Amid FDA competition push, Hikma jacks up a handful of drug prices as much as 430%

Generic drug prices may be depressed enough to bring down the mood of many a copycat drugmaker, but that doesn’t mean prices on some unusual formulas aren’t going up. Just ask Hikma Pharmaceuticals, which posted a half-dozen big price rises just this month.

The Jordan-based company restickered a range of drugs sold by its U.S. unit, West-Ward Pharmaceuticals, the Financial Times reports, including common steroid prednisone, decades-old mood stabilizer lithium and heart drug digoxin, better known as digitalis, mostly in liquid formulations with little competition.

The price increases come amid a push by FDA Commissioner Scott Gottlieb to speed up approval of copycat drugs in order to foster competition and bring down prices. The agency plans to prioritize generic applications in areas in which only a few products are available.

West-Ward’s biggest hike hit its version of diarrhea medication Lomotil. The liquid formulation of diphenoxylate-atropine went up to $84 per bottle from $15.83, a 431% increase, the FT says. Two liquid formulations of prednisone more than doubled in price; prednisone's price went up by 190% to $96 per 120-ml bottle, while the price of prednisone intensol went up by 172% to $156 per 30-ml bottle.

Generic drugs that run pennies per tablet can command higher prices in other formulations, particularly injectables and patches, but also liquids, salves, sprays and more. Such formulas can be more difficult to produce than standard-fare tablets are. In recent years, as competition among generics makers has grown more fierce and prices declined, companies have diversified into other dosage forms in an attempt to fend off rivals and increase profit margins.

West-Ward says the individual hikes stand out in a portfolio whose prices have declined overall. Brian Hoffman, president of the company’s U.S. generics business, told the FT that the prices on 94% of its generic drugs have stayed the same or fallen this year. But then, generic drug prices have fallen for all drugmakers this year as consolidation gave wholesalers more leverage to demand cheaper prices.

The company made "price adjustments" on a "small number of products [that] required investment … to become commercially viable," Hoffman told the newspaper, including investments in new manufacturing capacity.

Hikma spent $2.65 billion last year to buy Roxane Labs, which brought the company additional manufacturing capacity. It came with a 875,000-square-foot manufacturing site in Columbus, Ohio, where Roxane manufactured 88 products. While its particular strength was in immediate-release solids, it also produced liquid, dry-powder inhaler and nasal-spray dosage forms. It also made high-potency products, technically complex formulations and controlled substances.

West-Ward’s liquid prednisone was approved by the FDA in 1984, and prednisone intensol was approved in 1985, according to the FDA Orange Book. Those two products are among only four nontablet generic formulations of the drug; more than 120 tablet versions are FDA-approved. West-Ward’s 5-mg prednisone tablets are available for 19 cents each, the FT says.

In June, the FDA rolled out plans to streamline generics’ path to market. By putting generic candidates with little competition at the front of its review line, the FDA could shepherd the new copycats to market relatively quickly. In formulating the policy, the agency reviewed data showing that consumers see real price relief when several competitors are fighting for share. When only two generic products are on the market, discounts typically aren’t as high.