Magazine article Drug Topics

Another Cyclosporine Product Enters Transplnt Market

Magazine article Drug Topics

Another Cyclosporine Product Enters Transplnt Market

Article excerpt

In the uniform world of generic drugs, one distinguishing characteristic can sometimes make all the difference. In the case of a newly introduced generic cyclosporine product, three factors may set it apart from the brand formulation.

Manufactured by Abbott Laboratories and SangStat, Gengraf (cyclosporine capsules, USP [modified]) has recently been approved as a bioequivalent alternative to Neoral (cyclosporine capsules USP [modified], Novartis) in the prevention of organ rejection in kidney, liver, and heart transplants.

Gengraf's manufacturers hope their product will be preferred on the basis of its capsule size, smell, and competitive pricing. The immunosuppressive drug comes as a hard-shell capsule that is smaller than Neoral, and, according to SangStat, easier for patients to swallow In regard to odor, a small study was conducted in which 101 healthy volunteers were asked to sniff both Neoral and Gengraf. Of the participants, 94% preferred the aroma of Gengraf.

The new generic product will be priced at approximately a 10% discount to Neoral, with an estimated cost of $41.27 for a 30-count box of 25-mg capsules. "Competitive pricing of Gengraf makes the product attractive, especially for patients who are paying out of pocket for their medications after transplant," noted Sophie Wimberley, Pharm.D., clinical pharmacist, Transplantation, Loyola University Medical Center.

But Neoral is not the only cyclosporine product on the block that Gengraf will be competing with. Eon Labs received approval for its cyclosporine modified capsules in January, but the company reportedly needed time to build up an adequate supply of the drug and to reach a comarketing agreement with another manufacturer. As a result, Eon's product is entering the market at the same time as Gengraf and appears also to be priced at a 10% discount to Neoral. Eon's 30-count box of 25mg capsules will cost $40.10.

The bioequivalence of Gengraf to Neoral was demonstrated in two well-controlled pharmacokinetic trials. In a six-month study of 100 de novo transplant patients who were randomized to Neoral or Gengraf, numbers of acute rejection rates were similar in both groups. The rates of cyclosporine-- associated nephrotoxicity was similar between the two patient groups as well. …

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