MORRISTOWN, N.J.—Watson Pharmaceuticals Inc. said July 12 that it has submitted an application to the U.S. Food and Drug Administration to approve a generic form of Genzyme’s phosphate binder Renvela.
Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease patients on dialysis.
Watson’s Abbreviated New Drug Application is for sevelamer carbonate for oral suspension, 0.8g and 2.4g per packet.
In response to the application, Genzyme filed a lawsuit against Watson on July 9 in the United States District Court for the District of Maryland seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,667,775, Watson said in a July 12 news release.
Genzyme's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Paragraph IV” certification was created by the Drug Price Competition and Patent Term Restoration Act of 1984. This act, also known as the Hatch-Waxman Act for Rep. Henry Waxman, D-Calif., and Sen. Orrin Hatch, R-Utah, established the modern system of generic drugs.
The Hatch-Waxman Act, however, allows the branded company to block the FDA approval process by filing suit, which Genzyme did. As a result of the lawsuits, the FDA stays final approval of the generic drugs until one of three things happens: 1) patent expiration; 2) a final determination by a court of non-infringement or patent invalidity; or 3) the expiration of a 30-month period from the time the ANDA filer notifies the patent holder of a Paragraph IV certification.
This is the second challenge this month to Genzyme’s phosphate binder. On July 2, Impax Laboratories confirmed that it submitted an ANDA to the FDA for a generic version of Renvela. On July 1, 2010, Genzyme filed suit for patent infringement against Impax in the United States District Court for the District of Maryland.
