GlaxoSmithKline has sued Lupin Pharma for developing a generic version of Combivir (LAMIVUDINE; ZIDOVUDINE), a combination to treat HIV patients.
Innovator GSK got approval to market LAMIVUDINE (150 mg)+ ZIDOVUDINE (300mg) on September 26, 1997
Lupin has filed para IV against following Orange Book listed patents
US5047407 (Expiry: May 17, 2010): which covers Methods and compositions for preventing or treating human immunodeficiency virus (HIV) infections characterized by 2-substituted-5-substituted-1,3-oxathiolanes.
US5859021 (Expiry: May 15, 2012): Which covers a combination of anti-HIV compounds which comprises a mixture of first and second compounds wherein said first compound is (2R,cis)-4-amino-1-(2-hydroxy-methyl-1,3-oxathiolan-5-yl)-1 H-pyrimidin-2-one or a pharmaceutically acceptable salt, ester or salt of said ester of said first compound and said second compound is 3'-azido-3'-deoxythymidine or a pharmaceutically acceptable salt, ester or salt of said ester of said second compound with the proviso that said first and second compounds of said combination are present in a ratio wherein the ratio of said first compound to said second compound is from about 1:2 to about 1:1 by weight.
US5905082 (Expiry: Nov 18, 2016):Which covers a pharmaceutical formulation in solid dosage unit form comprising an effective amount of (-)-cis-4-amino-1-(2-hydroxymethyl)-1,3-oxathiolan-5-yl)-(1H)pyrimidine-2- one in bipyramidal crystalline form and a pharmaceutically acceptable carrier therefor.US7119202 (Expiry:Aug 8, 2009) which covers 1. Cis-2-hydroxymethyl-5-(cytosin-1'-yl)-1,3-oxathiolane substantially in the form of a single enantiomer or a pharmaceutically acceptable salt thereof.
Innovator GSK got approval to market LAMIVUDINE (150 mg)+ ZIDOVUDINE (300mg) on September 26, 1997
Lupin has filed para IV against following Orange Book listed patents
US5047407 (Expiry: May 17, 2010): which covers Methods and compositions for preventing or treating human immunodeficiency virus (HIV) infections characterized by 2-substituted-5-substituted-1,3-oxathiolanes.
US5859021 (Expiry: May 15, 2012): Which covers a combination of anti-HIV compounds which comprises a mixture of first and second compounds wherein said first compound is (2R,cis)-4-amino-1-(2-hydroxy-methyl-1,3-oxathiolan-5-yl)-1 H-pyrimidin-2-one or a pharmaceutically acceptable salt, ester or salt of said ester of said first compound and said second compound is 3'-azido-3'-deoxythymidine or a pharmaceutically acceptable salt, ester or salt of said ester of said second compound with the proviso that said first and second compounds of said combination are present in a ratio wherein the ratio of said first compound to said second compound is from about 1:2 to about 1:1 by weight.
US5905082 (Expiry: Nov 18, 2016):Which covers a pharmaceutical formulation in solid dosage unit form comprising an effective amount of (-)-cis-4-amino-1-(2-hydroxymethyl)-1,3-oxathiolan-5-yl)-(1H)pyrimidine-2- one in bipyramidal crystalline form and a pharmaceutically acceptable carrier therefor.US7119202 (Expiry:Aug 8, 2009) which covers 1. Cis-2-hydroxymethyl-5-(cytosin-1'-yl)-1,3-oxathiolane substantially in the form of a single enantiomer or a pharmaceutically acceptable salt thereof.
US7119202 (Expiry:Aug 8, 2009): which covers Cis-2-hydroxymethyl-5-(cytosin-1'-yl)-1,3-oxathiolane substantially in the form of a single enantiomer or a pharmaceutically acceptable salt thereof.
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