Claims for Patent: 9,642,911

Summary for Patent: 9,642,911

Title:	Pharmaceutical dosage forms comprising valganciclovir hydrochloride
Abstract:	The present invention provides novel solid pharmaceutical dosage forms for oral administration, after being constituted in water. The solid dosage forms comprise a therapeutically effective amount of valganciclovir hydrochloride and a non-hygroscopic organic acid present in an amount sufficient to stabilize the valganciclovir hydrochloride in a predetermined amount of water. The present invention also provides novel liquid pharmaceutical dosage forms for oral administration after constituting the solid pharmaceutical dosage form with water. A non-hygroscopic bulking agent may optionally be included in the above dosage form. These novel pharmaceutical dosage forms are useful in the treatment or control of viruses such as herpes simplex virus and cytomegalovirus. The present invention also provides a method for treating these diseases employing the solid and liquid pharmaceutical dosage forms and a method for preparing these pharmaceutical dosage forms.
Inventor(s):	Bachynsky; Maria Oksana (Nutley, NJ), Infeld; Martin Howard (Upper Montclair, NJ), Shah; Navnit Hargovindas (Clifton, NJ)
Assignee:	Hoffmann-La Roche Inc. (Little Falls, NJ)
Application Number:	14/529,839
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,642,911
Patent Claims:	1. A liquid pharmaceutical dosage form for oral administration, wherein the dosage form has the following composition: TABLE-US-00005 Constituted Soln Components Per mL Valganciclovir HCl 55.15 mg.sup.1 Povidone K30 2.00 mg Fumaric Acid 2.00 mg Sodium Benzoate 1.00 mg Sodium Saccharin 0.25 mg Mannitol 57.80 mg Tutti-Frutti Flavor 1.80 mg Purified Water 0.91 mL .sup.1Equivalent to 50 mg of valganciclovir (as free base) on a dry basis.