Lawsuits preventing generics from making it to market
Roughly 70 percent of the 442 generic drugs approved by the FDA in 2019 remain unavailable to consumers.
Federal regulators have approved a record number of new generic medications in each of the last three years, but many of the new drugs are not making it to market.
Iqvia, a health research firm, reports that more than a third of the nearly 2,500 generic drugs approved since 2016 are available to consumers. Roughly 70 percent of the 442 approved in 2019 remain unavailable.
As a result, recent medical innovations have not had the beneficial impact on prices that would otherwise be expected.
Related: Overall costs for generic drugs decline, but consumers not seeing the savings
Generic drug manufacturers point the finger squarely at brand name competitors. Chip Davis, who heads the Association for Accessible Medicines, a trade group for generic drug-makers, tells the Wall Street Journal that big pharma firms are playing “patent games to protect profits and prevent competition.”
Hikma failed to launch a generic version of Zortress, a transplant drug, after getting hit with a patent infringement lawsuit by Novartis, which manufactures Zortress.
In many cases generic manufacturers agree to settlements with brand-name firms in which they agree to delay release of the generic version for years. In some cases, the brand-name manufacture pays to keep the competition off the market.
Sunovion, which makes Latuda, a popular drug prescribed for bipolar disorder, sued the maker of a generic version and got the competitor to agree to remain on the sidelines until 2023.
In some cases, generic manufactures are deciding to keep their drugs off-market even in the absence of a legal threat. Sometimes, experts say, they conclude that the medication isn’t going to be profitable, or at least not profitable enough.
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