Novartis Pharmaceuticals has filed two lawsuits over SangStat’s SangCya, a new cyclosporine oral solution that has brought direct competition to Novartis’ Neoral.
One suit was filed against the Food and Drug Administration, alleging that the FDA “did not follow its own regulations in designating SangStat’s nonidentical cyclosporine dosage form as directly substitutable for Neoral,” Novartis said. The FDA approved SangCya—a less expensive cyclosporine than Neoral—in October.
“As a result of the recent FDA approval, transplant patients can be switched to a different cyclosporine dosage form by the dispensing pharmacist without the knowledge and supervision of their physicians,” said Kenneth Somberg, MD, executive director of medical affairs for Novartis. “We believe that because these products have different dosage forms, physicians should be notified of any switch.”
In the second suit, a patent infringement suit against SangStat, Novartis claims that SangStat’s product employs a cyclosporine technology invented and patented by Novartis.
SangStat said in a statement that both suits are without merit” and that Novartis is “trying to protect” its cyclosporine market from SangStat’s cheaper alternative. SangStat called the suits “another attempt by Novartis to preserve its monopoly in the marketplace to the potential detriment of transplant recipients who require life-long treatment with this expensive lifesaving medication.”
Based on current pricing, SangStat estimated that SangCya could potentially save recipients, transplant centers, and health care payors as much as $100 million per year.
Both lawsuits were filed on February 11.
For Your Information:
Novartis statement:
http://www.novartis.com/media/press_notes_www/32e2_1a6.htmSangStat statement
http://www.sangstat.com/press/press_release99-08.html
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