Brightstone Pharma files application to sell generic iopamidol contrast

Pharmaceutical developers are swarming over the market for generic iopamidol like ants at a summer picnic. The latest company to announce its intentions to sell the low-osmolar x-ray contrast medium in the U.S. is Brightstone Pharma of Cary, NC, the U.S. subsidiary of SkyePharma in the U.K.

Brightstone announced last month that it has filed an abbreviated new drug application (ANDA) with the Food and Drug Administration for iopamidol injection, a generic alternative to Bracco's Isovue. Isovue went off-patent last year, opening the door to generic competition, and a raft of companies have publicly said that they intend to sell generic iopamidol (SCAN 3/5/97).

To develop its version of iopamidol, Brightstone has partnered with another company that has an exclusive agreement with a supplier of the raw material for the agent, according to a Brightstone spokesperson. Brightstone's iopamidol will be produced in the Netherlands by a contract manufacturer that the company declined to identify. Brightstone expects that its ANDA will be approved in the first quarter of 1999.

Brightstone will sell iopamidol in 41%, 61%, and 76% concentrations, and will market the product through its own hospital-based sales force. The company's target market will include hospitals, clinics, integrated healthcare networks, HMOs, and other types of healthcare facilities that routinely use x-ray contrast.

Brightstone was formed in January 1996 as a subsidiary of SkyePharma of London, which itself was founded in late 1995. The company's focus is on generic drugs, although it is developing some branded pharmaceuticals as well. Brightstone is selling four generic drugs, including cimetidine, a version of gastrointestinal drug Tagamet, and glyburide, a version of diabetes drug Micronase. Brightstone does not develop drugs in-house, preferring to access them either through SkyePharma sister companies or through agreements similar to the iopamidol deal.

When Brightstone's generic iopamidol does hit the market, it will join products under development by Abbott Laboratories of Abbott Park, IL, Hovione of Portugal, Faulding Pharmaceutical of Elizabeth, NJ, and ESI-Lederle, a division of American Home Products. Even x-ray contrast developers are getting into the market, with Norway's Nycomed acquiring rights to generic iopamidol from Fujisawa USA (SCAN 6/11/97).