Abbott receives FDA approval for generic version of iopamidol

Abbott could drive contrast prices even lower

Prices for x-ray contrast media in the U.S. could go even lower in the next several months after healthcare giant Abbott Laboratories introduces its generic version of iopamidol. The Food and Drug Administration ruled in December that a version of iopamidol developed by the Abbott Park, IL, company is the generic equivalent of Isovue, a nonionic, low-osmolar x-ray contrast agent developed by Bracco of Milan, Italy.

The expiration of Bracco's U.S. patents on iopamidol has prompted consternation among established contrast agent companies like Bracco, Nycomed, and Mallinckrodt, because generic versions of iopamidol will compete with low-osmolar nonionic products from all companies. The arrival of generic iopamidol is believed to be one of the factors behind the ongoing slump in prices for contrast agents, and the drop has prompted several contrast companies to seek mergers with other firms to reduce their reliance on the x-ray market.

Abbott is only one of several companies developing generic versions of iopamidol, with other potential competitors including ESI-Lederle, Hovione of Portugal, Faulding Pharmaceutical, and Brightstone Pharma. Faulding received FDA approval for its version of iopamidol in 1996 (SCAN 12/18/96).

Abbott's introduction of iopamidol could have the biggest impact on the market, however, due to the company's extensive distribution network. Abbott's small army of field sales representatives are already calling on hospitals regarding other products, and it should be relatively easy for the company to insert generic iopamidol into its product offerings. The company is planning to begin selling the product some time this spring, an Abbott spokesperson said.

Iopamidol will also round out Abbott's expanding product portfolio. The company already offers MRI and x-ray contrast agents it has accessed through an agreement signed in 1996 with Schering subsidiary Berlex Laboratories (SCAN 7/3/96). Abbott also has rights to EchoGen, an ultrasound contrast agent under development by Sonus Pharmaceuticals that is expected to be close to FDA approval.