Mylan Pharmaceuticals, the company that earned $1 billion last year for its EpiPen, has helped pass legislation in 48 states to ensure that schools have the device. But its political maneuvering is only one reason the company has, in its own words, become “the number one dispensed epinephrine auto-injector,” according to a report from Kaiser Health News.
High-profile deaths in several states, particularly among school-age children, have helped spur legislative action and fuel demand for consumer-dispensed epinephrine. At the same time, no other company has been able to compete effectively with Mylan’s drug-delivery device. Patent rules and competitors’ manufacturing slip-ups also have helped the company reign over the consumer epinephrine market.
Lobbying is just one way the company has spent hundreds of millions of dollars “developing” the EpiPen since it acquired the patent in 2007, according to Kaiser. The company added lobbyists in 36 states between 2010 and 2014, and spent more than $1.3 million lobbying in 16 states since 2012. Meanwhile, during the past several years, 10 states have passed laws requiring epinephrine in schools, and another 38 states have passed laws permitting them, according to the advocacy group Food Allergy Research & Education (FARE).
EpiPens are at 63,000 schools nationwide, and Mylan has distributed 500,000 of them for free through its EpiPens4Schools program.
New York State’s Attorney General has announced that his office will investigate Mylan to determine whether it introduced “anticompetitive terms” into school contracts.
Mylan also has a virtual monopoly on epinephrine auto-injectors simply because there are almost no other products like it, either branded or generic, according to the Kaiser article.
Mylan has a patent on the drug–device combo until 2025. If companies want to make a generic EpiPen, they have to sue Mylan in court to try to invalidate its exclusive rights on the injector, according to Jacob Sherkow, an associate professor at New York Law School.
Trying to create a generic EpiPen is an expensive and risky endeavor, said Sherkow. Even if a company is successful in court, manufacturing the device, which must be identical, is difficult.
Teva Pharmaceuticals took on these challenges. It sued to invalidate Mylan’s patent in court so that it could make a generic version of EpiPen, and successfully got the green light to do so through a settlement agreement. But Teva has yet to win FDA approval to release the product.
Other companies have tried to make their own versions of the epinephrine injector without attempting to copy the EpiPen. But their efforts haven’t been very successful either, Kaiser says.
Amedra Pharmaceuticals makes Adrenaclick, which has an injector with two caps (EpiPen has only one). But Amedra has limited manufacturing capabilities for the device and a barely visible market share, according to analysts.
Auvi-Q, made by Sanofi, was taken off the market after concerns the device wasn’t dispensing the proper dose of epinephrine.
More epinephrine products will be on the market in 2017. Teva’s generic EpiPen is expected to be reintroduced then, and Mylan will put out its own generic in the coming weeks.
Source: Kaiser Health News; September 8, 2016.