The FDA approved a generic version of Eliquis, but it won’t be available for several years

Drug Patents and Renewals
Published: Jan. 13, 2023 at 7:19 PM EST
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GREENVILLE, S.C. (FOX Carolina) - William Hughes has owned complete automotive repair in Laurens for 25 years. He often works long hours. But all this work sometimes isn’t enough to pay the bills. He and his wife deferred their mortgage to pay for medical expenses.

“It’s hard to make it sometimes,” Hughes said. “We were glad our mortgage allowed us to defer for a time period.”

One drug that costs him a lot every month is a blood thinner drug known as Eliquis. It is used to treat blood clots and prevents him from having a stroke. The out-of-pocket cost is around $600 a month. He says with his insurance he pays about $100 a month.

“It’s really high,” Hughes said. “It’s expensive and I can’t imagine paying for it if I didn’t have insurance.”

He thought there could be some relief on the horizon. In 2019 the FDA approved a generic version of the drug. That’s because according to government documents the composition of the matter patent covering apixaban or Eliquis was set to expire in February 2023.

Fowler’s pharmacy manager David Maney says that could have dramatically decreased the cost of the drug. He estimates instead of $600 a month the cost would be around $12 a month.

But the generic version of the drug won’t be available for several more years. Bristol Myers Squibb and Pfizer fought to restore their patent. They sent Fox Carolina a statement. This is a portion of that statement.

“A significant portion of a product’s patent life is lost during the time it takes an innovative company to develop and obtain regulatory approval of a new drug. As compensation at least in part for the lost patent term due to regulatory review periods, the innovator may, depending on a number of factors, apply to the government to restore lost patent term by extending the expiration date of one patent up to a maximum term of five years, provided that the extension cannot cause the patent to be in effect for more than 14 years from the date of drug approval.”

A court ruling granted that extension and now a generic will not be available for sale until April 2028. Patent extension or restoration is a common tactic pharmaceutical companies use to hold onto revenue for their products. According to one study in the Journal of Law and Biosciences of about 100 best-selling drugs more than 70% had their protection extended at least once.

“I think the pharmaceutical companies have made enough off of it and they should let it go generic,” Hughes said. “Hopefully our lawmakers can put their foot down and make this stop.”

Eliquis has been on the market for about 10 years. According to Bristol Myers Squibb’s third quarter financial report Eliquis was their top revenue generating drug so far in 2022.

Hughes is a businessman too and understands the importance of generating revenue to stay afloat.

“If a pharmaceutical representative came into my shop I would give him a fair price just like everyone else,” Hughes said. “Just why, why are pharmaceutical prices so high? And why do they prevent them from going generic for so long?”