Ranbaxy Labs got the tentative approval from the USFDA to manufacture and market Valganciclovir Hydrochloride Tablets, 450 mg. Ranbaxy is First Para IV filer generic company and is entitled for 180 days exclusivity. Ranbaxy and innovator Roche are in litigation on US6083953 (Expiry: Mar 29, 2015) which covers 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-3-hydroxy-1-propanyl-L-valinate hydrochloride (Valganciclovir) in crystalline form as product.
Ranbaxy has designed around the '953 patent by preparing their formulation by amorphous form of Valganciclovir (as patent covers crystalline form). Roche in its complaint has alleged that on stability Ranbaxy product will convert to crystalline form.
Innovator Roche got approval on this product on Mar 29, 2001 for the treatment of Cytomegalovirus and is mainly used for eye infection, on absorption this drug is converted into the body into Ganciclovir by esterase enzymes present in intestine and liver.
