The present invention relates to an improved method of preparing adefovir dipivoxil of Formula 1. The method of the present invention is characterized by using dimethylsulfoxide as a reaction solvent and comprises a process of preparing adefovir dipivoxil of Formula 1 by allowing adefovir of Formula 2 to react with chloromethylpivalate at a reaction temperature of 30 to 50° C. under the presence of dimethylsulfoxide and triethylamine solvents.

Disclosed are highly stable compositions having outstanding storage stability and/or demonstrating exceptional resistance to aqueous solution degradation the composition including an orally active nucleotide analogue or an orally active nucleotide analogue prodrug which is orally bioavailable such as adefovir dipivoxil and tenofovir disoproxil. For example when a composition of the invention is stored for 1 month or for 18 months at 25° C. and 60% relative humidity its orally active nucleotide a...

The invention provides crystalline forms of adefovir dipivoxil and methods to prepare the crystals. The compositions and methods of the present invention have desirable properties for large scale synthesis of crystalline adefovir dipivoxil or for its formulation into therapeutic dosages. Invention compositions include an anhydrous crystal form of adefovir dipivoxil.

Disclosed are highly stable compositions having outstanding storage stability and/or demonstrating exceptional resistance to aqueous degradation the composition including an orally active nucleotide analogue or an orally active nucleotide analogue prodrug which is orally bioavailable such as adefovir dipivoxil and tenofovir disoproxil. In particular molecular dispersions of adefovir dipivoxil in copovidone are disclosed. For example when a composition of the invention is stored for 1 month or fo...

601519 Disclosed is a pharmaceutical composition for treating hepatitis B virus infection in a human comprising: a first active pharmaceutical ingredient consisting of more than 400 mg to about 1500 mg of lamivudine (2Rcis)-4-amino-1-(2-hydroxymethyl-13-oxathiolan-5-yl)-pyrimidin-2-one or a therapeutically equivalent amount of a pharmaceutically acceptable salt or ester thereof; and a second active pharmaceutical ingredient consisting of about 1 mg to about 10 mg of adefovir dipivoxil bis(pivalo...