2008: 5 positive opinions issued
1. Caspofungin
EU market authorization for Cancidas from Merck Sharp & Dohme Inc.
Dutch SPC nr. 300076, basic patent EP 620232 to Merck Sharp & Dohme Corp.
Last day of protection: 2017.04.23
This includes the 6 months extension that was granted
2. Ribavirin
EU market authorization for Rebetol from Schering-Plough Europe
SPC application nr.300083 based on EP 643970 to ICN Pharmaceuticals rejected in 2004
3. Peginterferon alfa-2b
(based on EMEA-000384-PIP01-08)
EU market authorization for ViraferonPeg from Schering-Plough Europe
Dutch SPC nr. 300127, basic patent EP 809996 to F. Hoffmann-La Roche AG
Last day of protection: 2017.06.19
SPC extension not yet requested
4. Peginterferon alfa-2b
(based on EMEA-000071-PIP01-07)
EU market authorization for PegIntron/ViraferonPeg from Schering-Plough Europe
Dutch SPC nr. 300127, basic patent EP 809996 to F. Hoffmann-La Roche AG
Last day of protection: 2017.06.19
SPC extension not yet requested
5. Zoledronic acid
EU market authorization for Zometa from Novartis Europharm Limited
Dutch SPC nr. 300058, basic patent EP 275821 to Novartis AG
Last day of protection: 2013.05.15
This includes the 6 months extension that was granted
Dutch SPC nr. 300059, basic patent EP 258618 to Roche Diagnostics GmbH
Last day of protection: 2012.07.24
SPC extension not yet requested
2009: 8 positive opinions issued
6. Losartan
National market authorization for Cozaar from Merck Sharp & Dohme Inc.
Dutch SPC nr. 950009, basic patent EP 253310 to E.I. du Pont de Nemours and Company
Last day of protection: 2010.03.01
This includes the 6 months extension that was granted
7.Anastrozole
National market authorization for Arimidex from AstraZeneca AB
Dutch SPC nr. 970012, basic patent EP 296749 to AstraZeneca UK Limited
Last day of protection: 2011.02.10
This includes the 6 months extension that was granted
8.Abatacept
EU market authorization for Orencia from Bristol-Myers Squibb Pharma
Dutch SPC nr.300303, basic patent EP 606217 to Bristol-Myers Squibb Company
Last day of protection: 2017.12.15
This includes the 6 months extension that was granted
9.Colesevelam
EU market authorization for Foster/Kantos/Inuvair from Genzyme Europe
Dutch SPC nr. 300159, basic patent EP 764174 to Genzyme Corp.
SPC extension not yet requested
10. Valsartan
National market authorization for Diovan from Novartis Europharm Limited
Dutch SPC nr. 970001, basic patent EP 443983 to Novartis AG
Last day of protection: 2011.05.12
Request for SPC extension currently (30.09.10) pending
11. Purified diphtheria toxoid / Purified tetanus toxoid / Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)] / Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett) / Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)
EU market authorization for Pediacel from Sanofi Pasteur MSD
Dutch SPC nr.300443, basic patent EP 835663 to GlaxoSmithKline Biologicals S.A
Last day of protection: 2015.10.01
SPC extension not yet requested
SPC applications nrs. 300403 and 300404 based on EP 1666057 and 300185, 300187 and 300188 based on EP 747058 all to Medeva are currently pending in view of ECJ C-332/10
12. Leucine / potassium acetate / cysteine / glutamic acid / praline / alanine / glycine / histidine / isoleucine / magnesium acetate tetrahydrate / olive oil, refined / methionine/ ornithine hcl / phenylalanine / tryptophan / valine/ taurine / tyrosine / sodium chloride / arginine / calcium chloride dihydrate / aspartic acid / serine / threonine / sodium glycerophosphate, hydrated / soya-bean oil, refined / lysine monohydrate / glucose monohydrate
Market authorization for ? from Baxter World Trade SA/NV
No Dutch SPC
13. Atorvastatin
National market authorization for Sortis, Lipitor, Tahor, Xarator, Zarator, Liprimar, Totalip, Torvast, Cardyl from Pfizer
Dutch SPC nr. 970034, basic patent EP 247633 to Warner-Lambert Company
Last day of protection: 2011.11.06
SPC extension not yet requested
2010: 7 positive opinions issued
14. Montelukast
National market authorization for Singulair from Merck Sharp & Dohme Ltd.
Dutch SPC nr. 990009, basic patent EP 480717 to Merck Frosst Canada Ltd.
Last day of protection: 2012.08.24
SPC extension not yet requested
15. Latanoprost
National market authorization for Xalatan from Pfizer Global Research & Development
Dutch SPC nr. 970039, basic patent EP 364417 to Pharmacia Aktiebolag
Last day of protection: 2011.07.17
SPC extension not yet requested
16. Human papillomavirus1 Type 6 L1 protein / human papillomavirus1 Type 11 L1 protein / human papillomavirus1 Type 16 L1 protein / human papillomavirus1 Type 18 L1 protein
EU market authorization for Gardasil from Sanofi Pasteur MSD
Dutch SPC nr. 300318, basic patent EP 647140 to Georgetown University
Last day of protection: 2018.06.23
Dutch SPC nr. 300264, basic patent EP 1015561 to Medimmune
Last day of protection: 2021.09.19
Dutch SPC nr. 300269, basic patent EP 1165126 to Merck & Co
Last day of protection: 2021.09.19
In all three cases SPC extension not yet requested
17. Nomegestrol acetate / 17 beta-estradiol
Market authorization for ? from Organon N.V.
No Dutch SPC
18. Esomeprazole
National market authorization for Nexium from AstraZeneca AB
Dutch SPC nr. 300027, basic patent EP 124495 to Aktiebolaget Hässle
Last day of protection: 2009.02.27
So SPC expired before extension could be filed
19. Midazolam
Market authorization for ? from ViroPharma SPRL
Dutch SPC application nr. 980040 based on NL 193145 withdrawn in 1999
20. Nevirapine
EU market authorization for Viramune from Boehringer Ingelheim International GmbH
Dutch SPC nr. 990022, basic patent EP 429987 to Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim Pharma GmbH
Last day of protection: 2012.12.22
SPC extension not yet requested
Thanks Martijn!
No comments:
Post a Comment