X-ray nonionic market heats up with FDA approval of Faulding's iopamidol

Faulding beats Abbott to market with generic product

Yet another generic nonionic x-ray contrast medium could be onthe U.S. market within three months. The Food and Drug Administrationconcluded this month that a product proposed by Faulding Pharmaceuticalof Elizabeth, NJ, is the generic equivalent of Isovue, a nonionic,low-osmolar agent developed by Italian pharmaceutical giant Bracco.

Faulding plans to begin marketing a generic version of Isovue(iopamidol) in early 1997, according to CFO Lee Craker.

The company's majority shareholder, the Australian pharmaceuticalcompany F.H. Faulding & Co., is already ramping up productionof iopamidol. The agent will be made available in 61% and 76%solutions, the generic equivalents of Isovue 300 and Isovue 370.

Isovue accounts for about one-third of the total U.S. nonionicmarket, with clinical indications in angiography, adult and pediatricexcretory urography, and adult and pediatric contrast enhancementin head and body CT. The incursion by Faulding into this marketcould impact Bracco's sales of Isovue, and could also affect nonionicproducts from other contrast companies.

Craker did not provide details about pricing, but he expectsthat the availability of Faulding's generic iopamidol will resultin a price drop by manufacturers of nonionics.

"When generic products come out, you see reductions inprice and, therefore, the overall cost of healthcare comes down.That is the way the generic process usually works," he said."The more competitive the industry, the more price-sensitivethe product becomes."

But John Campbell, director of marketing at Bracco Diagnosticsin Princeton, NJ, disagrees with that assessment.

"I don't see a significant impact (by Faulding) on themarketplace," Campbell said. "It is already very cost-competitive,so I don't think you will see the type of impact from potentialgeneric entrants that you would see in a traditional pharmaceuticalmarketplace."

Campbell notes that discounting is already widespread in thenonionic, low-osmolar marketplace, primarily as the result ofagreements struck over the last year between major vendors andgroup purchasing organizations.

"It is a complicated marketplace involving not just thetraditional clinicians but risk managers, hospital administrators,and group purchasing organizations, all requiring different typesof services and information," he said. "The key playersare those that have focused on this particular market niche, andoffer specialized products and services and very specialized packaging."

Further mitigating any impact on Bracco and providers of othersuch agents may be the tendency of generics to increase interestin purchasing the product type. Traditionally, volume sales increaseif prices drop, because the product is more affordable. As a result,if revenues are lost in terms of unit prices by the vendors ofnon-generic products, those losses tend to be offset, at leastpartially, by increased sales.

Whatever happens, Faulding's introduction could be only thebeginning. Other companies in the U.S., Europe, and Japan haveindicated interest in manufacturing iopamidol. If those productsare developed, they could cut into the global market for Isovue,which is one of the four best-selling x-ray contrast media inthe world.

Despite Faulding's early start, the biggest challenge to Isovuesales in the U.S. may come from Abbott Laboratories, which hassubmitted to the FDA an abbreviated new drug approval (ANDA) applicationregarding iopamidol (SCAN 11/20/96). The Abbott Park, IL, companyhas an extensive distribution network and an average of five contractsper hospital in the U.S. Abbott executives believe these contractscould provide the basis for a relatively easy transition intothe contrast market.

Abbott also plans to offer iopamidol in a variety of concentrationsand in soft plastic packages that will allow easy administrationto patients.

"Our ANDA is still pending, but with iopamidol, althoughwe won't be first to market with a generic, we will have a differentiateddelivery system that will make us competitive," said LaureenCassidy, spokesperson for Abbott.

In its effort to penetrate the U.S. market, Faulding plansto leverage both a direct sales force and distributors. The companyhas extensive experience in the sale of generics. About 99% ofits products are of this type, and Faulding's generics accountedfor more than $14 million in revenue during 1995.

Iopamidol will be the company's first contrast agent. Its batteryof generic products is focused on antibiotics and anti-infectives,cardiovascular drugs, anti-inflammatories, analgesics, and antidepressantsand tranquilizers. Faulding Pharmaceutical's iopamidol applicationwas the company's seventh FDA submission for a generic productto win approval from the agency in 1996. Five others are pending.