Many Approved Generics Never Make It To Market

Brand-name manufacturers use legal maneuvers to keep cheaper competitors off the market
Robert Calandra

Generic drugs for cancer, heart disease, and other illnesses are getting approved in record numbers, but many are getting on the market.

The result is that payers and patients are missing out on the reason-to-be for generics: lower prices. 

Since 2016, the FDA has approved 2,492 generic versions of 617 brand-name pharmaceuticals, according to the Wall Street Journal citing the health-data firm, Iqvia. The number of generic approvals has set records for each of the past three several years

Yet less than two thirds of the generic drugs approved between 2016 and 2018 have reached the market. The newspaper reported that roughly 40% of last year’s 689 drug approvals haven’t been launched and that through June of this year only 30%, or 134 of the 442 approvals have gone on sale.

Biological drugs for ailments such as cancer and rheumatoid arthritis are launched less frequently. The Journal reports that only 11 products of the more than two dozen biosimilars  approved are currently available.

There are many reasons why many generic drugs never get produced. Generic industry insiders told the Journal that in some cases generic drug makers decide that the return on investment isn’t what they expected or that their plants aren’t ready to make the drugs. There has also been consolidation in the industry, reducing the number of companies willing to make and sell generics.

The versus never happens

But in many cases brand-name drug makers use legal maneuvers to aggressively defend product patents by filing additional patents and suing generic-drug companies.

 “It’s very troublesome,” said Ameet Sarpatwari, an instructor at Harvard Medical School whose research includes pharmaceutical regulation, told the Journal. “Prompt generic entry is the one known solution to lowering drug prices.”