There are numerous ways for makers of pricey brand-name drugs to delay the release of generic copies and hold on to the market for even a few months longer. They could make slight changes to the doses or even go so far as to buy a company that supplies a needed ingredient. But one pharmaceutical company is taking a new approach to putting off the release of generic versions — etching an additional score into the pill’s surface.
Generic versions of Doryx (doxycycline hyclate), an antibiotic used to treat severe acne and produced by Irish company Warner Chilcott, were slated to hit the market at the end of September. But, argues Warner, its recent addition of a second score to the pill — making it easier for users to divide the pill into three pieces — means that generic versions must also have the same number of scores.
Explains the Wall Street Journal:
Approving generic tablets with just one score, Warner Chilcott said in its petition filed with FDA, “would raise public health concerns.” A doctor could write a prescription for Doryx and instruct a patient to divide the tablet into thirds, but a generic version with just one score would make it difficult to get the right dose, the company said.
Warner Chilcott stands to lose a chunk of cash if the market is opened up to generics. In just the U.S. alone, more than 383,000 take Doryx. In 2010, the drug raked in $172.6 million for the company, which the Journal reports is around 6% of Warner Chilcott’s total revenue from last year.
Around the same time as Warner Chilcott asked FDA to reject generics with only one score, it got a U.S. District Court in New Jersey to issue a preliminary injunction against another drug company, Mylan, which had planned to release a generic version of Doryx but who Warner Chilcott alleges is guilty of infringing on patents.