over EpiPen pricing has offered a surprisingly wide window into the complicated world of prescription drug pricing, in which powerful drug companies, pharmacy benefit managers, insurers and federal health programs all play major roles. However, the system remains opaque.Last week, the company announced steps to increase the financial assistance for the branded EpiPen, for both commercially insured and uninsured patients. Those measures, however, did not stem the public furor, in part because the company kept the list price the same. So now, the company will essentially sell the same product under two names at two price points, in competition with each other.The new move did not mollify critics, either. Some noted that even at $300, the generic would still be triple the price of the EpiPen in 2007, when Mylan acquired the product and began steadily raising its price. The increases have accelerated in recent years. Even the generic, expected to be available in several weeks, should provide a nice profit to Mylan because its manufacturing costs are believed to be far less than $300.Several consumer advocacy groups, unhappy with Mylan’s handling of the drug’s pricing, said that on Tuesday they would deliver petitions signed by over 600,000 people to the company’s American corporate headquarters in Canonsburg, Pa. In addition, the House Committee on Oversight and Government Reform said that it had started an investigation and had asked the company for information about the product.Robert Weissman, president of the consumer group Public Citizen, said Mylan should just cut the price across the board. “The weirdness of a generic drug company offering a generic version of its own branded but off-patent product is a signal that something is wrong,” he said in a statement. “In short, today’s announcement is just one more convoluted mechanism to avoid plain talk, admit to price gouging and just cut the price of EpiPen.”While brand-name drug companies sometimes start selling so-called authorized generic versions of their own products, it is usually to undercut an outside generic competitor. In this case, Mylan faces no immediate generic threat.