Ranbaxy Gets Tentative Approval for Generic Valcyte

Ranbaxy Laboratories has received tentative approval from the FDA to manufacture and market valganciclovir HCl 450-mg tablets, a generic version of Roche’s anti-viral Valcyte. 

Ranbaxy said it has first-to-file status, granting it 180 days of marketing exclusivity for the product.

Valcyte (valganciclovir HCl) treats cytomegalovirus retinitis, an eye infection that can cause blindness. The disease affects AIDS patients and people receiving high-risk kidney, kidney-pancreas and heart transplants.

Ranbaxy notified Roche in a March 17, 2006, letter that it had filed an ANDA for its generic anti-viral, which would not infringe on the ’953 patent covering Valcyte’s active ingredient. The company asserted that its product contains the active ingredient in an amorphous form rather than the crystalline form claimed in the patent, according to court documents. Roche sued Ranbaxy in May 2006 in the U.S. District Court for the District of New Jersey for infringing on the ’953 patent, which expires in March 2015.

In its complaint, Roche said it had requested samples of the active ingredient from Ranbaxy but did not receive them in a timely manner. It also asserted Ranbaxy’s generic version would convert to the crystalline form during ordinary use by doctors and patients.