Hovione manufactures simvastatin in its Macau facility
using the synthetic process described in the CKD patent WO 01/45484,
International Publication Date 28 of June of 2001.Simvastatin product patent situation in some countries is
summarized below:
| Country |
Patent Number |
Expiry Date |
SPC* Expiry
Date |
|
USA |
US 4
444 784 |
24 Apr.
2001 |
24 Dec.
2005 |
|
France |
EP 33
538 |
2 Feb.
2001 |
6 May
2005 |
|
UK |
EP 33
538 |
2 Feb.
2001 |
5 May 2003 |
|
West Germany |
EP 33
538 |
2 Feb.
2001 |
6 May
2003 |
|
Italy |
EP 33
538 |
2 Feb.
2001 |
1 Apr.
2009 |
|
Spain |
ES
86/9296 |
10 Oct.
2005 |
----- |
|
Portugal |
PT 72
441 |
3 Feb.
2001 |
----- |
|
Other Eur. Countries |
EP 33
538 |
2 Feb.
2001 |
April/May
2003 |
*SPC - Supplementary Protection Certificate
To view the synthetic route described in Merck’s product patent (US
4 444 784) (please click here).
CKD’s WO 01/45484 patent uses the same synthetic
route and passes through the same intermediates as the process
described in the product patent US 4 444 784, but it consists in an
improved process to prepare simvastatin with higher yield and higher
purity based on carrying out practically all the reactions in
different and advantageous mild conditions.
|
