Patent Information

Application Number
1427/DELNP/2003
Patent Number
197007
Invention Field
PHARMACEUTICALS
Publication Type
Publication Number
18/2005
Status
Grant Date
Filing Date
2003-09-08
Grant Date
2006-08-11
Renewal Date
2022-03-13

Abstract

Atorvastatin calcium, the substance known by the chemical name (R-(R*,R*))-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(l-methylethyl)-3-phenyl-((phenylamino)carbonyl)-lH-pyrrole-1-heptanoic acid hemi calcium salt is known as HMG-CoA reductase inhibitor and is used as an antihypercholesterolemic agent. Atorvastatin in the pharmaceutical compositions available in the market, is usually prepared as its calcium salt since it enables atorvastatin to be conveniently formulated in the pharmaceutical formulations, for example, in tablets, capsules, powders and the like for oral administration. Atorvastatin calcium can exist in an amorphous form or in one of the at least four known crystalline forms (Form I, Form II, Form III and Form IV). Atorvastatin calcium is the substance which is sparingly soluble in water, with pKa 4,5, and it has been found that the crystalline forms are less soluble than the amorphous form, which may cause problems in bioavailability of atorvastatin in the body. The present invention solves the problem of providing therapeutic equivalence of atorvastatin pharmceutical formulation regardless the form (crystalline, amorphous, mixture of both) of atorvastatin calcium used for its preparation.

Applicants

1. LEK PHARMACEUTICAL AND CHEMICAL COMPANY D.D.
VEROVSKOVA 57, 1526 LJUBLJANA, SLOVENIA.

Inventors

1. KERC, JANEZ
TREBINJSKA 7, 1000 LJUBLJANA, SLOVENIA.
2. MATEJA, SALOBIR
UL.28. MAJA 9, 1000 LJUBLJANA, SLOVENIA.
3. BAVEC, SASA
MEKINCEVA 15, 1000 LJUBLJANA, SLOVENIA.

Specification

1. KERC, JANEZ
TREBINJSKA 7, 1000 LJUBLJANA, SLOVENIA.
2. MATEJA, SALOBIR
UL.28. MAJA 9, 1000 LJUBLJANA, SLOVENIA.
3. BAVEC, SASA
MEKINCEVA 15, 1000 LJUBLJANA, SLOVENIA.

Eregister



Year CBR Date CBR Number Renwal Amount Renwal Date Normal Due Date Renwal To Renwal From Due Date with Extension Reneal Certificate Number
3rd year 14/11/2006 19790 2000 14/11/2006 19/09/2006 13/03/2005 13/03/2004 19/03/2007 2646
4th year 14/11/2006 19790 2000 14/11/2006 19/09/2006 13/03/2006 13/03/2005 19/03/2007 2646
5th year 14/11/2006 19790 2000 14/11/2006 19/09/2006 13/03/2007 13/03/2006 19/03/2007 2646
6th year 14/11/2006 19790 2000 14/11/2006 13/03/2007 13/03/2008 13/03/2007 13/09/2007 2646
7th year 07/03/2007 21853 6000 07/03/2007 13/03/2008 13/03/2009 13/03/2008 13/09/2008 859
8th year 04/03/2008 1512 6000 04/03/2008 13/03/2009 13/03/2010 13/03/2009 13/09/2009 1001
9th year 12/02/2009 1161 6000 12/02/2009 13/03/2010 13/03/2011 13/03/2010 13/09/2010 1047
10th year 18/02/2010 1466 6000 18/02/2010 13/03/2011 13/03/2012 13/03/2011 13/09/2011 1681
11th year 14/02/2012 1377 12000 14/02/2012 13/03/2012 13/03/2013 13/03/2012 13/09/2012 1532
12th year 07/02/2013 1331 12000 07/02/2013 13/03/2013 13/03/2014 13/03/2013 13/09/2013 1364
13th year 23/01/2014 950 12000 23/01/2014 13/03/2014 13/03/2015 13/03/2014 13/09/2014 762
14th year 11/02/2015 3070 24000 11/02/2015 13/03/2015 13/03/2016 13/03/2015 13/09/2015 2815
15th year 11/02/2016 3144 24000 11/02/2016 13/03/2016 13/03/2017 13/03/2016 13/09/2016 3288
16th year 23/02/2017 7472 40000 23/02/2017 13/03/2017 13/03/2018 13/03/2017 13/09/2017 7039
17th year 23/02/2018 4938 40000 23/02/2018 13/03/2018 13/03/2019 13/03/2018 13/09/2018 8500
18th year 21/02/2019 5621 40000 21/02/2019 13/03/2019 13/03/2020 13/03/2019 13/09/2019 8225
19th year 20/02/2020 6264 40000 20/02/2020 13/03/2020 13/03/2021 13/03/2020 13/09/2020 12819
20th year 19/02/2021 5771 40000 19/02/2021 13/03/2021 13/03/2022 13/03/2021 13/09/2021 11839

Specification

Documents

Documents
Name Date
1 1427-delnp-2003-abstract.pdf 2011-08-21
2 1427-delnp-2003-claims.pdf 2011-08-21
3 1427-delnp-2003-complete specification (asfiles).pdf 2011-08-21
4 1427-delnp-2003-complete specification (granted).pdf 2011-08-21
5 1427-delnp-2003-correspondence-others.pdf 2011-08-21
6 1427-delnp-2003-correspondence-po.pdf 2011-08-21
7 1427-delnp-2003-description (complete).pdf 2011-08-21
8 1427-delnp-2003-form-1.pdf 2011-08-21
9 1427-delnp-2003-form-19.pdf 2011-08-21
10 1427-delnp-2003-form-2.pdf 2011-08-21
11 1427-delnp-2003-form-3.pdf 2011-08-21
12 1427-delnp-2003-form-5.pdf 2011-08-21
13 1427-delnp-2003-pct-101.pdf 2011-08-21
14 1427-delnp-2003-pct-210.pdf 2011-08-21
15 1427-delnp-2003-pct-220.pdf 2011-08-21
16 1427-delnp-2003-pct-301.pdf 2011-08-21
17 1427-delnp-2003-pct-304.pdf 2011-08-21
18 1427-delnp-2003-pct-308.pdf 2011-08-21
19 1427-delnp-2003-pct-332.pdf 2011-08-21
20 1427-delnp-2003-pct-408.pdf 2011-08-21
21 1427-delnp-2003-pct-409.pdf 2011-08-21
22 1427-delnp-2003-pct-416.pdf 2011-08-21
23 1427-delnp-2003-petition-138.pdf 2011-08-21